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calopre 03-08-10 17:22

portafoglio titoli pharma
 
XOMA
NASDAQ LABOPHARM
NASDAQ ARYX THERAPEUTICS
NASDAQ ISTA PHARMACEUTICAL
NASDAQ LEXICON PHARMA
NASDAQ PONIARD PHARM
AMEX ULURU
manca exas da cui ancora una volta sono uscito per buon profitto e in attesa di rientrare
Praticamente vi propongo il mio portfolio sui titoli pharma
attendo di conoscere il vostro per un maggiore riscontro e conoscenza sui singoli titoli

calopre 03-08-10 17:39

ARYx attualmente ha quattro candidati riservati della droga nella clinica e nei cavi supplementari che subiscono l'ottimizzazione. Mentre le nostre tecnologie possono applicarsi alle droghe orali, agli agenti d'attualità e ai injectables per un'ampia varietà di indicazioni di malattia, i nostri candidati iniziali sono droghe orali hanno mirato i mercati at large e cronici. I nostri residui clinici correnti sono:


ATI-7505
Disordini gastrointestinali

Budiodarone (ATI-2042)
Fibrillazione atriale

Tecarfarin (ATI-5923)
Anticoagulazione

ATI-9242
Disordini psichiatrici


ATI-7505 - Disordini gastrointestinali
ATI-7505 è un tipo riservato 4 della serotonina agonista (5HT4) nello sviluppo di fase 2 per il trattamento dei disordini gastrointestinali multipli. Le indicazioni potenziali comprendono la costipazione cronica, la dispepsia funzionale, la malattia di riflusso gastroesophageal (GERD), il gastroparesis (svuotamento in ritardo dello stomaco) e la malattia di viscere infiammatoria con costipazione. Ciascuna di queste indicazioni parla alle popolazioni pazienti significative. L'efficacia degli agonisti 5HT4 nei disordini gastrointestinali è affermata, anche se le responsabilità cardiache serie hanno limitato significativamente il loro uso. ATI-7505 è destinato per fornire l'attività prokinetic nel tratto gastrointestinale senza problemi di sicurezza cardiaci ai doeses terapeutici preveduti.

Budiodarone (ATI-2042) - fibrillazione atriale
Budiodarone è un residuo riservato nello sviluppo di fase 2 per il trattamento della fibrillazione atriale (AFIB). ARYx ha costruito il budiodarone con l'obiettivo di sviluppare una terapia ugualmente efficace ma più sicura dell'amminodarone, considerato dai medici come la droga più efficace per la cura dei pazienti con la fibrillazione atriale. Anche se l'amminodarone non è approvato per il trattamento della fibrillazione atriale, rimane il leader di mercato. Il trattamento di AFIB con amminodarone è stato limitato severamente dagli effetti secondari tossici derivando dall'accumulazione della droga. Budiodarone è destinato per conservare l'efficace farmacologia di amminodarone mentre attenua i problemi di sicurezza.

Tecarfarin (ATI-5923) - anticoagulazione
Tecarfarin, un residuo del romanzo per la terapia orale di anticoagulazione, è attualmente nei test clinici di fase 2/3. ARYx ha progettato il tecarfarin per conservare l'efficacia e la farmacologia complessa di Coumadin® (warfarin), il leader di mercato corrente, mentre migliora il profilo di sicurezza. Come warfarin, il tecarfarin esaurisce determinate proteine di coagulazione nell'anima, quindi riducente l'avvenimento di trombosi profonda della vena (DVT) ed il rischio di colpo connesso con la fibrillazione atriale (AFIB). Tecarfarin è metabolizzato dagli enzimi non-ossidativi ad una singola entità inattiva e finora sembra avere meno metabolismo variabile e casi riduttori di di sotto/sopra anticoagulazione, rendenti la risposta al tecarfarin più sicura e più prevedibile.

ATI-9242 - Disordini psichiatrici
ATI-9242 è destinato per essere un romanzo, un antipsicotico atipico next-generation per il trattamento della schizofrenia ed altri disordini psichiatrici. Crediamo che questo prodotto migliori sull'efficacia di migliori atypicals mentre eviti le interazioni metaboliche della droga-droga e minimizzando determinati altri problemi metabolici connessi con i atypicals, compreso guadagno di peso e tipo - il diabete 2. Il profilo del ricevitore di ATI-9242 è destinato per trattare i sintomi negativi della schizofrenia - riduzione dell'interazione sociale, disassociation dalla gente o regolazioni, discorso monotono, perdita di sensibilità di piacere - e per aumentare le funzioni conoscitive. Abbiamo entrato nella clinica con ATI-9242 nell'aprile 2008.

Più informazioni
Per più informazioni sui nostri prodotti ed occasioni partnering, metta in contatto con prego ARYx.
ATI-7505 - DisordersBudiodarone gastrointestinale

(ATI-2042) - FibrillationTecarfarin atriale

(ATI-5923) -

AnticoagulationATI-9242 -

applicazioni

psichiatriche di DisordersFuture


Tecarfarin (ATI-5923) è un anticoagulante orale nei test clinici di fase 2/3 per il trattamento dei pazienti che sono al rischio per la formazione di coaguli di sangue pericolosi.


questo titolo con grandi prospettive ha l'incognita del tempo e della cassa,a questi valori potrebbe essere oggetto di acquisizione anche perchè con i brevetti in scadenza sarebbe ora che i big si muovessero

domenicomic 03-08-10 17:39

snss la sunesina.................

legolego 03-08-10 17:41

CRXX e CXM :)

calopre 03-08-10 17:47

Citazione:

Originalmente inviato da domenicomic (Messaggio 26139115)
snss la sunesina.................

28 milioni e Voreloxin sviluppo fase tre
dove pensi possa arrivare?

legolego 03-08-10 17:48

dimenticavo...calopre...tu una volta non aggiornavi anche un tread interessantissimo sulle date di approvazione dei farmaci/pubblicazione studi? ... :) è da un po' che non lo vedo più..era interessantissimo!

calopre 03-08-10 17:53

Citazione:

Originalmente inviato da legolego (Messaggio 26139227)
dimenticavo...calopre...tu una volta non aggiornavi anche un tread interessantissimo sulle date di approvazione dei farmaci/pubblicazione studi? ... :) è da un po' che non lo vedo più..era interessantissimo!

vediamo di aggiornarci su questo di tread, magari una volta finito di ustionarsi al sole del salento. ciao

raggirays 03-08-10 17:55

attualmente in ptf:
SNSS
CPRX

erano in ptf:
PARD e CRXX, per ora le tengo d'occhio..

magari saranno in ptf:
SOMX (in osservazione strettissima :D.. appena leggo qualche articolo di ANALista che ne parla male entro)

Sal.Vi 03-08-10 18:06

La mia watch (ordine sparso):

AFFX, SQNM, CRXX, CGEN, INCY, BCRX, HSKA, VPHM, LMNX, ILMN, LIFE, ARQL, AEZS, KERX, AGEN, Staminal Cells

Citazione:

Originalmente inviato da calopre (Messaggio 26138840)
XOMA
NASDAQ LABOPHARM
NASDAQ ARYX THERAPEUTICS
NASDAQ ISTA PHARMACEUTICAL
NASDAQ LEXICON PHARMA
NASDAQ PONIARD PHARM
AMEX ULURU
manca exas da cui ancora una volta sono uscito per buon profitto e in attesa di rientrare
Praticamente vi propongo il mio portfolio sui titoli pharma
attendo di conoscere il vostro per un maggiore riscontro e conoscenza sui singoli titoli


domenicomic 03-08-10 18:12

Citazione:

Originalmente inviato da calopre (Messaggio 26139218)
28 milioni e Voreloxin sviluppo fase tre
dove pensi possa arrivare?

bhe' spero al $

domenicomic 03-08-10 18:13

SOMX (in osservazione strettissima .. appena leggo qualche articolo di ANALista che ne parla male entro) !!!!!!

buona tecnica.... da saggio indiano!augh

calopre 03-08-10 18:54

Citazione:

Originalmente inviato da domenicomic (Messaggio 26139519)
SOMX (in osservazione strettissima .. appena leggo qualche articolo di ANALista che ne parla male entro) !!!!!!

buona tecnica.... da saggio indiano!augh

Silenor per tutti

volgas 03-08-10 19:11

aryx rgn ulu acad anx enco.osci
rgn tb4 e uscita una news buona ieri, ma niente.

acad.. pimavanserin. parkinson fase2, alzheimer3, e scizofrenia3.

aryx. tercafarin e alla fine della fase2.avviso di delist il 22/11/2010

calopre 03-08-10 19:33

Citazione:

Originalmente inviato da volgas (Messaggio 26139973)
aryx rgn ulu acad anx enco.osci
rgn tb4 e uscita una news buona ieri, ma niente.

acad.. pimavanserin. parkinson fase2, alzheimer3, e scizofrenia3.

aryx. tercafarin e alla fine della fase2.avviso di delist il 22/11/2010

December 28, 2010, to regain compliance with the Rule. If, at any time before December 28, 2010, the market value of our publicly held shares closes at $15.0

s&d 03-08-10 20:43

Tra quelle che ho in portafoglio / tengo d'occhio le mie preferite sono:
AEZS, CXM, DDSS, BMOD, BIEL.
Per lo scalping intraday invece APCVZ anche se è un diritto e non un'azione.

aruba 03-08-10 22:38

salve a tutti,
io sono dentro in appa da 1,20. Avete qualche news o consiglio?

kyro 04-08-10 09:44

Portafoglio attuale:

CBMX - CombiMatrix Corporation
MELA - Mela Sciences, Inc.
PLX - Protalix BioTherapeutics, Inc.
GNVC - GenVec, Inc.
GNBT - Generex Biotechnology Corp.

calopre 04-08-10 16:36

[I]allora come vanno questi portafogli ?
non seguo gnbt da qualche tempo chi può dirmi qualcosa, mi sembra ora che parta altrimenti è meglio che si dedichi alle bibite

Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has now achieved 75% of the required number of per-protocol completers in its ongoing six month pivotal global Phase III study of Generex Oral-lyn(TM), the Company's proprietary buccal insulin spray product. These early results suggest that, should the current trend be maintained through the early 2011 completion date of the treatment phase of all enrolled subjects, the use of Generex Oral-lyn(TM) will support a non-inferiority claim relative to the standard-of-care injectable insulin. This position will be reviewed following a formal interim analysis after the 90-day results for all subjects become available.

vampeta9 04-08-10 16:46

SOMX da preapprovazione, uscito in gain in parte post approvazione... ora ancora dentro con pmc al prezzo attuale
NEXM perdo
XOMA oggi bene, ma in rosso generale
ARNA in deciso gain, pronto ad alleggerire in attesa

legolego 04-08-10 17:16

Qualcuno conosce/segue BIODEL? (BIOD) .....sale con volumi ....

calopre 04-08-10 19:11

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...

AtriCure (NASDAQ:ATRC) expects to file the final clinical module with the FDA for a Pre-Market Approval (PMA) submission during 1Q11 to support marketing clearance for its Isolator Synergy Bipolar Ablation System to re-establish normal heart rhythm in patients with atrial fibrillation (AF or a fib) based on the pivotal ABLATE clinical trial.

Cell Therapeutics (NASDAQ:CTIC) announced that it filed for a Special Protocol Assessment (SPA) agreement with the FDA for a new pivotal study in patients that failed first to third-line treatment and are not transplant eligible with relapsed or refractory aggressive B-Cell non-Hodgkin's lymphoma (NHL). CTIC expects to begin the pivotal study pending FDA feedback by year-end 2010 along with filing for European regulatory approval this year.

Below are summaries of the most recent articles written by Mark Messier at www.BioRunUp.com -- please visit his website to read the full articles, in addition to many other free tools and strategies related to binary event investing and trading...

Biodel (NASDAQ:BIOD) - 10/30/10 PDUFA for Diabetes Drug Heating Up

BIOD is another upcoming FDA play. It has a PDUFA date set for October 30th, 2010 for its diabetes drug VIAject. Let's take a look at Biodel, and its leading drug- VIAject. It looks to be an excellent candidate for trading using the Run-Up method. Biodel is taking advantage of what the FDA calls [...]

calopre 04-08-10 19:14

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...

Anadys Pharma (NASDAQ:ANDS) announced that six patients (100%) receiving 200mg twice daily of ANA598 (a direct-acting anti-viral agent against hepatitis C virus or HCV) maintained undetectable levels of HCV at 12-weeks post-treatment (Sustained Virological Response 12 or SVR12). Additional post-treatment results from other treatment arms in the ongoing Phase 2 study are expected later this year.

Bionovo (NASDAQ:BNVI) announced today that it received final guidance from the European Medicines Agency (EMA) for conducting a pivotal Phase 3 study of MENERBA for menopausal symptoms. In addition, BNVI has conducted a meeting with the FDA for the US development plan and will provide more details when the minutes from this meeting are released.

Below are summaries of the most recent articles written by Mark Messier at www.BioRunUp.com - please visit the site to read the full articles, in addition to many other free tools and strategies related to binary event investing...

Amarin Corp. (NASDAQ:AMRN) -- Clinical Trial with Upcoming Catalysts

Posted: 29 Jul 2010 02:38 AM PDT

I respect Mike Havrilla as a person, pharmacist, and trader, so when I found out that he expressed much confidence in a clinical trial, I wanted to learn more. I am passing this information on to my subscribers. I currently have no position in AMRN, but I am looking to open one after the October Run-Ups. For [...]

EXACT Sciences (NASDAQ:EXAS) Updates - Detection Technology Achieves 100% Sensitivity

Posted: 28 Jul 2010 07:38 AM PDT

This post is to update you on some recent developments and research done on EXAS. Clink on the title to read the article we published on Monday: "EXAS- Data Validation Study with a 10/29/10 Catalyst Date". Today, July 28th Exact Sciences reported their Q2 earnings. Some of the highlights include: Financial Information Exact reported total [...]

Below is a summary of my recent real-time trading updates posted yesterday on the BioRunUp.com Forum...

With the run-up in EXAS shares over past few days, none of my orders got filled so I decided to buy back into AMRN today with a little less money on the table (withdrew approx. $27K for non stock related investments)...I expect some cash to free up ahead of 29-Oct results for EXAS and may take a position on any pullbacks or just pile into AMRN over the next few months...

AMR101 (Ethyl-icosopentate or Ethyl-EPA) (Prescription-Grade Omega-3 Fatty Acid) -- Pivotal Phase 3 MARINE (NCT01047683), ANCHOR (NCT01047501) Clinical Trials under SPA (ClinTrials.gov IDs) (6-8 week run-in periods prior to the12-week treatment periods). AMRN is fully funded through a potential NDA filing with ongoing partner talks. My estimate for MARINE study to be fully randomized is 3Q10 (early AUG) and to complete the study by end OCT for potential results by year-end 2010 in DEC or early 2011. My estimate for the ANCHOR study to be fully randomized is during 4Q10 with potential results during 1-2Q11.

calopre 04-08-10 19:46

EXAS - Clinical Trial Results for ColoRectal Cancer Screen 10/29/10

ALRT - FDA 510(k) Filing for Health-e-Connect (HeC) System — Health Care for Diabetes Patients. ESTIMATED Date of 3/31/11

HOLX - FDA Advisory Panel for breast cancer screening / diagnosis on 9/24/10

AZN - FDA PDUFA for Brilinta 9/16/10

MKGAY - FDA Priority Review for Cladribine Tablets 12/8/10

calopre 05-08-10 09:40

iCad Inc. (Nasdaq: ICAD) Announced today that The U.S. Food and Drug Administration has given clearance to VeraLook, iCAD’s computer-aided detection product used in the interpretation of virtual colonoscopy exams. iCAD is an industry-leading provider of advanced image analysis solutions for the early detection of cancer.

"This breakthrough technology will aid radiologists in detecting and highlighting suspicious areas that could be missed during an initial review of a virtual colonoscopy exam," said Dr. Abraham Dachman, Professor of Radiology and Director of Fellowship Programs at the University of Chicago. "As with breast and prostate cancer detection, computer-aided detection for virtual colonoscopy will help us find more cancers at an earlier stage."

VeraLook from iCAD uses sophisticated interpretive technology to automatically identify polyps in images produced from a virtual colonoscopy, also known as CT colonography (CTC). A typical exam may contain between 1,200-1,500 images per patient. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.

Shares of iCad soared 17.71% or 34 cents to $2.26.

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that the U.S. Food and Drug Administration has designated XOMA 052, an antibody to interleukin-1 beta, an orphan drug for the treatment of Behcet's disease. As previously announced, the Committee for Orphan Medical Products of the European Medicines Agency has recommended the granting of orphan medicinal product designation for XOMA 052 for the same indication in the European Union.

Shares of XOMA jumped as much as 40% in early trading before paring back some of its gains and closing the day at 32 cents, up 15.48%.

NeoStem, Inc. (NYSE Amex: NBS) today announced that it has appointed Thomas Einhorn, M.D., Chairman of Orthopaedic Surgery at Boston University to its Medical Advisory Board. Thomas A. Einhorn, M.D. is Chairman of the Department of Orthopaedic Surgery and Professor of Orthopaedic Surgery, Biochemistry and Biomedical Engineering at Boston University. A graduate of Rutgers University and Cornell Medical College, he completed his internship at the Hospital of the University of Pennsylvania, orthopaedic residency at St. Luke's – Roosevelt Hospital in New York City, and a fellowship at the Hospital for Special Surgery. His professional focus is on the repair and regeneration of bone and cartilage using autologous adult stem cells, reconstructive surgery of the hip and knee, and the treatment of metabolic bone disease. He has authored over 200 peer-reviewed articles during his career to date.

Shares of NeoStem, which have been on a steady incline over the past couple of weeks, were up another 7.5% on the day.

NewCardio, Inc., (OTC Bulletin Board:NWCI.ob) announced today that, in collaboration with a leading global biopharmaceutical services provider that signed a Master Services Agreement (MSA) for the use of NewCardio's QTinno software solution earlier this year, the first revenue generating study has been completed.

NewCardio successfully installed QTinno at one of their Phase 1 units, enabling the sponsor to complete a small initial study. The data will provide an initial cardiac safety profile which can then be used to determine the next steps for the compound which could include further QT analysis or potential out-licensing of the compound. NewCardio expects to recognize the modest revenue from this study during the third quarter.

"The successful completion of this study, which satisfied all NewCardio's expectations for accuracy and timeliness, will facilitate the ongoing transition to more automated studies in the future," said Vincent Renz, NewCardio's President and Chief Operating Officer. "QTinno was implemented to help perform a small Phase 1 study rapidly and at low cost for their sponsor, providing useful data indicating the cardiac safety profile of the drug. We are excited to have achieved this milestone, and look forward to this leading to additional business with the biopharmaceutical services provider as well as this sponsor in the future."

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the second quarter and six months ended June 30, 2010 and provided an update on corporate developments.

"We made excellent progress during the second quarter on the ridaforolimus transition to our partner, Merck, which we expect to complete before the end of this year, and with preparations to initiate a global registration trial of AP24534, our investigational pan-BCR-ABL inhibitor, this fall," stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We are on track to achieve these goals and to drive and retain important shareholder value for our pipeline products."

CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has successfully produced and filled its first lot of Multikine® in preparation for the upcoming pivotal Phase III trial targeting advanced primary head and neck cancer.

The drug was filled in CEL-SCI’s state-of-the-art "Cold-Fill" manufacturing facility. The Company completed this test in order to ensure that it is able to produce significant quantities of Multikine to support the 880 patient clinical trial which is expected to commence prior to the end of the year. CEL-SCI's manufacturing facility, located outside of Baltimore, has been designed to fill biologics such as Multikine in true cold conditions (4 degrees Centigrade) which prevents/minimizes the loss of biological activity.

"Over the past few months, we have been highly focused on staffing and testing the facility in order to ensure that we have the equipment, resources and personnel to deliver Multikine to patients in the Phase III trial," said Geert Kersten, CEL-SCI's Chief Executive Officer. "We recognize that in a trial of this scale involving a biologic there are many precautions that we need to take, and we have made excellent progress in completing these tasks so we can begin the trial later this year. With a strong balance sheet, the new manufacturing facility, a global CRO in place and having Phase III partners Teva Pharmaceuticals and Orient Europharma, we are well positioned to take Multikine through this pivotal trial. We believe that Multikine represents a paradigm shift in the way cancer patients are treated."

Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced it has filed for a Special Protocol Assessment with the U.S. Food and Drug Administration for the design of its new phase III trial of pixantrone for patients with relapsed or refractory aggressive B-Cell non-Hodgkin's lymphoma ("NHL").

In the filing, CTI proposed to the FDA that the randomized study will compare pixantrone plus rituximab against the current standard regimens used to treat this patient group. This trial is planned to enroll relapsed or refractory aggressive B-Cell NHL patients who failed first-line to third-line treatment with standard chemotherapy and are not transplant eligible.

Cypress Bioscience, Inc. (NASDAQ:CYPB) today announced that it is discontinuing its rights under its agreement with Forest Laboratories to co-promote Savella®, its drug for fibromyalgia. Forest has agreed to pay Cypress a one-time payment of $2.0 million to help facilitate with this transition. Cypress will retain all other rights under its agreement with Forest including its royalty on Savella sales and may pursue the opportunity to re-activate the co-promotion right through discussions with Forest in the future. Forest will maintain promotional levels behind Savella.

In an effort to further reduce its cost structure, Cypress will also either discontinue or sell its personalized medicine services business by the end of Q3'2010. Cypress estimates that these actions will decrease its operating costs by approximately $10 million on an annualized basis. Operating results for the remainder of 2010 will be adversely affected by charges related to severance payments and termination of contractual obligations, which the company currently estimates will be approximately $3.5 million and up to approximately $1.0 million in impairment charges.

Additionally, Cypress will be decreasing its workforce by approximately 86% affecting 123 of its employees. Concurrent with this announcement, all affected employees will receive appropriate notice of the lay off to be effective October 6, 2010.

Penwest Pharmaceuticals Co. (Nasdaq:PPCO) surged more than 10% today after the company reported record financial results for the three and six months ended June 30, 2010. For the second quarter of 2010, revenues increased 159% year-over-year and total operating expenses decreased 28% year-over-year, leading to record net income of $8.4 million, or $0.26 per share.

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, announced that it has been added to the Russell Microcap® Index, following the Russell Investment Group’s annual reconstitution of its indices.

Also Wednesday:

legolego 05-08-10 11:37

wow! quanta carne al fuoco per questo autunno!
Ottime segnalazioni Calopre..grazie OK!

calopre 08-08-10 11:46

GenVec up on new agreement. Alphatec lowers outlook. FDA says no to Dusa Pharma PDF | Print | E-mail
Written by BioMedReports.com Staff
Friday, 06 August 2010 18:15
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Below is a list of the companies that made news in the healthcare sector on Friday, August 6, 2010.


GenVec, Inc. (Nasdaq:GNVC) today announced a new agreement for the supply of services relating to development materials with Novartis, related to the companies' collaboration in hearing loss and balance disorders. Under this new agreement, GenVec could receive approximately $13 million over four years to manufacture clinical trial material for up to two lead candidates.
"This contract supports our ongoing collaborative efforts with Novartis to uncover solutions to the unfortunate and widespread problems of hearing loss and balance disorders," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "This new agreement with Novartis will enable the manufacture of a potential product candidate to address this important unmet medical need." Preclinical results suggest that delivery of the atonal gene using GenVec's innovative adenovector technology may have the potential to restore hearing and balance function.

Shares of GenVec jumped nearly 12% in Friday trading, moving up 6 cents to $0.57.

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced Thursday after the bell financial results for the fiscal quarter ended June 30, 2010.

The company reported results that were below estimates and also lowered its revenue forecast. Alphatec cited, primarily due to pricing pressure, slower spinal device sales in the U.S. as well as in Europe.

Shares of Alphatec were nearly cut in half, dropping $2.03 or 45.93% to close Friday's trading at $2.39.

DUSA Pharmaceuticals, Inc. (Nasdaq:DUSA) reported today that on the afternoon of August 5, 2010 the U.S. Food and Drug Administration notified DUSA that it has not granted Orphan Drug Designation for the use of Levulan (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the prevention of cutaneous squamous cell carcinomas (SCCs) in patients who have a proven history of multiple localized cutaneous SCCs over a 12 month period. The FDA acknowledged that cutaneous SCC is a serious problem in patients at high risk for developing SCCs, such as solid organ transplant recipients (SOTRs), and that aminolevulinic acid would be a potential preventative therapy in these patients. However, the FDA also stated that they believe there are other factors which place patients at high risk of developing SCCs that should be included in determining the target population. To be eligible for Orphan Drug Designation, the drug must target a disease that affects fewer than 200,000 patients in the United States.

"We believe that we appropriately identified the target population and are disappointed that the FDA has declined to grant Levulan PDT Orphan Designation for this indication. DUSA feels that prevention of SCCs in this patient population would represent a significant advance in the management of these high risk patients," said Robert Doman, DUSA's President and Chief Executive Officer. "Without the regulatory protection and development opportunities that Orphan Drug Designation affords our resources are better utilized in other areas; therefore, we plan to close out our SOTR pilot clinical trial program over the next few months."

Shares of DUSA fell more than 9%, dropping 23 cents to $2.29.

Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that it has agreed to sell a total of 8,955,224 shares of its common stock, at a price of $6.70 per share, in a registered direct public offering to entities affiliated with Deerfield Management, a healthcare investment organization. Arena expects to receive gross proceeds, before expenses, of approximately $60 million.

In a seperate release, Arena, along with Eisai Inc. announced today that the US Food and Drug Administration has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

"Our primary objective at this time is to obtain FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "We have been preparing for this anticipated Advisory Committee meeting, and look forward to reviewing lorcaserin's profile with the panel members."

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that it has entered into definitive agreements to sell 1,351,352 shares of its common stock at a price per share of $1.11 pursuant to a registered direct offering to two large mutual funds, representing gross proceeds of $1.5 million.

The closing of the offering is expected to take place on August 9, 2010, subject to the satisfaction of customary closing conditions. Catalyst intends to use the proceeds from the offering for general corporate purposes.

The shares are being offered by Catalyst Pharmaceutical Partners, Inc. pursuant to a shelf registration statement filed with the Securities and Exchange Commission that was declared effective on June 26, 2008.

Patrick J. McEnany, Catalyst's Chief Executive Officer, said, "We expect that this financing will provide sufficient capital for Catalyst to operate into early 2012 and through the announcement of top-line results of our CPP-109 U.S. Phase II(b) cocaine trial."

Shares of Catalyst finished the day up 9 cents to $1.20, more than 8% higher than yesterdays close of $1.11.

Cypress Bioscience, Inc. (NASDAQ:CYPB), a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system disorders, today announced that its Board of Directors has unanimously concluded that the unsolicited, non-binding proposal by Ramius LLC to acquire all of the outstanding shares of Cypress common stock not owned by Ramius for $4.00 per share in cash grossly undervalues Cypress' current business and future prospects and consequently is not in the best interests of

calopre 08-08-10 11:58

I’ve been playing biotech heavily for the past 18 months. At this point, even if a company has cash EXPECT A DILUTION. The best thing to do is attempt to use it to your advantage.

Think about it from the companies point of view- Regardless of how confident they are in their product- the FDA is an unpredictable beast. They may request an additional trial, which costs millions and millions. Would ARNA/ALXA/BIOD/JAZZ rather get the cash now, just in case- or have to dilute three times as much because their share price tanked on a CRL / panel “No” vote?

In addition, if they do get approved, there are costs to get full scale manufacturing up and running.

SOMX diluted at $1.05 per share in July of 2009, months before it hit $10. Do not panic- as horrible as it is to pay $3 for a share and wake up to see it at $2.42 (ie: ALXA), it is part of the biotech game. In most cases, the run-up gets set back for a week or so, but then continues on. In recent memory, I can not think of a pre-catalyst dilution that has not continued to rise.

The point is- as much as dilutions suck, they are a necessary evil in the biotech market for the long term health and operation of the company. Use it to your advantage.

Related posts:

andreati 08-08-10 13:07

Citazione:

Originalmente inviato da calopre (Messaggio 26178870)
I’ve been playing biotech heavily for the past 18 months. At this point, even if a company has cash EXPECT A DILUTION. The best thing to do is attempt to use it to your advantage.

Think about it from the companies point of view- Regardless of how confident they are in their product- the FDA is an unpredictable beast. They may request an additional trial, which costs millions and millions. Would ARNA/ALXA/BIOD/JAZZ rather get the cash now, just in case- or have to dilute three times as much because their share price tanked on a CRL / panel “No” vote?

In addition, if they do get approved, there are costs to get full scale manufacturing up and running.

SOMX diluted at $1.05 per share in July of 2009, months before it hit $10. Do not panic- as horrible as it is to pay $3 for a share and wake up to see it at $2.42 (ie: ALXA), it is part of the biotech game. In most cases, the run-up gets set back for a week or so, but then continues on. In recent memory, I can not think of a pre-catalyst dilution that has not continued to rise.

The point is- as much as dilutions suck, they are a necessary evil in the biotech market for the long term health and operation of the company. Use it to your advantage.

Related posts:

La posizione che ho sul settore pharma riguarda il long term su CXm, DDSS,SOMX ed HEB.
E propio su HEB Calopre se puoi volevo sapere il tuo pensiero sul titolo alla luce della trim di venerdi scorso e sul loro farmaco Ampligen visto che sono trasscorsi ormai i sei mesi che la FDA aveva richiesto come ulteriori test di sicurezza.
La società ha una discreto liquidità e ha ottime prospettive anche in Giappone ed i test finora sembrerebbero positivi sulla patologia CFS.
Saluti.

calopre 08-08-10 13:40

GenVec up on new agreement. Alphatec lowers outlook. FDA says no to Dusa Pharma PDF | Print | E-mail
Written by BioMedReports.com Staff
Friday, 06 August 2010 18:15
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Below is a list of the companies that made news in the healthcare sector on Friday, August 6, 2010.


GenVec, Inc. (Nasdaq:GNVC) today announced a new agreement for the supply of services relating to development materials with Novartis, related to the companies' collaboration in hearing loss and balance disorders. Under this new agreement, GenVec could receive approximately $13 million over four years to manufacture clinical trial material for up to two lead candidates.
"This contract supports our ongoing collaborative efforts with Novartis to uncover solutions to the unfortunate and widespread problems of hearing loss and balance disorders," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "This new agreement with Novartis will enable the manufacture of a potential product candidate to address this important unmet medical need." Preclinical results suggest that delivery of the atonal gene using GenVec's innovative adenovector technology may have the potential to restore hearing and balance function.

Shares of GenVec jumped nearly 12% in Friday trading, moving up 6 cents to $0.57.

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced Thursday after the bell financial results for the fiscal quarter ended June 30, 2010.

The company reported results that were below estimates and also lowered its revenue forecast. Alphatec cited, primarily due to pricing pressure, slower spinal device sales in the U.S. as well as in Europe.

Shares of Alphatec were nearly cut in half, dropping $2.03 or 45.93% to close Friday's trading at $2.39.

DUSA Pharmaceuticals, Inc. (Nasdaq:DUSA) reported today that on the afternoon of August 5, 2010 the U.S. Food and Drug Administration notified DUSA that it has not granted Orphan Drug Designation for the use of Levulan (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the prevention of cutaneous squamous cell carcinomas (SCCs) in patients who have a proven history of multiple localized cutaneous SCCs over a 12 month period. The FDA acknowledged that cutaneous SCC is a serious problem in patients at high risk for developing SCCs, such as solid organ transplant recipients (SOTRs), and that aminolevulinic acid would be a potential preventative therapy in these patients. However, the FDA also stated that they believe there are other factors which place patients at high risk of developing SCCs that should be included in determining the target population. To be eligible for Orphan Drug Designation, the drug must target a disease that affects fewer than 200,000 patients in the United States.

"We believe that we appropriately identified the target population and are disappointed that the FDA has declined to grant Levulan PDT Orphan Designation for this indication. DUSA feels that prevention of SCCs in this patient population would represent a significant advance in the management of these high risk patients," said Robert Doman, DUSA's President and Chief Executive Officer. "Without the regulatory protection and development opportunities that Orphan Drug Designation affords our resources are better utilized in other areas; therefore, we plan to close out our SOTR pilot clinical trial program over the next few months."

Shares of DUSA fell more than 9%, dropping 23 cents to $2.29.

Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that it has agreed to sell a total of 8,955,224 shares of its common stock, at a price of $6.70 per share, in a registered direct public offering to entities affiliated with Deerfield Management, a healthcare investment organization. Arena expects to receive gross proceeds, before expenses, of approximately $60 million.

In a seperate release, Arena, along with Eisai Inc. announced today that the US Food and Drug Administration has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

"Our primary objective at this time is to obtain FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "We have been preparing for this anticipated Advisory Committee meeting, and look forward to reviewing lorcaserin's profile with the panel members."

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that it has entered into definitive agreements to sell 1,351,352 shares of its common stock at a price per share of $1.11 pursuant to a registered direct offering to two large mutual funds, representing gross proceeds of $1.5 million.

The closing of the offering is expected to take place on August 9, 2010, subject to the satisfaction of customary closing conditions. Catalyst intends to use the proceeds from the offering for general corporate purposes.

The shares are being offered by Catalyst Pharmaceutical Partners, Inc. pursuant to a shelf registration statement filed with the Securities and Exchange Commission that was declared effective on June 26, 2008.

Patrick J. McEnany, Catalyst's Chief Executive Officer, said, "We expect that this financing will provide sufficient capital for Catalyst to operate into early 2012 and through the announcement of top-line results of our CPP-109 U.S. Phase II(b) cocaine trial."

Shares of Catalyst finished the day up 9 cents to $1.20, more than 8% higher than yesterdays close of $1.11.

Cypress Bioscience, Inc. (NASDAQ:CYPB), a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system disorders, today announced that its Board of Directors has unanimously concluded that the unsolicited, non-binding proposal by Ramius LLC to acquire all of the outstanding shares of Cypress common stock not owned by Ramius for $4.00 per share in cash grossly undervalues Cypress' current business and future prospects and consequently is not in the best interests of Cypress' other stockholders.

Lannett Company, Inc. (AMEX: LCI), a manufacturer of generic pharmaceuticals, announced today that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Ondansetron Injection, USP, 2 mg/mL, Single-Dose Vials. Ondansetron Injection, USP, 2 mg/mL is the generic version of GlaxoSmithKline’s Zofran Injection, 2 mg/mL. For the 12 months ending December 2009, Ondansetron Injection, USP, 2 mg/mL had U.S. sales of approximately $58 million at Average Wholesale Price. A launch date for the product has not been set.

"Ondansetron Injection is another product coming out of our joint venture with Wintac Ltd. and the second injectable product for which we filed an ANDA and received FDA approval," said Arthur Bedrosian, president and chief executive officer of Lannett. "The additional dosage form broadens our product offering and builds our presence in the injectable market."

Ondansetron Injection, USP, 2 mg/mL is indicated for the prevention of postoperative nausea and vomiting and for the prevention of chemotherapy-induced nausea and vomiting.

The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Patent and Trademark Office (PTO) has granted a one-year interim extension of the term of U.S. Patent No. 5,196,404, the principal U.S. patent that covers Angiomax, until August 13, 2011.

The PTO routinely grants such interim extensions when required to provide time to process innovators' applications for patent term extension under the Hatch Waxman Act.

The Company expects the new patent expiry date to be listed in the FDA "Orange Book."

Also Friday:


ADVENTRX Pharmaceuticals, Inc. (NYSE Amex:ANX) today reported financial results for the three and six months ended June 30, 2010.

Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) announced today that company Senior Vice President and Chief Financial Officer, August J. Moretti will present during the Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference.

AspenBio Pharma, Inc. (NASDAQ: APPY), has been invited to present at the Canaccord Genuity 30th Annual Growth Conference.

Ardea Biosciences, Inc. (Nasdaq:RDEA), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases, today reported recent accomplishments and financial results for the second quarter and six months ended June 30, 2010.

BioElectronics Corporation (PINKSHEETS: BIEL), developers of innovative pain-relieving medical devices, announces today an expansion in their Direct Response Television (DRTV) efforts to United Kingdom (UK) and Canada.

BioSpecifics Technologies Corp. (Nasdaq:BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the second quarter ended June 30, 2010.

Endo Pharmaceuticals (Nasdaq:ENDP) today announced that it will present at the Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference on Thursday, August 12, 2010, at 8:00 a.m. EDT.

Exelixis, Inc. (NASDAQ:EXEL) announced today that Charles Butler, the company's vice president of investor relations and corporate communications, will present at the Canaccord Genuity 30th Annual Growth Conference at 10:30 a.m. EDT / 7:30 a.m. PDT on Thursday, August 12, 2010 in Boston.

Helix BioMedix, Inc. (OTCBB: HXBM), a developer of bioactive peptides, today announced financial results for the company's second quarter 2010 ended June 30, 2010.

iCAD, Inc. (NASDAQ: ICAD), an industry-leading provider of advanced image analysis and workflow solutions for the early identification of cancer, today announced that Ken Ferry, President and Chief Executive Officer and Darlene Deptula-Hicks, Executive Vice President and Chief Financial Officer, are scheduled to present a corporate overview at the Canaccord Genuity 30th Annual Global Growth Conference on Tuesday, August 10, 2010 at 11:00 a.m. (EDT) at the InterContinental Hotel in Boston.

Medtronic, Inc. (NYSE: MDT), today announced that it has completed enrollment in a clinical t ial of the company's Complete SE (self-expanding) vascular stent for the treatment of atherosclerosis in the superficial femoral artery (SFA), including the proximal popliteal artery (PPA), which runs under the skin of the thigh.

Novavax, Inc. (Nasdaq:NVAX) today announced financial results for the second quarter ended June 30, 2010.

NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders, today announced the pricing of its initial public offering of 5,000,000 shares of its common stock at $10.00 per share, before underwriting discounts and commissions.

Orexigen Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the Company will be speaking at the Canaccord Genuity Global Growth Conference.

Osiris Therapeutics, Inc. (NASDAQ:OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in the inflammator, autoimmune, cardiovascular and orthopedic areas, announced today its results for the second quarter of fiscal 2010.


per HEB tempi troppo lunghi, è sempre ad un passo dall'obiettivo e non ci arriva mai.
anche i manager incidono sui risultati, io lasciai somx troppo presto perchè ha un manager troppo spocchioso ma i suoi risultati li porta a casa, quello di heb segue Bianco
tanto movimento pochi risultati. per il resto non so perchè non seguo Heb da un anno. a risentirci.

jellino 09-08-10 07:28

ciao calopre cosa pensi di : Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS
grazie :bow:

calopre 09-08-10 10:11

Citazione:

Originalmente inviato da jellino (Messaggio 26181605)
ciao calopre cosa pensi di : Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS
grazie :bow:

Sunesis Pharmaceuticals Appoints Steering Committee and Clinical Partners for Vosaroxin Pivotal Phase 3 Trial in AML PDF | Print | E-mail
Wednesday, 04 August 2010 02:01
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SOUTH SAN FRANCISCO, CA--(Marketwire - August 4, 2010) - Sunesis Pharmaceuticals, Inc. (NASDAQ: Ticker=SNSS">SNSS) today announced the Steering Committee and other clinical trial partners for its pivotal Phase 3 trial of vosaroxin in acute myeloid leukemia (AML).Sunesis also announced that it requested, and that the United States Adopted Names (USAN) Council has accepted the new nonproprietary name "vosaroxin" for its lead drug candidate (formerly known as voreloxin).The USAN Council aims for global standardization and unification of drug nomenclature and related rules to ensure that drug information is communicated accurately and unambiguously.

The Phase 3 trial, known as VALOR (Vosaroxin and Ara-C combination evaLuating Overall survival in Relapsed/refractory AML), is a multinational, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine in 450 patients with first relapsed or primary refractory AML.It is expected to begin enrollment later this year.

"We have made important progress toward ensuring that our pivotal Phase 3 AML trial is a well-executed study, and continue to work diligently toward ensuring its timely launch," said Daniel Swisher, Sunesis' Chief Executive Officer."Our internal clinical leadership, which includes individuals with extensive late-stage development experience, is now supplemented by clinical partners and a Steering Committee with significant, international hematology experience. We are in the process of compiling and finalizing the documentation needed for local regulatory authority and ethics committee submissions, and we remain on track to initiate the VALOR trial later this year."

"Refractory and relapsed AML are disease settings for which there is an enduring unmet medical need.Currently no Phase 3 trial is enrolling both first relapsed or primary refractory AML patients," said Eric Feldman, MD, Chair of the VALOR Steering Committee and Professor of Medicine and Director of the Leukemia Program and Hematological Malignancies at Weill Cornell Medical College."The VALOR trial is a rigorously designed study which will provide randomized data assessing the potential incremental contribution of vosaroxin to underlying cytarabine therapy in relapsed or refractory AML, with overall survival serving as the primary endpoint.I look forward to the initiation of this trial and to serving as a member of its Steering Committee."

The Steering Committee will provide scientific oversight for the VALOR trial as well as communicate its recommendations regarding trial conduct with the trial's Data Safety Monitoring Board and Sunesis. Steering Committee members are:

Eric Feldman, MD, Chair of Steering Committee, Professor of Medicine and Director of the Leukemia Program and Hematological Malignancies at Weill Cornell Medical College Harry Erba, MD, PhD, Associate Professor, Department of Internal Medicine at the University of Michigan and Executive Officer of the Southwest Oncology Group Gary Schiller, MD, Professor of Medicine, Director of the Hemapherisis Unit and Chairman of the Medical Specialties College of the David Geffen School of Medicine at the University of California, Los Angeles Robert Stuart, MD, founding director of the Aplastic Anemia & Myelodysplastic Syndrome Foundation, Director of the clinical component of the Hollings Cancer Center's Hematological Malignancies Program and Medical Director of the Clinical Trials Office at the University of South Carolina Norbert Vey, MD, Professor of Medicine, Leukemia and MDS Unit, Department of Hematology at the Institut Paoli-Calmettes, Marseille, France
Among the clinical trial partners appointed by Sunesis are (i) ICON, a contract research organization with global capabilities, hematology expertise and extensive Phase 3 experience; (ii) Catalent Pharma Solutions, a leading global provider of advanced technologies, and development, clinical, manufacturing and packaging services, including global comparator procurement, secondary packaging and logistics; and (iii) Cytel, a highly regarded statistical services provider. Sunesis has also retained the Clinical Development Group, LLC to augment Sunesis' Phase 3 strategic development support for the VALOR trial, including clinical site management and patient recruitment.Key individuals from the Clinical Development Group have recent, multinational Phase 3 AML trial experience, including Ann Cahill, formerly the Vice President of Clinical Development at Vion Pharmaceuticals.

calopre 09-08-10 10:16

Labopharm on the Rebound? PDF | Print | E-mail
Written by Vinny Cassano
Saturday, 31 July 2010 14:27
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It's been a little while since I last reminded readers not to forget about Labopharm, and as I emphasize this point again, it's quite possible that DDSS may already be on the rebound.

Shares of Labopharm significantly declined after the company received FDA approval in February for OLEPTRO, a once-daily formulation of Trazodone intended to treat Major Depressive Disorder (MDD).

After a pre-approval runup, the stock has since traded for as low as eighty cents, reaching that mark barely a month ago. The drop in price and the lull in news opened up a fine opportunity for investors with a mid to long term outlook to load up on shares, and that patience may now be starting to pay off as the price action over the past couple of weeks indicates that a rebound may be in effect.


LABOPHARM
1.15 +0.06 (+5.50%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.Labopharm closed the week last week at $1.16, near the high for the week - possibly in anticipation of a decision from the Canadian medical regulatory authorities who on August 4th are expected to rule on OLEPTRO approval. If OLEPTRO is approved in Canada, a likely scenario in my opinion, another market opens up for the product providing additional long term value for the stock.

However, we saw what happened to DDSS after US approval, so it would be foolish to assume that the share price would increase based on that news alone.

It's also possible that the sudden uptick is related to the pending commercial launch of OLEPTRO in the United States, as it's long been projected that the Labopharm Angelini joint venture would launch the product in the third quarter of this year.

News of product launch in the US combined with any positive news from Canada could be enough to immediately spike the price of the stock, although I believe that it will only be solid sales numbers further on down the road that can keep the share price trading significantly higher without the volatility. The antidepressive market is a huge one - over $10 billion annually - so it's certainly possible that OLEPTRO sales will eventually annually surpass the current market cap of Labopharm.

Of course, that depends a lot on how well the product is accepted and how well it is marketed.

Labopharm also has a once-daily version of Tramadol to treat moderate to severe pain already on the market globally and the potential for sales growth for that product is fairly significant being that it is available in nineteen countries.

A twice-daily combination version of Tramadol and acetaminophen is also being prepared for regulatory filings in Europe, Canada and the United States while a twice-daily version of acetaminophen alone is in earlier stages of development.

I thought investors were getting a great deal in terms of risk/reward while DDSS was trading for right around a buck, and depending on what transpires on Monday and Tuesday, it may not be too late to add.

As always, no matter how promising a company's future looks, there's no sure things in the stock market; therefore, I always suggest flipping a few shares into any nice spikes in price in order to end up on 'house money' as quickly as possible.

I do like the prospects for Labopharm and, if nothing else, DDSS is a stock to watch right now. In a couple of years down the road we could be looking back at these prices wondering why didn't buy more.

Disclosure: Long DDSS.


è del 31 luglio ma valida ancora

calopre 09-08-10 12:45

ARYX: Sink or Swim? PDF | Print | E-mail
Written by Patrick Crutcher
Monday, 09 August 2010 04:40
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ARYx Therapeutics Inc.(NASDAQ: ARYX) has been slowly drifting downward and appears to have reached a more stable bottom. They are an interesting small-cap biotech with 3 mid-stage drugs that will be ready for Phase 3 trials in the coming months. Only problem is that ARYX has dwindling cash reserves that most certainly will not cover the costs of these trials.

With these problems in mind, in February 2010, ARYX sought out Cowen and Co. to “to explore strategic options for ARYX. By retaining Cowen, ARYx will explore the possibility of capturing full near-term value for its three lead programs rather than pursuing licensing deals that provide value over an extended period of time.”

Clearly, they couldn’t find a deal that they could live off of from budiodarone. So ARYX has decided to hang up the “For Sale” sign and see what they can get. ARYX does have assets which some larger pharmaceutical could continue to develop. They have several promising drugs that are going into Phase 3. Below is a brief description of their drugs.

ARYX THERAPEUTICS
0.46 -0.03 (-6.33%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.In particular, Budiodarone has blockbuster potential. Budiodarone is an oral anti-arrhythmic agent in Phase 2b clinical development for the treatment of patients with atrial fibrillation. Atrial fibbralation affects more than 6.4 million people in the United States, Europe and Japan. It is estimated that AFIB is responsible for more than 75,000 strokes per year in the United States alone. Their Phase 2b study showed great promise and appears to be the main target in any acquistion.

ATI-7505 is an oral prokinetic drug that has successfully completed Phase 2 clinical trials for the treatment of multiple gastrointestinal disorders including chronic idiopathic constipation, gastroesophageal reflux disease, or GERD, and functional dyspepsia. It was initially partnered with P&G for full rights and returned to ARYx when P&G exited pharmaceutical development. Again, this appears to be a very promising drug that has proven to be successful in clinical trials and covers roughly 100M patients. Tecarfarin is an oral anticoagulant for the treatment of patients who are at risk for the formation of dangerous blood clots. Unfortunately, tecarfarin would face very stiff competition if developed, especially with MNTA’s generic Lovenox and TEVA’s generic on the horizon.

In May, they updated the investors with a tease when they said, “The company believes that the work with Cowen has progressed well in the last 10 weeks and has generated interest which could result in partnerships on one or more of the three lead product candidates, the sale of ARYx's assets, in whole or in part, or some similar arrangement through which the value of ARYx's assets to stockholders could be optimized.”

They also reiterated that they only have enough cash left to “operate into September 2010, by which time the company expects to have indications about the results of the current strategic process with Cowen. ARYx is also actively pursuing other options for continued funding beyond September 2010, if required.”

This is a tricky situation for investors who might like to cash-in on ARYX if they were to be acquired. Their acquisition could be done on the cheap, since they only have 33M shares and at this point have little leverage in any negotiations. For $33M - $66M ($1 - $2 pps), they could get access to 2 drugs in large markets(ignoring tecarfarin), which seems reasonable based on how much of the developmental work has been completed and market potential. However, investors shouldn’t ignore the possibility that ARYX is on the verge of running out of cash without successfully coming to terms with a buyer. This is a serious risk. Tho

jellino 09-08-10 13:07

[Quote = calopre ; 26182521 ] Sunesis Pharmaceuticals nomina del Comitato direttivo e partner per la fase clinica 3 Vosaroxin Pivotal Trial nella LAM PDF | Stampa | E-mail
Mercoledì 4 agosto 2010 02:01
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South San Francisco , CA - (Marketwire - 4 agosto 2010 ) - Sunesis Pharmaceuticals , Inc. ( NASDAQ: Ticker SNSS = "> SNSS ) ha annunciato oggi il comitato direttivo e di altri partner per la sua sperimentazione clinica di Fase centrale di prova di tre vosaroxin in la leucemia mieloide acuta (LMA ). Sunesis ha anche annunciato che ha chiesto , e che gli Stati Uniti denominazioni adottate ( USAN ) Consiglio ha accettato il nuovo nome non proprietario " vosaroxin "per il suo candidato farmaco piombo (precedentemente noto come voreloxin ). Il Consiglio intende USAN globale per la standardizzazione e unificazione della nomenclatura di droga e le relative norme per garantire che le informazioni siano comunicate di droga in modo accurato e non ambiguo.

L' studio di Fase 3 , noto come Valor ( Vosaroxin e Ara-C combinazione valutare la sopravvivenza complessiva in recidivante / refrattario AML) , è una multinazionale , randomizzato , in doppio cieco , controllati con placebo, studio registrativo vosaroxin in combinazione con citarabina in 450 pazienti con la prima AML.It recidivante o refrattario primaria dovrebbero iniziare entro la fine dell'anno di iscrizione .

"Abbiamo fatto progressi importanti verso assicurare che la nostra chiave di Fase 3 trial AML è uno studio ben eseguito , e continuare a lavorare diligentemente per garantire il suo tempestivo avvio ", ha detto Daniel Swisher , Sunesis ' Amministratore Delegato. "La nostra leadership interna clinica, che comprende gli individui con una vasta esperienza di sviluppo in ritardo-fase , è ora integrata da partners clinici e un comitato direttivo con una significativa esperienza internazionale di ematologia . Siamo nel processo di raccolta e messa a punto la documentazione necessaria per le locali autorità di regolamentazione e le osservazioni del comitato etico , e restiamo sulla strada giusta per avviare il processo VALOR entro la fine dell'anno . "

"Refrattario e recidivante AML sono le impostazioni malattia per la quale vi è un duraturo medica insoddisfatta need.Currently nessun studio di Fase 3 è di iscriversi sia al primo pazienti con malattia refrattaria o recidivante primario AML, "ha detto Eric Feldman , MD, presidente del comitato direttivo VALOR e Professore di Medicina e Direttore del Programma di leucemia e neoplasie ematologiche presso il Weill Cornell Medical College. "Il processo VALOR è uno studio rigorosamente progettato, che dovranno fornire i dati randomizzati valutazione del contributo potenziale incrementale di citarabina vosaroxin alla terapia di fondo in LMA recidivante o refrattario , con la sopravvivenza globale nella sua funzione di primario endpoint.I vediamo l'ora di inizio del processo e di servire come un membro del suo Comitato direttivo . "

Il Comitato Direttivo fornirà supervisione scientifica per la sperimentazione VALOR e di trasmettere le proprie raccomandazioni in materia di condotta prova con Monitoring Board dello studio di dati di sicurezza e Sunesis . I membri del comitato direttivo sono:

Eric Feldman , MD , Presidente del Comitato Direttivo, Professore di Medicina e Direttore del Programma di leucemia e neoplasie ematologiche al Weill Cornell Medical College di Erba Harry , MD , PhD, Professore Associato, Dipartimento di Medicina Interna presso l'Università del Michigan e delegato di la Southwest Oncology Group Gary Schiller , MD, Professore di Medicina , Direttore della Unità Hemapherisis e presidente del Medical College Specialità della David Geffen School of Medicine presso la University of California, Los Angeles Robert Stuart , MD, direttore fondatore del aplastica Anemia e sindrome mielodisplastica Foundation, direttore della componente clinica della Hollings Cancer Center Ematologiche Neoplasie Programma e direttore medico della sperimentazione clinica di Office presso la University of South Carolina Norbert Vey , MD, Professore di Medicina , la leucemia e sindrome mielodisplastica Unit , Dipartimento di Ematologia presso l'Institut Paoli - Calmettes , Marsiglia, Francia
Tra i partner di studio clinico nominato dalla Sunesis sono (i) ICON , un'organizzazione di ricerca a contratto con le capacità globali , la competenza ematologia e di fase 3 vasta esperienza , (ii) Catalent Pharma Solutions , fornitore leader mondiale di tecnologie avanzate, e sviluppo, clinica, produzione e confezionamento , compresi gli appalti di confronto a livello mondiale , l'imballaggio secondario e logistica, e (iii) Cytel , un apprezzato fornitore di servizi statistici . Sunesis ha anche mantenuto il Clinical Development Group , LLC per aumentare la Fase Sunesis '3 supporto strategico di sviluppo per il processo VALOR , compresa la gestione dei siti clinici e pazienti da individui recruitment.Key lo sviluppo clinico del gruppo hanno più recenti, multinazionale di fase 3 esperienza prova AML , tra cui Ann Cahill , già Vice Presidente Sviluppo Clinico presso Pharmaceuticals Vion . [/ QUOTE]

NON MI HAI FATTO UN TUO COMMENTO E PREVISIONE SUL TITOLO:no:

calopre 09-08-10 14:24

quì si scommette tutto su un prodotto farmaceutico di difficile realizzazione e comunque con una previsione di tempi lunghissima. se credi nel successo del pharma vale la pena restare dentro altrimenti .............?.

calopre 10-08-10 16:57

aggiornamento portafoglio
NASDAQ LABOPHARM
NASDAQ PONIARD PHARM
AMEX ULURU
entra ALXA

calopre 11-08-10 11:06

Poniard has focused its resources on optimizing the picoplatin value proposition and realizing this value for our shareholders through a strategic transaction," said Ronald Martell, chief executive officer of Poniard. "While we engage in active and ongoing dialogue regarding potential strategic alternatives, we are continuing to maintain picoplatin's visibility within the medical community, most recently through the presentation of the final data from our Phase 3 SPEAR trial, which showed that picoplatin is an active compound with the potential to address a key unmet medical need in second-line small cell lung cancer."
ristrutturandosi arriva a fine anno, ma se non trovano un amatore con un finanziamento ad hoc sarà come ieri o peggio.
dispiace perchè di fatto siamo in presenza di pipeline di alto livello.
farà gola a qualcuno?
ho inserito in portafoglio di nuovo xoma

calopre 11-08-10 20:18

Possible Genzyme Buyout Could Spike Small Cap Bio (NASDAQ:GENZ) (NASDAQ:PARD) (NASDAQ:THLD) (NASDAQ:OXGN) (AMEX:ULU) By Gareth Soloway on July 26th, 2010 12:26pm Eastern Time
Rumors are swirling around a possible buyout of Genzyme Corporation (NASDAQ:GENZ) by Sanofi-Aventis SA (NYSE:SNY). Since Friday, Genzyme has jumped from $54.00 per share to a high today of $67.69. As buyout frenzy hits Wall Street and specifically biotechs, small cap dead bottom biotechs may get some play.

One of these dead bottom plays are Poniard Pharmaceuticals, Inc. (NASDAQ:PARD), which is trading near its 52 week lows and below cash. In addition it was voted best of the ASCO conference. Other interesting micro cap plays trading near their lows are Threshold Pharmaceuticals, Inc. (NASDAQ:THLD), OXiGENE, Inc. (NASDAQ:OXGN) and Uluru Inc. (AMEX:ULU). Keep a close eye on these in the coming days. Some are upticking today already.

With a buyout of Genzyme looming, it may also signal that many large companies sitting on massive amounts of cash may be looking to spend it. This may mean other stocks in other sectors, trading on their dead bottoms could bounce. Stay tuned to this interesting story on Genzyme. I am on small cap bio alert at this point, watching for anything of interest.

Notizia vecchia ma più che mai attuale ed è forse l'unica salvezza per queste micro bio
che stanno lontano dalla fda anni luce.
ora è vero che un passaggio di un farmaco da una fase all'altra crea un pò di euforia ma ormai la stragrande maggioranza di queste bio non hanno i denari neppure per pagarsi un capanno nel deserto.quindi occhio alla qualità dei farmaci.

Claudiano 11-08-10 21:04

Citazione:

Originalmente inviato da calopre (Messaggio 26206724)
ma ormai la stragrande maggioranza di queste bio non hanno i denari neppure per pagarsi un capanno nel deserto.quindi occhio alla qualità dei farmaci.

BRAVISSIMO. Si chiamano bio-crosteOK!

calopre 12-08-10 13:33

Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) announced today that, based on recent discussions with its development partner Merck (NYSE: MRK), the next phase of the clinical program for vernakalant (oral) is not expected to commence in the summer of 2010 as previously guided. Merck continues to work toward optimizing the clinical development plan for vernakalant (oral), and Cardiome will provide updated guidance when Merck has finalized their planning.

The company also reported weaker than expected 2nd quarter results with revenue of $12.4 million being lower than analyst expectations of $16.4 million.

Shares of Cardiome fell more than 13% or $1.17, ending Wednesdays trading session at $7.73.

Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced the US Patent and Trademark office has issued U.S. Patent No. 7,759,360 for Androxal, the Company’s lead program for the treatment of low testosterone in men. This patent specifically claims methods and materials for the treatment of testosterone deficiency in men with secondary hypogonadism. Repros has over 35 issued or pending US and European patents involving Androxal. The term of the patent will expire on March 19, 2023. If a Patent Term Extension under the Hatch-Waxman Act is granted, patent life in the US could extend into 2028.

"We are pleased to strengthen our intellectual property portfolio and expect additional patent grants surrounding Androxal," stated Joseph Podolski, President and Chief Executive Officer of Repros Therapeutics. "This patent is important to the protection of our Androxal program. If Repros can successfully develop Androxal, it could become a leading treatment for low testosterone in men."

Androxal is an oral therapy that restores testicular function in men experiencing low testosterone due to secondary hypogonadism. Secondary hypogonadism is a condition commonly related to aging but may result or be a co morbid state associated with a variety of conditions, including Type II diabetes. Secondary hypogonadism is not a failure of the testes, but an inability of the pituitary to respond to a low testosterone state by secreting sufficient levels of luteinizing hormone (LH) to adequately stimulate the testes. Androxal stimulates the pituitary to secret normal levels of important testicular stimulating pituitary hormones.

Shares of Repros rose 9.26% on nearly triple the average daily volume.

Advaxis, Inc (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company and Vibalogics GmbH, a German biologics manufacturing company, have agreed to co-develop a room temperature stable, processing technology for live vaccines originally engineered for Advaxis.

Most live vaccines are stored via freeze drying called lyophilization. This drying method may not be suitable for all products, as it frequently kills most of the microorganism; depending upon the organism type and related recovery and stability issues. Based on Vibalogics’ drying experience, a new method has been found that allows for a room temperature, storage-stable form of Advaxis’ live Listeria vaccines with a very high recovery.

"This process, which we are currently developing for our Listeria immunotherapeutics, shows promise in its use with other living micro-organisms," commented Advaxis Chairman/CEO Thomas A. Moore. "Although it is intended for use with Listeria, other companies and academic institutions that use living microorganisms (e.g., Salmonella, E. coli) may benefit from this process. This initiative does not require significant development funds from Advaxis, vastly increases the commercial properties of our products, and can increase our short- and long-term shareholder value."

Shares of Advaxis rose more than 18% on the news.

Amgen (Nasdaq:AMGN) today announced top-line results from a randomized Phase 3 trial evaluating Vectibix (panitumumab) as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer. The data showed the addition of Vectibix to platinum-based chemotherapy did not result in a statistically significant improvement in overall survival, the primary endpoint, compared to chemotherapy alone. Therefore, the study did not meet its primary endpoint. Secondary endpoints of progression-free survival [median 5.8 months versus 4.6 months], and objective response rate (36 percent versus 25 percent) were numerically improved but were not tested for statistical significance.

"The outcome of this study is disappointing. However, Vectibix remains an important monotherapy treatment option for patients with metastatic colorectal cancer whose disease has progressed on other therapies," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.

CardioNet, Inc. (NASDAQ:BEAT), a leading wireless medical technology company with a current focus on the diagnosis and monitoring of cardiac arrhythmias, announced today that on August 10, 2010, the United States District Court for the Eastern District of Pennsylvania granted the Company’s motion to dismiss the securities class action litigation filed in August 2009 against the Company and certain of its former officers.

Joe Capper, President and Chief Executive Officer, stated, "We are pleased with the Court’s ruling and believe that the facts in the case clearly supported the Company’s position."

Depomed, Inc. (Nasdaq:DEPO) announced today that it has reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment (SPA) on the design and analysis of Breeze 3, a Phase 3 trial evaluating Serada for menopausal hot flashes.

Depomed is initiating Breeze 3 immediately as clinical sites are all on line with more than 200 patients in the screening process already. Breeze 3 is expected to be completed by the end of the third quarter of 2011, with results to be reported in the fourth quarter.

"We believe that Breeze 3 will be successful based on the new refined trial design which is expected to accurately measure Serada's drug effect, and result in a placebo effect between 45% to 55%, as seen in other published hot flash trials," said Michael Sweeney, M.D., Depomed's vice president, Research and Development.

Carl A. Pelzel, president and chief executive officer of Depomed, added, "We are pleased to reach an SPA agreement with the FDA, and advance this important product candidate closer to commercialization."

Ramius Value and Opportunity Advisors LLC, a subsidiary of Ramius LLC today announced that it delivered a letter to the Board of Directors of Cypress Bioscience, Inc. (Nasdaq:CYPB). In the letter, Ramius reiterated its offer to acquire the Company for $4.00 per share in cash plus a potential 50% interest in BL-1020 for total implied consideration of $4.39 per share. Ramius clarified the terms of its acquisition proposal and expressed a willingness to consider raising the value of its acquisition proposal in the event that Ramius is granted limited due diligence and the Company agrees to negotiate in good faith around consummating a transaction.

Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced today that its Chairman & CEO, Dr. Daniel Chain, was granted a patent by the European Patent and Trademark Office related to the use of insulin sensitizers for the prevention and treatment of memory loss and dementia. Insulin sensitizer drugs include Rosiglitazone and Pioglitazone, which have been approved for the treatment of type II diabetes mellitus. Dr. Chain is co-inventor of the patent with Professor Mike Cawthorne, Director of Metabolic Research, Clore Laboratory at The University of Buckingham and leader of the research team that originally discovered Rosiglitazone as a diabetes treatment. Dr. Chain applied for this patent prior to founding Intellect in 2005. Intellect Neurosciences holds an option to acquire the patent from its current owners.

calopre 12-08-10 13:35

Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company and Vibalogics GmbH, a German biologics manufacturing company, have agreed to co-develop a room temperature stable, processing technology for live vaccines originally engineered for Advaxis.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) announced executive management will participate in the Bank of AmericaMerrill Lynch Specialty Pharmaceuticals Conference to be held August 12-13, 2010 at The Southampton Inn, Southampton, NY.

BIOLASE Technology, Inc. (NASDAQ: BLT), the world's leading dental laser company, announced today that Chairman and Chief Executive Officer David M. Mulder is scheduled to make an investor presentation at the 2010 Southern California Investor Conference on Tuesday, August 17, at 8:00 am Pacific Time.

Bristol-Myers Squibb Company (NYSE: BMY) and the ADAP Crisis Task Force (ACTF) today announced an enhanced agreement to support the efforts of AIDS Drug Assistance Programs (ADAPs) to provide antiretroviral medicines to people living with HIV and AIDS.

Crucell N.V. (NYSE Euronext, NASDAQ: CRXL) today announced that it will release its financial results for the second quarter 2010 on Tuesday August 17, 2010 at 07:45 AM Central European Time (CET).

Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, announced today that it is participating in the International FIME 2010 Show for medical manufacturers.

Elan Corporation, plc ("Elan") (NYSE: ELN) today announced the pricing of the offering of US$200 million aggregate principal amount of 8.75% senior notes due 2016 ("Note") by its wholly-owned subsidiaries, Elan Finance public limited company and Elan Finance Corp.

Fibrocell Science, Inc. (OTC Bulletin Board:FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that David Pernock, Chairman and Chief Executive Officer, will present at the 2010 Global Hunter Securities Healthcare Conference at the Southern California Investor Conference on August 17, 2010 at 5:30 p.m. EDT (2:30 p.m. PDT).

Genoptix, Inc. (Nasdaq: GXDX), a specialized laboratory services provider, today announced the Company's participation at the Southern California Investor Conference to be held August 17, 2010 at The Island Hotel, Newport Beach, CA.

GeoVax Labs, Inc. (OTC Bulletin Board:GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announces that Chief Executive Officer Dr. Robert McNally and Chief Financial Officer Mark Reynolds will be presenting at the 2010 Southern California Investor Conference on Tuesday, August 17.

Gushan Environmental Energy Limited (NYSE:GU) announces that it will submit its unaudited second quarter 2010 financial results on Form 6-K to the U.S. Securities and Exchange Commission on Wednesday, August 18, 2010, to be followed by a conference call on the same day at 8:30 a.m. Eastern Daylight Time (or 8:30 p.m. Hong Kong Time) to discuss financial results for its second quarter ended June 30, 2010.

Imaging3, Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced today that on Thursday August 12, 2010 at 1:00pm PST, (4:00pm EST) the company's CEO, Mr. Dean Janes, will be hosting a conference call.

MannKind Corporation (Nasdaq: MNKD) today announced that it has entered into an agreement with Seaside 88, LP, a private investment limited partnership, for the sale of 700,000 shares of common stock to Seaside 88 every two weeks over the course of a year for a total of up to 18,200,000 shares of MannKind common stock.

NeoStem, Inc. (NYSE Amex:NBS) an international biopharmaceutical company with operations in the U.S. and China, announced today that it has entered into a sponsored research agreement (SRA) with the Schepens Eye Research Institute, a charitable corporation of Massachusetts and an affiliate of Harvard Medical School.

NexMed, Inc. (Nasdaq: NEXM), backed by a revenue generating CRO business and seeking to leverage its proprietary, multi-route NexACT® drug delivery technology and int rnal pipeline through out-licensing arrangements and partnerships, announced today that management will hold a conference call to discuss 2010 second quarter financial results and ongoing corporate activities, on Friday, August 13, 2010 at 12:00 p.m. ET.

PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) today announced its intention to issue up to 16,666,667 equity units, at a price per Unit of eighteen cents ($0.18) (the "Offering") for total proceeds of up to three million dollars ($3,000,000).

PetroAlgae Inc. (OTCBB: PALG) today announced that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission (SEC) relating to its proposed public offering of its common stock.

OXIS INTERNATIONAL, INC. (OTC Bulletin Board: OXIS, Paris: OXI) announced today the addition of Dr. Stephen Coles as the newest member to its Scientific Advisory Board.

RXi Pharmaceuticals Corporation (Nasdaq: RXII), a recognized leader in RNAi-based therapeutic discovery and development, today reported its financial results for the second quarter ended June 30, 2010.

SeraCare Life Sciences, Inc. (NASDAQ: SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today reported operational and financial results for its third quarter of fiscal year 2010, ended June 30, 2010.

Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in on cology, today reported that an overview of the Company's business strategy will be given at the 2010 Southern California Investor Conference, being held at the Island Hotel in Newport Beach, California.

Stellar Pharmaceuticals Inc. (OTCBB:SLXCF) ("Stellar" or "the Company"), a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, today announced that its President and Chief Executive Officer, Peter Riehl, is scheduled to present an update of the Company's business at the upcoming 2010 Southern California Investor Conference sponsored by Global Hunter Securities.

Temasek Life Science Ventures Pte Ltd (TLV) and Emergent BioSolutions Inc. (NYSE:EBS) today announced their agreement to form EPIC BIO Pte Ltd, a join venture to develop, manufacture, and commercialize a multivalent, cross-protective human vaccine to protect against influenza caused by a broad range of circulating H5 influenza strains.

Tengion Inc. (Nasdaq:TNGN) today provided a corporate and product development update and reported its financial results for the quarter ended June 30, 2010.

Tongjitang Chinese Medicines Company (NYSE:TCM), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced that it plans to release its second quarter 2010 financial results after market close on Wednesday, August 18, 2010.

Transdel Pharmaceuticals, Inc. (OTC Bulletin Board:TDLP) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel™ cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier.

Urigen Pharmaceuticals, Inc. (OTCQB: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced it has formally requested a Phase II Type C discussion with the FDA for its URG101 program for Painful Bladder Syndrome/Interstitial Cystitis.

Valeant Pharmaceuticals International (NYSE: VRX) and Biovail Corporation (NYSE/TSX: BVF) today announced that both companies will hold th ir respective special meetings of shareholders on September 27, 2010 for the purpose of considering and voting upon proposals relating to the companies' previously announced merger.

Wound Management Technologies, Inc. (OTC Bulletin Board:WNDM) is pleased to announce the sales expansion of its advanced wound care collagen product, CellerateRX, into South Africa.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

calopre 12-08-10 18:09

ddss a 1 dollaro
NASDAQ PONIARD PHARM
AMEX ULURU
entra ALXA
XOMA
tutto a piccole dosi
ULURU una scommessa

calopre 13-08-10 17:04

FDA Calendar


Date Company Name Ticker Drug Event Outcome Details
10/12/2010 Alkermes, Inc. ALKS Vivitrol (sNDA) FDA decision on Vivitrol for additional indication as a treatment of opioid dependence


-Approved in Other Countries




10/11/2010 Alexza Pharmaceuticals Inc. ALXA AZ-004 (NDA ) FDA decision on AZ-004 for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

SE andrà bene saranno fuochi artificiali



10/03/2010 JAVELIN PHARMACEUTICALS JAV Dyloject (NDA) FDA decision on Dyloject for the management of acute moderate-to-severe postoperative pain in adults
-Rival Drugs



-Approved in Other Countries




09/17/2010 Roche Group RO.SW, ROG.SW Avastin (sBLAs) FDA to make a decision on first-line use of Avastin in combination with certain types of chemotherapy for advanced breast cancer


-Approved in Other Countries




09/16/2010 Arena Pharmaceutical Inc ARNA Lorcaserin (NDA) FDA panel to review Lorcaserin for weight management



-News

09/16/2010 Alkermes, Inc. ALKS Vivitrol (sNDA) FDA panel to review Vivitrol for additional indication of opioid dependence treatment


-Approved in Other Countries


-News

09/14/2010 Savient Pharmaceuticals Inc SVNT Krystexxa (Amended BLA) FDA decision on Krystexxa for chronic gout in patients refractory to conventional therapy. -Drug Status



-Market Potential



-News

09/11/2010 QUESTCOR PHARMACEUTICALS INC QCOR H.P. Acthar Gel (sNDA) FDA decision on H.P. Acthar Gel for additional indication as treatment for infantile spasms -Drug Status


-Rival Drugs




-News

09/10/2010 Cumberland Pharmaceuticals Inc CPIX Acetadote (sNDA) FDA decision on Acetadote for additional indication as treatment of patients with non-acetaminophen acute liver failure


-Approved in Other Countries


-News

09/07/2010 Forest Laboratories Inc FRX Ceftaroline fosamil injection (NDA) FDA panel to review Ceftaroline for treatment of adults with community acquired bacterial pneumonia and complicated skin and skin structure infections
-Rival Drugs


-Market Potential





08/26/2010 Electro-Optical Sciences Inc MELA MelaFind (device) pre-market approval application FDA panel to review cancer screener MelaFind FDA panel meeting postponed to November



-News

08/20/2010 JAZZ PHARMA INC JAZZ JZP-6 (NDA) FDA panel to review JZP-6 for treatment of fibromyalgia -Drug Status


-Rival Drugs




-News

08/19/2010 Eli Lilly And Co. LLY Cymbalta (sNDA) FDA panel to review Cymbalta for proposed indication of treatment of chronic pain


-Approved in Other Countries




07/28/2010 AstraZeneca PLC AZN, AZN.L Brilinta, known chemically as Ticagrelor (NDA) FDA panel to review Brilinta in the treatment of acute coronary syndrome FDA Advisory Committee recommended approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes

-Rival Drugs


-Market Potential



-News

07/27/2010 Theratechnologies TH.TO Tesamorelin (NDA) FDA decision on Tesamorelin for the treatment of excess abdominal fat in HIV patients with lipodystrophy FDA decision date extended to fourth quarter of 2010



-News


Previous 15 Records

calopre 14-08-10 17:15

PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) announced today it has received a letter from Genentech claiming that Avastin, Herceptin, Lucentis and Xolair do not infringe supplementary protection certificates granted by various countries in Europe to PDL, greatly putting into risk royalty payments that PDL counts on for about 30% of its revenue.

PDL asserted that its European patents on the technology run through 2014 and it plans to vigorously enforce those rights.

Shares of PDL BioPharma fell 16.45% or $1.02 to close Friday's trading at $5.18.

Watson Pharmaceuticals, Inc. (NYSE:WPI), today after the bell announced that it intends to launch ella® (ulipristal acetate), a novel oral emergency contraceptive, in the fourth quarter of 2010. Watson's announcement follows the approval of ella® by the FDA as safe and effective in preventing unintended pregnancy for up to 120 hours – or five days – post-unprotected intercourse (UPI) or contraceptive failure. ella® was developed by HRA Pharma specifically for emergency contraception and is not intended for routine contraceptive use. ella® will be marketed by Watson in the United States under terms of an exclusive distribution agreement announced earlier this year.

"ella® is an important new contraceptive option for U.S. women, and its unique efficacy profile will give women an additional therapeutic alternative for preventing unintended pregnancy," said Fred Wilkinson, Executive Vice President, Global Brands at Watson. "Beginning later this year, Watson will be offering women a novel emergency contraceptive that represents a logical, therapeutic complement to NextChoice®, our generic levonorgestrel-based emergency contraceptive."

Also Friday:

Adherex Technologies Inc. (TSX:AHX)(PINK SHEETS:ADHXF), a biopharmaceutical company dedicated to providing innovative therapies that improve the life of cancer patients, today reported its financial results for the second quarter ended June 30, 2010.All amounts are in U.S. dollars.
Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) announced today financial results for the three months ended June 30, 2010.
Biovest International, Inc. (OTCQB:BVTI) today announced that the U.S. Department of Defense (DoD), Naval Health Research Center (NHRC), presented encouraging preliminary results demonstrating that Biovest's hollow fiber bio-manufacturing system is capable of efficiently producing a strain of pandemic A/H1N1 influenza virus.
Chemspec International Limited (NYSE:CPC) a leading China-based contract manufacturer of highly-engineered specialty chemicals, today announced its unaudited financial results(1) for the second quarter ended June 30, 2010.
Daxor Corporation, (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced second quarter earnings for 2010
Dyadic International, Inc. ("Dyadic") (Pink Sheets:DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of specialty enzyme products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, today announced financial results for the second quarter ended June 30, 2010.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today it has entered into an Executive Employment Agreement with Charles A. Johnson, M.D., who will become Executive Vice President of Research and Development and Chief Medical Officer, effective September 15, 2010.
Leatt Corporation, (PINKSHEETS: LEAT) and the developer of the Leatt-Brace®, a Neck Brace System designed to help prevent potentially devastating motor sport injuries to the cervical spine (neck), today announced unaudited financial results for its fiscal 2010 second quarter ended June 30, 2010.
Medtronic, Inc. (NYSE: MDT) announced today it will report financial results for the first quarter of its fiscal year 2011 on Tuesday, August 24, 2010.
Mylan Inc. (Nasdaq:MYL) today announced that it has completed a private placement of $300 million aggregate principal amount of Senior Notes due 2020.
Pro-Pharmaceuticals, Inc. (OTC: PRWP), a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today reported its financial results for the second quarter and the first six months ended June 30, 2010.
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that Nasdaq has granted the Company until October 31, 2010 to meet the minimum bid price requirement of the Nasdaq Capital Market. Listing Rule 5550(a)(2) requires the Company to maintain a minimum bid price of $1.00 for a minimum of ten consecutive trading days.
SANUWAVE Health, Inc. (OTCBB:SNWV), an emerging medical technology company focused on regenerative medicine, today reported financial results for the three and six months ended June 30, 2010 and provided a business update.
Skystar Bio-Pharmaceutical Company (NASDAQ: SKBI) a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, will report its unaudited financial results for the second quarter of 2010 on Monday, August 16, 2010 after the close of the market.
Trubion Pharmaceuticals, Inc. (Nasdaq:TRBN) today announced that it plans to issue earnings results for the second quarter and first six months ended June 30, 2010, after the close of market on Aug. 16, 2010.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

alex1664 15-08-10 12:39

Citazione:

Originalmente inviato da calopre (Messaggio 26229798)
PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) announced today it has received a letter from Genentech claiming that Avastin, Herceptin, Lucentis and Xolair do not infringe supplementary protection certificates granted by various countries in Europe to PDL, greatly putting into risk royalty payments that PDL counts on for about 30% of its revenue.

PDL asserted that its European patents on the technology run through 2014 and it plans to vigorously enforce those rights.

Shares of PDL BioPharma fell 16.45% or $1.02 to close Friday's trading at $5.18.

Watson Pharmaceuticals, Inc. (NYSE:WPI), today after the bell announced that it intends to launch ella® (ulipristal acetate), a novel oral emergency contraceptive, in the fourth quarter of 2010. Watson's announcement follows the approval of ella® by the FDA as safe and effective in preventing unintended pregnancy for up to 120 hours – or five days – post-unprotected intercourse (UPI) or contraceptive failure. ella® was developed by HRA Pharma specifically for emergency contraception and is not intended for routine contraceptive use. ella® will be marketed by Watson in the United States under terms of an exclusive distribution agreement announced earlier this year.

"ella® is an important new contraceptive option for U.S. women, and its unique efficacy profile will give women an additional therapeutic alternative for preventing unintended pregnancy," said Fred Wilkinson, Executive Vice President, Global Brands at Watson. "Beginning later this year, Watson will be offering women a novel emergency contraceptive that represents a logical, therapeutic complement to NextChoice®, our generic levonorgestrel-based emergency contraceptive."

Also Friday:

Adherex Technologies Inc. (TSX:AHX)(PINK SHEETS:ADHXF), a biopharmaceutical company dedicated to providing innovative therapies that improve the life of cancer patients, today reported its financial results for the second quarter ended June 30, 2010.All amounts are in U.S. dollars.
Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) announced today financial results for the three months ended June 30, 2010.
Biovest International, Inc. (OTCQB:BVTI) today announced that the U.S. Department of Defense (DoD), Naval Health Research Center (NHRC), presented encouraging preliminary results demonstrating that Biovest's hollow fiber bio-manufacturing system is capable of efficiently producing a strain of pandemic A/H1N1 influenza virus.
Chemspec International Limited (NYSE:CPC) a leading China-based contract manufacturer of highly-engineered specialty chemicals, today announced its unaudited financial results(1) for the second quarter ended June 30, 2010.
Daxor Corporation, (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced second quarter earnings for 2010
Dyadic International, Inc. ("Dyadic") (Pink Sheets:DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of specialty enzyme products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, today announced financial results for the second quarter ended June 30, 2010.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today it has entered into an Executive Employment Agreement with Charles A. Johnson, M.D., who will become Executive Vice President of Research and Development and Chief Medical Officer, effective September 15, 2010.
Leatt Corporation, (PINKSHEETS: LEAT) and the developer of the Leatt-Brace®, a Neck Brace System designed to help prevent potentially devastating motor sport injuries to the cervical spine (neck), today announced unaudited financial results for its fiscal 2010 second quarter ended June 30, 2010.
Medtronic, Inc. (NYSE: MDT) announced today it will report financial results for the first quarter of its fiscal year 2011 on Tuesday, August 24, 2010.
Mylan Inc. (Nasdaq:MYL) today announced that it has completed a private placement of $300 million aggregate principal amount of Senior Notes due 2020.
Pro-Pharmaceuticals, Inc. (OTC: PRWP), a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today reported its financial results for the second quarter and the first six months ended June 30, 2010.
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that Nasdaq has granted the Company until October 31, 2010 to meet the minimum bid price requirement of the Nasdaq Capital Market. Listing Rule 5550(a)(2) requires the Company to maintain a minimum bid price of $1.00 for a minimum of ten consecutive trading days.
SANUWAVE Health, Inc. (OTCBB:SNWV), an emerging medical technology company focused on regenerative medicine, today reported financial results for the three and six months ended June 30, 2010 and provided a business update.
Skystar Bio-Pharmaceutical Company (NASDAQ: SKBI) a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, will report its unaudited financial results for the second quarter of 2010 on Monday, August 16, 2010 after the close of the market.
Trubion Pharmaceuticals, Inc. (Nasdaq:TRBN) today announced that it plans to issue earnings results for the second quarter and first six months ended June 30, 2010, after the close of market on Aug. 16, 2010.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

ciao calo, di telk che mi dici?? 65% tra insider e istitutional aumentati di recente, e graficamente potrebbe esplodere...

calopre 15-08-10 23:38

nel 2006 risultati negativi di una molecola,che adesso vorrebbero sviluppare con un partner per riproporla.generalmente sono operazioni per mantenere i propri stipendi più a lungo possibile. resto pipeline ancora in alto mare e comunque marchiato negativamente dai risultati raggiunti. ha fatto 0,20 /20 dollari ha ancora capitale per la sopravvivenza e dal punto di vista speculativo all'arrivo di una notizia che indica un progresso delle molecole o una partnership potrebbe fare 1,4 1,8. da osservare anche perchè non ha problemi con il mercato in cui è quotata.

alex1664 16-08-10 00:24

Citazione:

Originalmente inviato da calopre (Messaggio 26233761)
nel 2006 risultati negativi di una molecola,che adesso vorrebbero sviluppare con un partner per riproporla.generalmente sono operazioni per mantenere i propri stipendi più a lungo possibile. resto pipeline ancora in alto mare e comunque marchiato negativamente dai risultati raggiunti. ha fatto 0,20 /20 dollari ha ancora capitale per la sopravvivenza e dal punto di vista speculativo all'arrivo di una notizia che indica un progresso delle molecole o una partnership potrebbe fare 1,4 1,8. da osservare anche perchè non ha problemi con il mercato in cui è quotata.

beh se gli insider hanno aumentato la partecipazione del 30% nell'ultimo mese, la "new" dovrebbe arrivare a breve....;)

visal 16-08-10 15:13

SAlute CALOPRE
io sono dentro da tempo su queste due mega ciofecona
ARYX e ULU
Aspetto fducioso in quando ARYX ha diversi farmaci in dase di approvazione solo a fine mese penso non abbia + 1$ in prt quindi o si sbrica a fare uscire il coniglio bianco dal cilindro oppure sono dolori ( emmorroidari)
Ulu invece la vedo piu' brillante anche se li e' una scommessa a lungo termine + o - x fine anno
Vediamo che fanno oggi dopo il ferragosto

calopre 16-08-10 19:09

ARYx secures important bridge financing PDF | Print | E-mail
Written by Staff and Wire Reports
Monday, 16 August 2010 09:22
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We have an update to our profile for the small-cap biotech with 3 mid-stage drugs that will be ready for Phase 3 trials in the coming months. As we told you, ARYx had explored the possibility of capturing full near-term value for its three lead programs rather than pursuing licensing deals, but things may be changing and this news could be good for investors.

ARYx Therapeutics, Inc. (NASDAQ:ARYX) today announced that it has secured bridge financing to allow ARYx time and resources to potentially complete a transaction that could create significant value for stockholders. ARYx also released its financial results for the second quarter of 2010.

ARYX THERAPEUTICS
0.43 -0.03 (-6.52%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.The bridge financing comes from two related loan transactions. The first is a bridge loan financing of up to $4 million from two existing investors, including entities affiliated with MPM Capital (the “Bridge Loan”). The closing of the initial tranche of $2.0 million of the Bridge Loan closed on August 13, 2010. Concurrent with the initial tranche closing of the Bridge Loan, ARYx also amended its existing loan agreement with Lighthouse Capital Partners V, L.P. (“Lighthouse”). The amendment of the Lighthouse loan allows approximately $2.3 million of required payments to Lighthouse to be deferred and extended as a new loan commitment to ARYx. Based on previously disclosed projections and supported by the financial results released today, ARYx believes the proceeds and anticipated proceeds from these financings, totaling up to $6.3 million, should allow ARYx to operate through the end of 2010.

“The securing of this bridge financing is significant to ARYx since it now gives us the time to complete a strategic transaction that, if finalized, could realize real value from our product portfolio. The participation of our existing investors in the bridge loan financing follows their conducting significant due diligence on the company and our progress to date towards a potential transaction. Therefore, we believe this financing is a vote of confidence by important current investors,” said Dr. Paul Goddard, ARYx chairman and chief executive officer. “We also believe that the additional participation by Lighthouse further strengthens our ability to complete the on-going strategic process,” concluded Dr. Goddard.


allungata la vita è diventata una scommessa

visal 16-08-10 19:41

Notizia buona ma continua a scendere

alex1664 16-08-10 20:53

Citazione:

Originalmente inviato da visal (Messaggio 26240163)
Notizia buona ma continua a scendere

tra poco hanno un prodotto che dovrebbe passare in fase 3, sulla notizia potrebbe esplodere...che ne dite?
Tecarfarin (ATI-5923)
Anticoagulation

alex1664 16-08-10 20:55

la domanda è: con quali soldi la portano avanti?

calopre 17-08-10 09:52

Prospect Medical acquired, shares soar PDF | Print | E-mail
Written by BioMedReports.com Staff
Monday, 16 August 2010 18:17
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Below is a list of the companies that made news in the healthcare sector on Monday, August 16, 2010.
Prospect Medical Holdings, Inc. (Nasdaq: PZZ) announced today that it has entered into a definitive merger agreement to be acquired for $8.50 per share in cash by an entity sponsored by Leonard Green & Partners, L.P. in which certain stockholders of Prospect will also participate. The total transaction value is approximately $363 million, including the assumption of approximately $158 million in Prospect’s net debt.
The merger price represents a 38.9% premium over the closing sale price of Prospect shares on August 13, 2010, and a 29.4% premium to the volume weighted-average closing sale price of approximately $6.57 during the 30 trading days prior to that date.

Prospect Medical Holdings owns and operates five community-based hospitals in the greater Los Angeles area, and manages the provision of healthcare services of HMO enrollees in southern California, through its network of specialist and primary care physicians.

Shares rose $2.42 or 39.54% to $8.54.

USANA Health Sciences, Inc. (NASDAQ:USNA) today after the bell announced that it has acquired BabyCare Ltd, a China-based direct selling company that develops, manufactures and sells nutritional products for the entire family, with an emphasis on infant nutrition. Founded in 1999, privately held BabyCare Ltd is headquartered in Beijing, China, with operations in 21 cities and 16 provinces. BabyCare’s products are sold through a growing distributor sales force, utilizing a commission-based compensation plan under a license to engage in direct selling activities in the Municipality of Beijing. BabyCare is working to obtain similar licenses in the other provinces in which it operates. This direct selling license allows BabyCare to engage non-employee distributors to sell BabyCare’s products, apart from the company’s traditional service centers. The purchase price for the shares consisted of $45 million in cash and 400,000 shares of USANA stock.

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced that its partner, Green Cross Corporation has received marketing and manufacturing approval from KFDA (Korean Food & Drug Administration) for intravenous (i.v.) peramivir to treat patients with influenza A & B viruses, including pandemic H1N1 and avian influenza. Green Cross Corp. intends to launch peramivir under the commercial name PeramiFlu in South Korea.

Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that it has received notice that the European Medicines Agency ("EMEA") has validated the expanded Pediatric Investigation Plan ("PIP") that CTI filed in July for pixantrone for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Following the validation, the EMEA Pediatric Committee (the "PDCO") will review and comment or approve the content of pediatric plan. Once the PIP is approved, CTI will submit the Marketing Authorization Application ("MAA") for pixantrone in the E.U. later this year. The pediatric program will study pixantrone in pediatric patients aged 6 months to 18 years with the goal of determining the comparative safety and effectiveness of pixantrone compared to doxorubicin in pediatric lymphoid cancers.

Cryo-Cell International, Inc. (OTCBB:CCEL) one of the world's largest and most established family cord blood banks today announced that it has engaged Morgan Joseph LLC, a full service investment bank, to evaluate strategic acquisition opportunities available to enhance value for Cryo-Cell's shareholders. Morgan Joseph's Healthcare Investment Banking Group will serve as the Company's exclusive financial advisor and investment banker to evaluate a broad range of strategic growth acquisitions for Cryo-Cell's global cord blood banking business and the Company's proprietary Celle menstrual stem cell technology portfolio and to manage any prospective transaction process that may evolve from such evaluation.

Also Monday:

A5 Laboratories Inc. (A5 Labs (OTCBB:AFLB) today announced the appointment of Ms. Valentyna Navala to the position of Director of Microbiology and Interferon Clinical Programs and Mr. Chakib Rhofir to the position of Director of CRO Scientific Affairs.

Adeona Pharmaceuticals, Inc. (AMEX:AEN) announced today its second quarter 2010 financial results and recent achievements.
AMRI (NASDAQ: AMRI) announced today that it has been selected as the inaugural winner of the Pfizer Route Design Innovation Award, beating out 40 companies who were invited to share innovative ideas for process chemistry and large scale Active Pharmaceutical Ingredient (API) production. Pfizer will present the company with the award at the AMRI 2010 Integrated Drug Discovery Symposium to be held in Albany NY, October 13-14. AMRI will also receive an honorarium for its win.
A.P. Pharma, Inc. (NASDAQ: APPA), a specialty pharmaceutical company, today reported financial results for its second quarter ended June 30, 2010.
ARYx Therapeutics, Inc. (NASDAQ:ARYX) today announced that it has secured bridge financing to allow ARYx time and resources to potentially complete a transaction that could create significant value for stockholders. ARYx also released its financial results for the second quarter of 2010.
Axxess Pharma, Inc. (PINKSHEETS: AXXE), a pharmaceutical company specializing in the marketing and distribution of both prescription and non-prescription medical products, is pleased to report they have generated $1.3 million in annual sales from their non-constipating multi-vitamin Triferrex 150.
BioPharm Asia, Inc.(OTCBB: BFAR) announced today that its newly-acquired subsidiary, Beijing Zhihe Ruikang Hospital Management Ltd., is negotiating to acquire a controlling interest in Shandong Weifang Municipal Hospital.
BioTime, Inc. (NYSE Amex:BTIM) today reported financial results for the quarter ended June 30, 2010 and provided an update on recent corporate developments.
Bristol-Myers Squibb Company (NYSE:BMY) announced today that belatacept, an investigational selective T cell co-stimulation blocker being studied for use in solid organ transplantation, will be the subject of seven oral clinical presentations related to kidney transplantation at the 23rd International Congress of The Transplantation Society, being held August 15–19, 2010, in Vancouver, British Columbia, Canada.
Bruker Corporation (NASDAQ: BRKR) today announces the signing of an agreement to acquire the Scanning Probe Microscopy (SPM) and Optical Industrial Metrology (OIM) instruments business from Veeco Instruments, Inc. (NASDAQ: VECO) for $229 million in cash.
CEL-SCI Corporation (NYSE AMEX: CVM) reported today financial results for its third fiscal quarter for the period ended June 30, 2010.
China Biologic Products, Inc. (Nasdaq:CBPO) one of the leading plasma-based biopharmaceutical companies in the People's Republic of China ("PRC"), operating through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co. Ltd. ("Taibang") and Guiyang Dalin Biologic Technologies Co., Ltd. ("Dalin") and its equity investment in Xi'an Huitian Blood Products Co., Ltd. ("Huitian"), today reported financial results for its second quarter ended June 30, 2010.
China Jo-Jo Drugstores, Inc. (NASDAQ:CJJD) which operates a retail pharmacy chain in the People's Republic of China (the "PRC"), today reported its financial results for the fiscal quarter ended June 30, 2010.
EntreMed, Inc. (Nasdaq:ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, today reported financial results for the three and six-month periods ending June 30, 2010.
Gamma Pharmaceuticals Inc. (PINKSHEETS: GMPM): announced that manufacturing is under way for several of its product lines pursuant to customer purchase orders, including Gamma's $48.0 million annualized guaranteed sales contract announced March 3rd 2010, and that shipping to retailers is expected to begin soon.
HemaCare Corporation (OTCBB:HEMA) today announced that it has named Anna Stock as Chief Operating Officer and Lisa Bacerra as Chief Financial Officer effective immediately.
Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) today reported financial results for the quarter ended June 30, 2010.
Interleukin Genetics, Inc. (OTCQB: ILIU) today announced that trading of shares of the Company's common stock will be transferred from the NYSE Amex to the OTCQB™ Marketplace effective today, August 16, 2010.
Jiangbo Pharmaceuticals, Inc. (Nasdaq:JGBO) today announced that the Company received approval from the Shandong Food and Drug Administration ("Shandong FDA") to start the sales of Felodipine sustained release ("SR") tablets.
LecTec Corporation (OTCBB: LECT) announced today that it has released its 2010 second quarter financial information. LecTec's cash and cash equivalents decreased $6,132,024 for the six month period ended June 30, 2010, to $9,634,083 from cash and cash equivalents of $15,766,107 at December 31, 2009.
Lotus Pharmaceuticals, Inc. (OTC Bulletin Board:LTUS) a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China (the "PRC"), reported today its financial results for the quarter and six months ended June 30, 2010.
Medco Health Solutions, Inc. (NYSE:MHS) and United BioSource Corporation (UBC) today announced a definitive agreement under which Medco will acquire closely held UBC in an all-cash transaction valued at approximately $730 million.
MMRGlobal, Inc. (OTCBB: MMRF) today filed its quarterly statement for the six months ended June 30, 2010.
NanoViricides, Inc. (OTC BB: NNVC.OB) reports that its anti-Herpes drug candidates demonstrated significant efficacy in the recently completed cell culture studies.
NeoStem, Inc. (NYSE Amex:NBS) an international biopharmaceutical company with product and service revenues, global research and development capabilities and operations in three distinct business units, U.S. adult stem cells, China adult stem cells, and China pharmaceuticals is today providing results of its second quarter 2010.
Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced its second quarter financial results for 2010.
Nutrastar International Inc. (OTC Bulletin Board:NUIN), a leading nutraceutical company which produces and distributes Chinese Golden Grass ("Cordyceps Militaris") and other specialty food products, today announced financial results for their three and six months ended June 30, 2010.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company primarily focused on the pediatric market, today announced results for the quarter and six months ended June 30, 2010.
Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today Mr. Mathi Senapathi has joined the Company's executive management team as Director of Manufacturing, responsible for the manufacturing of RPC's Onko-Sure® in vitro diagnostic (IVD) cancer test kits.
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that Nasdaq has granted the Company until October 31, 2010 to meet the minimum bid price requirement of the Nasdaq Capital Market. Listing Rule 5550(a)(2) requires the Company to maintain a minimum bid price of $1.00 for a minimum of ten consecutive trading days.
SANUWAVE Health, Inc. (OTCBB: SNWV) an emerging medical technology company focused on the development and commercialization of non-invasive, iological response activating devices in regenerative medicine, today announced that the Company will showcase their newest device, Profile, which incorporates innovative Diffused Acoustic Pressure (DAP) technology, at the 20TH Biennial Congress of the International Society of Aesthetic Plastic Surgery (ISAPS) beginning during exhibition yesterday, August 15th, and running through August 18th, 2010 in San Francisco, CA.
Titan Pharmaceuticals, Inc. (OTC Bulletin Board:TTNP) today reported financial results for the second quarter ended June 30, 2010.
Vitacost.com, Inc. (NASDAQ: VITC), a leading online retailer and direct marketer of health and wellness products, today reported financial results for the second quarter ended June 30, 2010.
Weikang Bio-Technology Group Co., Inc. (OTC Bulletin Board:WKBT) a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced its fiscal 2010 second quarter results for period ended June 30, 2010.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.



BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section

visal 17-08-10 15:36

POtenzialmente con basso flottante questa potrebbe esplodere ma solo se il farmaco in fase 3 fosse approvato
E' un farmaco innovativo che sostituirebbe il vecchio anticoagulante xche' sembrerebbe + stabile
A quando il verdetto FDA questo nessuno lo sa??

calopre 17-08-10 17:23

Medtronic set to acquire Osteotech PDF | Print | E-mail
Written by Staff and Wire Reports
Tuesday, 17 August 2010 08:04
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Medtronic Inc., (NYSE:MDT) and Osteotech, Inc., (Nasdaq:OSTE) today announced that the companies have signed a definitive agreement under which Medtronic will acquire Osteotech for $6.50 per share in cash for each share of Osteotech common stock. The total value of the transaction is expected to be approximately $123 million. Osteotech is a leader in the growing field of biologic products for regenerative healing, and has pioneered several innovative technology platforms including Grafton® demineralized bone matrix, a family of products which has a large and growing body of evidence supporting its best-in-class bone generating capabilities. Osteotech's differentiated portfolio of biologics also includes MagniFuse™ Bone Grafts and Plexur® Biocomposites, which are utilized in a broad range of musculoskeletal surgical procedures. In addition, Osteotech is in the midst of seeking U.S. Food & Drug Administration clearance for the first product based upon its first-in-class HCT™ (Human Collagen Technology) platform, an engineered human collagen biomaterial.

OSTEOTECH
6.45 +2.51 (+63.71%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.The acquisition of Osteotech will complement the Medtronic Biologics business' bone healing portfolio and expand its current presence in spine, orthopedic trauma, and dental into several additional new treatment areas including joint reconstruction, foot and ankle, and sports medicine. In addition, the combined technical and product capabilities will create opportunities to develop breakthrough next-generation products.

"This acquisition represents a key step in Medtronic's strategy to build a broader business in regenerative biologics," said Chris O'Connell, Medtronic executive vice president and Restorative Therapies Group president. "Osteotech's products and capabilities will better position Medtronic in today's competitive musculoskeletal biologics market, and also position the company more broadly for the opportunity we see in the future."

calopre 17-08-10 19:37

potete dirmi quacosa dal punto di vista grafico di poniard
ringrazio

credo sia sui supporti, da quì dovrebbe rimbalzare
PONIARD PHARMACEUTICALS INC Analyst Recommendations Analyst Consensus: PARD
First Call Consensus RecommendationStrong Buy
1
Buy
2
Hold
3
Sell
4
Strong Sell
5
Mean Analyst Consensus Recommendation Analysts Reporting
Current Recommendation 3.500 Underperform 4
30 Days Ago 3.800 Underperform 5
60 Days Ago 4.000 Underperform 6
90 Days Ago 3.444 Hold 9
120 Days Ago 3.400 Hold 10
Analyst Ratings: PARD
Brokerage Firm Previous Rating Current Rating Change Date Price Target
Rodman & Renshaw Mkt Perform Mkt Outperform 06/08/2010 2.00
Brean Murray Buy — 04/27/2010 4.00
Canaccord Adams Hold Sell 01/25/2010 1.00
Canaccord Adams Buy Hold 11/18/2009 —
Wedbush Morgan Outperform Underperform 11/17/2009 —
Rodman & Renshaw Mkt Outperform Mkt Perform 11/16/2009 —
Needham Buy Hold 11/16/2009 —
Merriman Buy Neutral 11/16/2009 —
BMO Capital Markets — Outperform 10/06/2009 —
Brean Murray — Buy 07/02/2009 11.00
Wedbush Morgan — Buy 03/20/2009 6.00
Needham — Buy 03/18/2009 6.00
Lazard Capital — Buy 02/09/2009 6.00
Oppenheimer — Outperform 12/01/2008 8.00
Credit Suisse — Outperform 10/03/2007 10.00
Oppenheimer — Buy 06/21/2007 13.00
Rodman & Renshaw — Mkt Outperform 06/04/2007 10.00
Lazard Capital — Buy 05/07/2007 11.00
CIBC Wrld Mkts — Sector Outperform 05/07/2007 13.00
Cantor Fitzgerald — Buy 03/16/2007 12.00
Fortis Bank — Buy 03/08/2007 8.00
Rodman & Renshaw — Mkt Outperform 01/29/2007 7.00
Cantor Fitzgerald — Buy 11/29/2006 9.00

calopre 18-08-10 08:59

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced that its board of directors has approved a 1-for-15 share consolidation, or reverse stock split, that will become effective with the opening of trading on August 18, 2010. The primary objective in effecting a reverse stock split at this time is to better enable the company to maintain the listing of its common shares on The NASDAQ Global Market. The company's common shares will continue trading on The NASDAQ Global Market and will begin trading on a split-adjusted basis at the opening of trading on Wednesday, August 18, 2010.

In news from earlier in the day:

Osteotech's (Nasdaq:OSTE) soared more than 63% today after agreeing to be acquired by Medtronics for $6.50 cash per share. The full story was reported here on BioMedReports earlier today. The stock closed the day at $6.44, up $2.50 from yesterdays close.

Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC) announced today that it is positioned to obtain significant patents relating to cellular reprogramming and the generation of induced pluripotent stem (iPS) cells. iPS cells are similar to embryonic stem (ES) cells, except they are generated from adult cells − such as skin − using certain reprogramming factors, without the controversial use of embryos. Although human iPS cells were first produced in 2007, ACT has been working on inducing pluripotency, with positive results, for more than a decade. The Company’s efforts go back to the 1990s, providing (through existing patent filings and continuations) some of the earliest priority dates in the field.

"ACT is pursuing claims (published and unpublished) that, if granted, would dominate the use of what the rest of the research community is now coming to understand are the key regulators of induced pluripotency," said William M. Caldwell IV, the Company’s Chairman and CEO.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the first subject has initiated treatment in a Phase 3b study (PKU-016) to evaluate the effects of Kuvan (sapropterin dihydrochloride) on neuropsychiatric symptoms in subjects with phenylketonuria (PKU). BioMarin expects to report results in the first half of 2012.

Eli Lilly and Company (NYSE:LLY) will halt development of semagacestat, a gamma secretase inhibitor being studied as a potential treatment for Alzheimer's disease, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.

The company's decision does not affect the ongoing clinical trials of solanezumab, Lilly's other compound in Phase III trials as a potential Alzheimer's treatment. While both drugs focus on amyloid-beta proteins, which are believed to play a critical role in Alzheimer's disease, they have different mechanisms of action. Lilly also has two other compounds in earlier stages of clinical development; those studies are not affected by today's announcement.

Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI), a biopharmaceutical company discovering and developing targeted therapeutic and imaging radiopharmaceuticals for use in oncology, today announced that the Company has received a seventh extension of its waiver agreement with its Bond holders, allowing debt restructuring discussions to progress.

Palatin Technologies, Inc. (NYSE Amex: PTN) today announced positive results of a Phase 1 clinical trial of subcutaneously administered bremelanotide, its melanocortin agonist drug candidate for treatment of male erectile dysfunction (ED) and female ***ual dysfunction (FSD). The results demonstrate that with subcutaneous administration consistent therapeutic blood plasma levels can be obtained without sustained clinically significant blood pressure effects and support the continued development of bremelanotide.

Skystar Bio-Pharmaceutical Company (NASDAQ:SKBI) a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, today reported unaudited second quarter fiscal year 2010 earnings, for the period ended June 30, 2010. Second Quarter 2010 revenue increased 33% YoY to $8.3 million.

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calopre 18-08-10 18:05

BOSTON, Mass. (TheStreet) --The dog days of August are here. Nothing of much importance is going on. It's hot and humid in Boston, and I'm getting ready for a much-needed vacation. The rest will come in handy because the biotech sector gets back to business in September.
More from Adam Feuerstein Jazz Pharma: FDA Speaks Before Friday's Panel10 Alzheimer's Disease Treatment StocksBiotech Stock Mailbag Readers' Portfolio: UpdateEli Lilly Halts Alzheimer's Drug TrialBiotech Stock Mailbag - Second Quarter UpdatesGlaxo Slaps Former Sirtris ExecsVertex Halves Hep C Treatment TimeArena Pharma: Deja Vu DangerBiotech Stock Mailbag: AlkermesSafety of Isis, Genzyme Drug Still a Worry Market Activity Endo Pharmaceutical Holdings Inc.| ENDP UPSpectrum Pharaceuticals Inc.| SPPI DOWNGenzyme Corporation| GENZ DOWNTo get you ready, I've put together a calendar of September biotech events. Enjoy. Aug. 24

U.S. Food and Drug Administration's responds to Cell Therapeutics'(CTIC) priority review request for pixantrone as a treatment for non-Hodgkin's lymphoma.

Sept. 1

The Oncologic Drug Advisory Committee of the Food and Drug Administration meets to review Genzyme's(GENZ) Clolar and Vion Pharmaceuticals'(VION.OB) Onrigin, both as a treatment for acute myeloid leukemia.
Sept. 2

The same FDA advisory committee meets to review Allos Therapeutics'(ALTH) pralatrexate for peripheral T-cell lymphoma.

FDA approval decision date for Endo Pharmaceuticals'(ENDP) Nebido, a long-acting testosterone replacement therapy.
Sept. 7

FDA approval decision date for Spectrum Pharmaceuticals'(SPPI) Zevalin, a drug for non-Hodgkin's lymphoma.
Sept. 9-10

Robert W. Baird Small Cap Health Care Conference
Sept. 9-11

Thomas Weisel Partners Healthcare Conference (Boston) and the Rodman & Renshaw 11th Annual Healthcare Conference (New York City)
Sept. 11-15

American Society for Bone and Mineral Research (ASBMR)
Sept. 12-15

Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
Sept. 13-15

American College of Clinical Pharmacology (ACCP)
Sept. 14-15

Morgan Stanley Healthcare Unplugged Conference
Sept. 16

The 16th Annual NewsMakers in the Biotech Industry, sponsored by BioCentury.

The Arthritis Drugs Advisory Committee of the FDA will review Auxilium Pharmaceutical's(AUXL) Xiaflex for advanced Dupuytren's disease, a condition in which the tendons of the hand that help move the fingers of the hand become thickened and scarred.

FDA approval decision date for Theravance's(THRX) antibiotic Telavancin

visal 18-08-10 21:25

Calopre ma su ARYX???
Non si sa nulla???

calopre 19-08-10 09:43

FDA decision trade with double approval potential PDF | Print | E-mail
Written by Patrick Crutcher
Wednesday, 18 August 2010 19:46
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As we told our subscribers Wednesday morning, the Super Bowl of FDA decisions is coming in October, so we thought it was important to try and highlight some of the companies with the best risk-reward profiles going into October, like ALXA and AVNR.


Today we highlighted Alkermes, Inc.(NASDAQ: ALKS) and the stock rose to near 52-week highs before some profit taking at the end of the day. We believe this is definitely a low-risk and good-reward play that is well positioned going into October.

ALKS is in a unique position for a company of their size, since they have a potential double approval coming in October. They have a review panel for the sNDA for Vivitrol coming on September 16th, with a PDUFA date for Vivitrol on October 12th and another PDUFA date for Bydureon on October 22nd, both of which rely on Alkermes’ proprietary Medisorb® technology.

ALKERMES
13.94 +0.05 (+0.36%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.We should note that Bydureon is a potential blockbuster drug that utilizes ALKS’s technology and is partnered with Eli Lilly (NASDAQ:LLY) and Amylin Inc.(NASDAQ: AMLN). Bydureon is a once-weekly formulation of exenatide, the active ingredient in Byetta® (exenatide) injection, which was approved in the U.S. in June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. Byetta® has had sales of roughly $700M. Bydureon has demonstrated superior blood sugar control compared to sitagliptin, pioglitazone and insulin glargine, common diabetes medications with combined 2008 sales exceeding $8 billion. They face increasing competition from Novo Nordisk’s diabetes drug, Victoza. Ideally, this improved version could help spur more sales.

Investors should note that this is a resubmission, so approval could be more likely than “first-time” applicant drugs, since the companies have had time to fix any underlying issues. No new trials were required for Bydureon, as the FDA had issues related to finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. Additionally, ALKS has an 8% royalty off the first 40 million units of Bydureon sold each year and 5.5% after that. This could mean some serious cash for ALKS for not much work after approval.

ALKS is also trying to expand the Vivitrol with their sNDA for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence, which was designated for priority review by the U.S. Food and Drug Administration (FDA). A priority review seems fitting from the FDA given the huge problems opoid dependence has presented in recent years.

Approval in this indication would certainly expand the market potential and give ALKS more incentive in promoting Vivitrol. Lazard analyst Terence Flynn projects a $300 million market opportunity for Vivitrol in opioid dependence. Sales of Vivitrol in alcohol dependence have been slow to say the least, with sales totaled $20.2 million in the fiscal year ended March 31, 2010. Their pivotal trial in opioid dependence showed data with high statistical significance with 90% of patients treated with Vivitrol had opioid-free urine samples after 24 weeks compared to 35% of patients treated with placebo injections. Additionally, treatment with Vivitrol led to more patients completing treatment and a significantly reduction in patient-measured cravings for opioids.

They have a strong balance sheet ( $90M in cash and $400M+ in assets) for which they could live-off of for several years and a good revenue stream, but are still fighting to be cash-flow positive. They had quarterly revenues of $42.3 million, driven by strong manufacturing and royalty revenues from RISPERDAL® CONSTA®. Remember, they still have a developing pipeline with several Phase 2 and Phase 1 drugs in addiction, mental health, diabetes, pain, and rheumatoid arthritis. They have already already pushed 2 drugs through the FDA, Vivitrol and RISPERDAL® CONSTA®. This company has serious growth potential with approval of either of these drugs.

Disclosure: No Positions

calopre 19-08-10 11:31

Jazz rallies on FDA comments. ImmunoGen granted orphan status PDF | Print | E-mail
Written by BioMedReports.com Staff
Wednesday, 18 August 2010 20:06
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Below is a list of the companies that made news in the healthcare sector on Wednesday, August 18, 2010.
Jazz Pharmaceuticals Inc. (Nasdaq:JAZZ) moved higher Wednesday after the FDA said that its drug candidate for fibromyalgia appears to be effective in treating the chronic pain disorder. The drug is set to be reviewed this Friday, August 20th by an FDA review panel. After closing Tuesday's trading at $10.25, shares shot up as high as $11.90 before pulling back and settling the day at $10.61, up 36 cents or 3.51%. Shares continued higher in the after hours market.

ImmunoGen, Inc (Nasdaq: IMGN), a biotechnology company that develops antibody-based targeted anticancer products, today announced that the US Food and Drug Administration has granted orphan drug designation to its lorvotuzumab mertansine (formerly IMGN901) product candidate when used for the treatment of small-cell lung cancer (SCLC). Through a separate process, ImmunoGen has received a positive opinion for lorvotuzumab mertansine as an orphan medicinal product for the treatment of SCLC from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) and is awaiting final designation from the European Commission. The compound previously was granted orphan drug designation for the treatment of Merkel cell carcinoma in both the US and European Union (EU).

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company also announced today that the application has been granted a priority review designation by the FDA.

Hemispherx Biopharma, Inc. (AMEX:HEB) today announced that its six-year litigation battle with the South African investment conglomerate JCI Ltd., traded on the Johannesburg Stock Exchange, ended in victory August 11, 2010, with the entry of a $188 million judgment in Hemispherx's favor and against Johannesburg Consolidated Investments (JCI) and former JCI officers R.B. Kebble and H.C. Buitendag. Kebble and Buitendag used JCI Ltd. to pull off what South African authorities have called the largest financial fraud in that country's history, engaging in numerous acts of securities fraud. As stated in Hemispherx's complaint, this included the illegal attempt to take over and pillage Hemispherx.

Immunomedics, Inc. (Nasdaq:IMMU) and GE Healthcare, a business unit of General Electric Company (NYSE:GE), announced today that they have entered into a license and collaboration agreement for the evaluation of labeling technologies based on Immunomedics' patented F-18 peptide labeling method. Terms of the agreement were not disclosed, but GE Healthcare will fund all costs related to this collaboration.

Intellect Neurosciences, Inc. (OTCBB:ILNS) a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has locked the database of the Company's Phase 1b clinical trial for its lead Alzheimer's candidate, OXIGON(TM) (OX1). The Company tested OX1 for safety and tolerability in 36 healthy elderly volunteers aged 60 or more during 14 days of repeated dosing in a double blind, randomized, placebo-controlled, multiple escalating dose study. Locking of a database is done after review, query resolution, and a determination that the database is ready for analysis. Intellect is the sponsor of this trial, which was conducted by Kendle, a global clinical research organization, through the Kendle Clinical Pharmacology Unit located in Utrecht, The Netherlands. As the sponsor, Intellect takes responsibility for the initiation and management of the clinical trial.

Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the Company has requested a Type B Meeting in order to review the Company’s Phase III protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

Revolutions Medical Corporation (OTCBB:RMCP), announces detailed studies to further expand the value of its proprietary MRI imaging tools. Tom O'Brien, President of Revolutions Medical and an early pioneer in the launch of Magnetic Resonance with Johnson & Johnson's Technicare Corporation states, "30 years ago the founders and Nobel Prize winners envisioned applications of Magnetic Resonance in color where the diagnosis could be made and success of treatment could be monitored. With these first application studies we will hopefully realize that dream of the MRI founders. Future applications may be possible where we can follow hemorrhage history through clear indications as well as assess effectiveness of cancer treatments more easily through changes in color."

XOMA Ltd. (Nasdaq:XOMAD), a leader in the discovery and development of therapeutic antibodies, announced today that it has sold its royalty interest in CIMZIA(R) (certolizumab pegol) marketed by UCB S.A. for $4 million to an undisclosed buyer. The manufacture of CIMZIA is covered by a license to XOMA's Bacterial Cell Expression technology. The licensed U.S. patents will expire in 2014. CIMZIA is a pegylated antibody fragment that targets tumor necrosis factor alpha. It is approved in the U.S. to treat Crohn's disease and rheumatoid arthritis.

"The sale of our royalty interest in CIMZIA provides non-dilutive funding to support the development of XOMA 052 for Type 2 diabetes and other diseases and our preclinical programs," said Steven B. Engle, Chairman and CEO of XOMA.

Also Wednesday: 

AdvanSource Biomaterials Corporation (NYSE Amex: ASB), a leading developer of advanced polymer materials for a broad range of medical devices, today announced financial results for its fiscal 2011 first quarter ended June 30, 2010.
Advaxis, Inc., (OTC:ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has completed the nine (9) doses to be administered to the three (3) vanguard patients in the low dose group of its phase II cervical dysplasia clinical trial study.
Agilent Technologies Inc. (NYSE:A) and the Agilent Foundation today announced that Dr. Thomas Hartung has received an Agilent Thought Leader Award in support of his research for the use of toxicity pathways to predict developmental neurotoxicity.
Axxess Pharma, Inc. (PINKSHEETS: AXXE), a pharmaceutical company specializing in the marketing and distribution of both prescription and non-prescription drugs, wishes to advise shareholders and other interested parties that Senior Management has become awareof an unauthorized press release being disseminated to the public by Mina Mar Marketing Group.
Biogen Idec (NASDAQ: BIIB) and Knopp Neurosciences today announced they have entered into an exclusive, worldwide license agreement under which Biogen Idec will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, and potentially other indications.
Bohai Pharmaceuticals Group, Inc. (OTCBB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine in China, today announces the availability of a new online Investor Fact Sheet.
Celera Corporation (NASDAQ:CRA) today announced the publication of a review article on the KIF6 gene variant as a predictor of risk of coronary heart disease (CH ) and reduction of CHD events from statin therapy.
Emerging Healthcare Solutions, Inc. (Pink Sheets:EHSI) announced today that the Company has signed an option with Regenevita, owner of the right to license Neo Natal Proenitor Cell Expansion Technology in Latin America.
Martek Biosciences Corporation (Nasdaq:MATK) announced today that it intends to release the results of its third quarter of fiscal 2010 on Wednesday, September 1, 2010, at approximately 4:00 p.m. Eastern Time (ET).
Regenicin, Inc. (OTC Bulletin Board:WDSTD), a development stage biotechnology company, announced today that it has completed an initial $3.25 million funding in conjunction with its acquisition of a worldwide exclusive license to know-how technology controlled by Lonza Walkersville.
Sigma-Aldrich Corporation (Nasdaq:SIAL) is pleased to announce that Magnus Borg has been named Vice President and Chief Information Officer, effective August 16, 2010.
Smokefree Innotec, Inc. (Pink Sheets:SFIO) confirmed today the announcement by the Biotech company Cannabis Science (OTCBB:CBIS) regarding entering into a joint venture agreement to develop and market several high-tech smoke-free vaporized medical cannabis pharmaceutical products, as released by CBIS on August 13.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced it

u055884 19-08-10 19:51

scusatemi c'è qualche approvazione prevista per settembre?

il-parigino7 19-08-10 22:36

Prossime date per cycc?

calopre 20-08-10 17:26

FDA Calendar


Date Company Name Ticker Drug Event Outcome Details
10/16/2010 Ista Pharmaceuticals Inc ISTA Once-daily XiDay (sNDA) FDA action on once-daily XiDay as a treatment for ocular inflammation and pain following cataract surgery

-Market Potential


-Approved in Other Countries




10/12/2010 Alkermes, Inc. ALKS Vivitrol (sNDA) FDA decision on Vivitrol for additional indication as a treatment of opioid dependence
-Rival Drugs



-Approved in Other Countries




10/11/2010 Alexza Pharmaceuticals Inc. ALXA AZ-004 (NDA ) FDA decision on AZ-004 for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.
-Rival Drugs


-Market Potential



-News

10/03/2010 JAVELIN PHARMACEUTICALS JAV Dyloject (NDA) FDA decision on Dyloject for the management of acute moderate-to-severe postoperative pain in adults
-Rival Drugs



-Approved in Other Countries




09/17/2010 Roche Group RO.SW, ROG.SW Avastin (sBLAs) FDA to make a decision on first-line use of Avastin in combination with certain types of chemotherapy for advanced breast cancer


-Approved in Other Countries




09/16/2010 Arena Pharmaceutical Inc ARNA Lorcaserin (NDA) FDA panel to review Lorcaserin for weight management



-News

09/16/2010 Alkermes, Inc. ALKS Vivitrol (sNDA) FDA panel to review Vivitrol for additional indication of opioid dependence treatment
-Rival Drugs



-Approved in Other Countries


-News

09/14/2010 Savient Pharmaceuticals Inc SVNT Krystexxa (Amended BLA) FDA decision on Krystexxa for chronic gout in patients refractory to conventional therapy. -Drug Status



-Market Potential



-News

09/11/2010 QUESTCOR PHARMACEUTICALS INC QCOR H.P. Acthar Gel (sNDA) FDA decision on H.P. Acthar Gel for additional indication as treatment for infantile spasms -Drug Status


-Rival Drugs




-News

09/10/2010 Cumberland Pharmaceuticals Inc CPIX Acetadote (sNDA) FDA decision on Acetadote for additional indication as treatment of patients with non-acetaminophen acute liver failure


-Approved in Other Countries


-News

09/07/2010 Forest Laboratories Inc FRX Ceftaroline fosamil injection (NDA) FDA panel to review Ceftaroline for treatment of adults with community acquired bacterial pneumonia and complicated skin and skin structure infections
-Rival Drugs


-Market Potential


da lunedì si cambia musica
occhio ad QUESTCOR PHARMACEUTICALS e Alexza Pharmaceuticals Inc. ALXA


08

Avio 21-08-10 15:34

ave calopre morituri te salutant

che mi dici di uluru?
riuscira atornare a 0,14 prima di fallire?:'(

calopre 21-08-10 17:11

Citazione:

Originalmente inviato da bannavio (Messaggio 26281753)
ave calopre morituri te salutant

che mi dici di uluru?
riuscira atornare a 0,14 prima di fallire?:'(

ADDISON, Texas, Aug. 2 /PRNewswire-FirstCall/ -- ULURU Inc. (NYSE Amex: ULU) announced today that Altrazeal® Transforming Powder Dressing has been granted CE Mark Certification in all countries within the European Economic Area ("EEA").

Commenting on the CE Mark Certification for Altrazeal®, ULURU President and CEO, Kerry P. Gray stated, "The issuance of a CE Mark for Altrazeal® represents a significant milestone for the commercial expansion of our advanced woundcare product. This prestigious CE Mark designation for Altrazeal® provides the Company with significant licensing and marketing opportunities throughout the EEA. In addition, the standards required to be met for granting a CE Mark are expected to also allow ULURU to more quickly gain approval for marketing this innovative product in Asia, South America, and other territories. CE marking is mandatory for advanced wound dressings and is the necessary approval for marketing in the EEA which consists of 27 Member States of the EU and EFTA countries.

With the granting of the CE Mark, the Company is evaluating potential collaborations to rapidly launch Altrazeal® in the first European market. Assuming the successful completion of a collaboration, Altrazeal® could potentially be launched in Europe prior to year end.

About ULURU Inc.:

ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex™ Aggregate technology and OraDisc™ transmucosal delivery system. For further information about ULURU Inc., please visit our website at www.uluruinc.com. For further information about Altrazeal®, please visit www.Altrazeal.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including but not limited to statements made relating the potential to complete a collaboration in Europe, the possibility of rapidly launching Altrazeal® in Europe prior to year end, the ability to more quickly gain marketing approvals in Asia, South America and other territories, and the success of our marketing and licensing efforts. These statements are subject to numerous risks and uncertainties, including but not limited to the risk factors detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and other reports filed by us with the Securities and Exchange Commission.

queste le mie ultime informazioni su questo titolo,realizzandosi anche in parte le aspettative,potrebbe avere anche un seguito ma non è un titolo da all-in

calopre 24-08-10 11:19

RxNews Recap for 08-23-10 PDF | Print | E-mail
Written by Mary Davila
Monday, 23 August 2010 17:40
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Below is a list of the companies that made news in the healthcare sector on Monday, August 23, 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.


AdvanSource Biomaterials Corporation (NYSE Amex: ASB), a leading developer, manufacturer and seller of advanced polymer technologies and materials for a broad range of medical devices, today announced it was notified by the staff of the NYSE Amex that a review of the Company’s Form 10-Q for the period ended June 30, 2010 indicated that the Company is not in compliance with one of the NYSE Amex’s continued listing standards as set forth in Part 10 of the NYSE Amex’s Company Guide (the “Company Guide”).

Agilent Technologies Inc. (NYSE: A) announced Martin Karplus, professor emeritus, Department of Chemistry and Chemical Biology, Harvard University; and Laboratoire de Chimie Biophysique, ISIS, Université Louis Pasteur, the winner of the 2010 Russell Varian Prize.

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that the US Food and Drug Administration (FDA) has approved Alexion’s Rhode Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second source of commercial supply for Soliris® (eculizumab).

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and collaborators at The Parkinson’s Institute and the Mayo Clinic have published new research findings in the journal Public Library of Science (PLoS).

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced the publication online in Nature Medicine of new preclinical data demonstrating that AVI-6002 and AVI-6003, the respective lead therapeutic candidates against Ebola and Marburg viruses, both employing AVI's advanced PMOplus™ chemistry, provide post exposure efficacy in non-human primates.

Biomerica, Inc. (OTCBB: BMRA) announced today that it has introduced a new 15 minute consumer home test to determine allergy to dogs.

Diagnostic Imaging International Corp. (OTCBB:DIIG) ( DIIG"), owns and operates CTS, a Teleradiology company, announced today its financial results for the three- months ended June 30, 2010.

Cindy Morrissey, President and CEO of Emerging Healthcare Solutions, Inc. (Pink Sheets: EHSI), called the results of a recent study on Friday an ‘encouraging step’ towards the use of stem cells to regenerate human organs.

Encorium Group, Inc. (Nasdaq:ENCO), a full service multinational clinical research organization (CRO) conducting studies in over 30 countries for many of the world's leading pharmaceutical and biotechnology companies, today announced that it intends to commence a rights offering for up to 3,401,151 shares of its common stock.

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that it received a refusal to file letter from the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Ceplene® (histamine dihydrochloride)

GeckoSystems Intl. Corp. (PINKSHEETS: GCKO) announced today that its stock is now quoted in the U.S. over-the-counter (OTC) markets, on the Pink Sheets "Current Information" tier, under the ticker symbol GCKO.GeckoSystems is a dynamic leader in the emerging mobile robotics industry revolutionizing their development and usage with "Mobile Robot Solutions for Safety, Security and Service™."

Genzyme Corporation (NASDAQ: GENZ) announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood.

Hop-on (PINKSHEETS: HPNN) and USAcig -- Rush Limbaugh recently cited electric cigarettes for his immediate success in his quest to stop smoking tobacco products.

Huifeng Bio-Pharmaceutical Technology, Inc. (OTC Bulletin Board:HFGB), specializing in developing and producing botanical extracts and other raw materials for pharmaceuticals and food additives today reiterated its financial results for its second quarter ended June 30, 2010.

Humana Inc. (NYSE: HUM) and Availity, LLC today announced the deployment of CarePrescribe, an electronic prescribing service, at no charge to eligible physician practices in Kentucky.

Imagenetix, Inc. (OTC Bulletin Board:IAGX) announced today that based on solid bookings and sales activities in July and the first half of August that it expects its net sales for its second quarter of fiscal 2011 ending September 30, 2010, to be from $2.8 to $3.2 million, an increase of 158% to 195% compared to the first quarter of fiscal 2011 and 47% to 68% compared to the second quarter of the previous fiscal year.

InSite Vision Incorporated (OTCBB:INSV), a company developing novel ophthalmic therapeutics, today announced the initiation of a Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery.

Kendle (Nasdaq:KNDL), a leading, global full-service clinical research organization, today announced the appointment of Jeffrey M. Zucker as Senior Director and Global Head, Patient Recruitment.

Kensey Nash Corporation (Nasdaq:KNSY), a medical device company primarily focused on regenerative medicine for a wide range of medical procedures, today reported the results for its three months and fiscal year ended June 30, 2010.

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) announced today the nationwide availability of a genetic test to detect the presence of a single polymorphism within the IL-28B gene that has been reported to help predict a person’s response to certain hepatitis C virus (HCV) therapies.

Life Technologies Corporation (NASDAQ: LIFE) today announced that its Applied Biosystems™ 3500 Dx Series Genetic Analyzers, the first CE IVD-marked capillary electrophoresis system for nucleic acid analysis, are now available for sale in Australia, India, New Zealand, Singapore, and Taiwan.

MannKind Corporation (Nasdaq: MNKD) today announced that the company will supply its novel, ultra rapid acting insulin AFREZZATM (insulin human [rDNA origin]) for use in a study being conducted by the Juvenile Diabetes Research Foundation (JDRF) as part of its Artificial Pancreas Project.

Metiscan, Inc., (PINKSHEETS:MTIZ) publicly traded under the ticker symbol (PINKSHEETS:MTIZ), announced today that the Company has filed its Registration Statement on Form S-1 with the Securities and Exchange Commission (SEC).

NanoLogix, Inc. (PINKSHEETS: NNLX) The U.S. Environmental Protection Agency announced it has entered into a Cooperative Research and Development Agreement (CRADA) with NanoLogix.The Agency and NanoLogix will work to design a rapid diagnostic method to detect bacterial threats, including E.coli and Cryptosporidium in drinking and source water. Scientists from the EPA and NanoLogix will use the company's rapid detection technology as a foundation for the new process, with the goal of significantly reduced test times from those achievable with current tests.

NexMed, Inc. (Nasdaq: NEXM), backed by a revenue generating CRO business and seeking to leverage its proprietary, multi-route NexACT® drug delivery technology and internal pipeline through out-licensing arrangements and partnerships, today announced that the Israel Patent Office has issued an allowance notice for NexMed’s patent application entitled, “Topical Compositions for Prostaglandin E1 Delivery.”

Quest Diagnostics (NYSE:DGX), the world's leading provider of diagnostic testing, information and services, today announced that its Care360™ Electronic Health Record (EHR), Version 2010.1, has been inspected by the Certification Commission for Health Information Technology (CCHIT®) and is a certified EHR Module, IFR Stage 1, achieving all 14 of the requirements applied for of the 24 requirements for Eligible Providers published by the U.S. Department of Health and Human Services (HHS) in the Interim Final Rule of January 2010.

Soligenix, Inc. (OTC Bulletin Board:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Development (OPD) Program.

Taro Pharmaceutical Industries Ltd. (“Taro,” the “Company,” Pink Sheets: TAROF) today provided preliminary, unaudited and unreviewed information on its financial performance for the first half of 2010.

Wave Systems Corp. (NASDAQ: WAVX) (http://www.wave.com) today announced that Boston Medical Center's Network Security Engineer Mark Mulvaney will share his insights on the need for encryption in hospitals and discuss the fundamental differences between software- and hardware-based encryption.

Sal.Vi 24-08-10 13:10

Calopre 3Xhttp://www.finanzaonline.com/forum/i...smilies/ok.gif

calopre 25-08-10 13:30

AVI BioPharma reports positive swine flu results. Celsion drug gets FDA Fast Track PDF | Print | E-mail
Written by BioMedReports.com Staff
Tuesday, 24 August 2010 18:24
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These and other companies that made news in the healthcare sector on Tuesday, August 24, 2010 are listed below.

AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, today announced positive results from two preclinical studies evaluating the therapeutic potential of AVI-7100 against a fully virulent pandemic H1N1 virus, also known as swine flu or swine origin influenza virus. An analysis of the data from the studies demonstrated statistically significant reductions in average viral titer versus a saline control and a control with Tamiflu®, a standard of care drug. The studies of AVI-7100, which used AVI's proprietary PMOplus chemistry, were supported by the Transformational Medical Technologies program (TMT) of the U.S. Department of Defense to identify RNA-based drug candidates against pandemic H1N1 virus. The studies were undertaken as part of a rapid response exercise demonstrating TMT's ability, in partnership with AVI, to rapidly respond to a real-world emerging viral threat.
"These H1N1 results build on the significant success we've had applying our RNA-based technologies and advanced proprietary chemistries, such as PMOplus, to anti-infective therapeutic candidates," said J. David Boyle II, interim President and CEO of AVI BioPharma. "Based on these results, TMT continues to support AVI-7100, funding an accelerated IND enabling program and Phase 1 study, as well as expanded preclinical evaluation that explores AVI-7100's potential as a broad spectrum influenza therapeutic. We look forward to continuing to work closely with TMT to support our national preparedness against biological threats."

Celsion Corporation (Nasdaq:CLSN), a leading oncology drug development company, today announced that the U.S. Food and Drug Administration has designated the HEAT Study of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), as a Fast Track Development Program. ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is currently being evaluated under a Special Protocol Assessment (SPA) agreement with the FDA in a 600 patient global Phase III trial in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. With nearly 70% of patients enrolled in the trial, Celsion is targeting to complete patient enrollment by year end 2010.

"We are very pleased to receive the Agency's Fast Track Designation for ThermoDox," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Fast Track Designation is an acknowledgement that HCC is a significant unmet medical need representing a life threatening disorder. It also recognizes the challenges facing pharmaceutical companies to develop effective new treatments for this difficult disease. Together with the FDA's SPA agreement, granting accelerated review for the HEAT Study, the Fast Track status provides Celsion with the shortest time to approval. Supported further by the National Cancer Institute's recent designation of the HEAT Study as a Priority Clinical Trial, it is clear that the major U.S. healthcare agencies and the liver cancer medical community recognize the potential of ThermoDox. We look forward to working with the FDA and other regulatory agencies around the world to make ThermoDox available to patients as soon as possible."

3SBio Inc. (Nasdaq:SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products and Isotechnika Pharma Inc. (TSX:ISA.to), a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, today announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases.

Under the terms of the agreement, Isotechnika will grant 3SBio exclusive rights to all transplant and autoimmune indications of voclosporin in China, including Hong Kong and Taiwan, excluding ophthalmic indications and medical devices which were previously licensed to Lux Biosciences, Inc. and Atrium Medical Corporation, respectively. 3SBio will be responsible for the clinical development, registration and commercialization of voclosporin in China. Isotechnika will provide, under separate agreement, commercial supply to 3SBio on a cost-plus basis. Isotechnika will receive an upfront non-refundable licensing payment of US$1.5 million. Isotechnika will also receive ongoing royalties based on sales of voclosporin by 3SBio.

3SBio will invest the US$4.5 million in Isotechnika through a three-year convertible debenture which will pay interest of 7% payable semi-annually. Isotechnika has the option to pay interest in cash or to issue new shares at the prevailing price when the interest is payable. 3SBio has the right to convert the debenture at any time into common equity of Isotechnika at a conversion price of C$0.155 per share. At maturity, any remaining balance will be paid by the issuance of common shares at a price of C$0.155 per share. 3SBio will also nominate one member to Isotechnika's Board of Directors.

Advanced Cell Technology, Inc. ("ACT"; OTCBB:ACTC) commented today on yesterday’s federal court ruling, temporarily blocking federal funding for embryonic stem cell research involving the destruction of embryos. The company believes that this will add to the pressure on the NIH to find appropriate sources of human ES cells that can be funded in the context of this preliminary injunction. It is notable, then, that ACT’s proprietary "embryo-safe" Single Blastomere technique for deriving human embryonic stem cells (hESCs), documented in Nature and CELL Stem Cell magazines and elsewhere, does not require destruction of the embryo and as a consequence may not be directly affected by this ruling. ACT does not rely on government funding for any of its research or product development. Accordingly, there is no current impact on the company’s business.

AGA Medical Holdings, Inc. (Nasdaq: AGAM) today announced that it has filed a patent infringement lawsuit against W.L. Gore & Associates (Gore). AGA Medical is alleging that Gore is infringing AGA Medical’s U.S. Patent No. 5,994,738 which covers certain transcatheter occlusion products for the treatment of structural heart defects. AGA Medical is seeking damages against Gore and a permanent injunction prohibiting them from manufacturing and selling the Gore HELEX Septal Occluder both in the United States and abroad.

Cerus Corporation (NASDAQ: CERS) announced today that it has signed an agreement to acquire BioOne Corporation's commercialization rights for the INTERCEPT Blood System for platelets and plasma, subject to approval of the transaction by BioOne’s shareholders. In 2004 and 2005, Cerus and its partner at the time, Baxter International, licensed the commercialization rights for INTERCEPT platelets and plasma to BioOne for an Asian territory, which included China, Japan, Taiwan, Singapore, Korea, Thailand and Vietnam. Cerus holds the commercialization rights for the INTERCEPT red blood cell system for this region.

Under terms of the agreement, BioOne will receive approximately 1,170,000 shares of Cerus’ common stock valued at approximately $3.08 per share, and Cerus will relinquish its equity interest in BioOne.

"We believe there is great market potential for INTERCEPT in Asia and that regaining the platelet and plasma rights from BioOne will allow us to pursue a different business strategy and potential partnerships for all three programs," said Claes Glassell, Cerus' president and chief executive officer.

TomoTherapy Incorporated (NASDAQ:TOMO), maker of advanced, integrated radiation therapy solutions for cancer care, announced today that General Hospital of Guangzhou Military Command of PLA has purchased the first TomoTherapy® radiation therapy system to be installed in Southern China. The TomoTherapy treatment system will enable the hospital to provide advanced cancer care to a wide variety of patients, including those with head and neck cancers.

"In this area of Southern China, we see a large number of patients who suffer from head and neck cancers. But our aging linear accelerator technology has limited our ability to treat these patients, forcing us to refer them to other cancer centers," said Jian Liu, president of PLA Guangzhou Hospital, which treats more than 1 million patients annually. "The TomoTherapy platform will enable us to expand our care and deliver treatments for the most complicated cases very effectively and accurately with its integrated daily 3-D imaging."

Vyteris, Inc. (OTC.BB:VYTR), developer of the first FDA-approved active transdermal patch and a leader in alternative drug delivery technology, today announced an agreement with the Georgia Tech Research Corporation of the Georgia Institute of Technology (Georgia Tech) granting Vyteris the option to exclusively license Georgia Tech's patented thermal ablation and microdevice fabrication technologies for transdermal drug delivery.

The thermal ablation technology is designed to selectively enhance skin permeation to allow delivery of therapeutic drugs of high molecular weight, including peptides and proteins, through the skin, eliminating the need to inject or infuse such drugs with hypodermic needles. The microdevice fabrication technology provides a novel method to manufacture microstructures for drug delivery using mild conditions that do not harm encapsulated drugs. Vyteris plans to work closely with Georgia Tech to identify therapies that would be appropriate for the application of the new technologies.

Also Tuesday:

calopre 25-08-10 13:32

AbTech Holdings, Inc. (OTCBB: ABHD) is pleased to advise that AbTech Industries, Inc., a leading environmental technologies firm and creator of the EPA-approved Smart Sponge® water filtration technology, has just announced that based on a scientific and peer review by the U.S. Coast Guard, AbTech's passive skimmer, absorbent boom and portable filtration applications were recently assessed as potentially beneficial to the Deepwater Horizon Response effort.

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, announced that its Director of Chemistry and Quality, Dr. Ric Zarzycki will give an invited presentation today on the Company's Cobalamin nanoparticle technology at a thought-leadership symposium being held at the American Chemical Society's ("ACS") 240th National Meeting & Exposition, at Boston Convention and Exhibition Center in Boston, Massachusetts, August 22-26, 2010.

Accelrys, Inc. (NASDAQ: ACCL), the leading scientific informatics software and services company, today announced the release of Symyx Notebook 6.5 by Accelrys.

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced plans to seek additional government funding for development of its novel, once-daily antibiotic, Restanza™ (cethromycin) based on a new, high-profile report from the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response recommending independent investment in small innovator companies developing potentially life-saving medical countermeasures.

AdvanSource Biomaterials Corporation (NYSE Amex: ASB), a leading developer of advanced polymer materials for a broad range of medical devices, today announced hat the Company has entered into a multi-year supply agreement with a leading multi-national medical device company.

The Amergence Group (PINKSHEETS: AMNG), a company that focuses on developing, nurturing, and rapidly expanding selected emerging or disruptive companies across a wide range of industries and disciplines, announced today that its strategic partner,Altitude Organic Licensing Corp., has licensed its proprietary AO brand to five retail locations.

Baxter International Inc. (NYSE: BAX) today announced a definitive agreement with Kamada Ltd. for exclusive commercial rights to GLASSIA™ [Alpha 1-Proteinase Inhibitor (Human)], the first and only liquid alpha1-proteinase inhibitor, in the United States, Australia, New Zealand and Canada.

Bederra Corporation (PINKSHEETS: BEDA), a Houston, Texas-based, diversified medical services provider, discusses recent events in detail.

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data has been published in the Annals of Neurology on an investigational, two-step assay to detect anti-JC virus (JCV) antibodies in human serum and plasma.

Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and other innovative technologies, today announced that Dr. Hars ini Mukundan, Scientist at Los Alamos National Laboratories ("LANL") will present a video webinar on the Integrated Optical Biosensor Development (IOBS) technology developed at LANL.

Dyadic International, Inc. ("Dyadic") (Pink Sheets:DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of specialty enzyme products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, today announced that it has completed a private placement of $3,000,000 in convertible subordinated secured promissory notes (the "Notes") with two investors.

Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company's Board of Directors appointed John E. Niederhuber, M.D. as a Class III Director for a two-year term that will expire at the 2012 annual meeting of stockholders.

Life Technologies Corporation (Nasdaq:LIFE), a provider of innovative life science solutions and SG Biofuels, Inc., a bioenergy crop company, today announced they have completed sequencing the Jatropha curcas genome to 100x coverage, using the SOLiD™ 4.0 System by Life Technologies.

Marina Biotech, Inc. (NASDAQ: MRNA), a leading RNAi-based drug discovery and development company, today announced that the U.S. Patent and Trademark Office has issued patent U.S. 7,780,983 covering processes for preparing amphoteric liposomes or SMARTICLES®.

MMRGlobal, Inc. (OTCBB: MMRF) through its subsidiary, MyMedicalRecords, Inc, a leading provider of Personal Health Records (PHR) technology and professional document management and imaging systems,today announced the signing of a distribution agreement with Image Access Corporation, Kodak's largest reseller of document imaging products and services.

Omni Bio Pharmaceutical, Inc. ("Omni Bio"), (OTCBB: OMBP) today announced that it has executed a two-year contract with the University of Colorado Denver (UCD)-Anschutz Medical Campus, in collaboration with researchers at National Jewish Health, to further evaluate the biological activity of Alpha-1 antitrypsin (AAT) and its effects on influenza. Omni Bio will pay UCD approximately $440,000 under the agreement.

PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that its Board of Directors has authorized the repurchase of up to $25 million of the Company's common stock.

Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that it has secured key PBT2 patents in Europe and the United States.

Pro-Pointer, Inc. (PINKSHEETS: PPII), through its wholly-owned subsidiary Coenzyme-A Technologies, Inc.,proudly announces today the introduction of their latest Nutraceutical development, the "MODULATOR MATRIX I" formula, especially designed to help the individual user to effectively cope with today's Stress and Anxiety Syndromes.

Regenicin, Inc. (OTC Bulletin Board:WDSTD), a clinical-stage biotechnology company, announced today that Dr. Joseph Rubinfeld, one of the four original founders of Amgen, Inc., has agreed to join the company's board of directors.

Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire Pharmaceuticals Inc. received a ruling from the FDA on its Citizen's Petition relating to Pentasa.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the first patient has been treated in its clinical trial of STA-9090 in combination with docetaxel for the treatment of advanced solid tumor malignancies.

Warner Chilcott plc (Nasdaq:WCRX) today announced that it has received the Food and Drug Administration's ("FDA's") response to a citizen petition it had filed regarding its ASACOL and ASACOL HD products.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Judge’s decision has broad implications for generic versions of biologic drugs and companies who make them PDF | Print | E-mail
Written by Patrick Crutcher
Wednesday, 25 August 2010 02:23
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A judge’s decision will have vast implications for some of the biosimilar companies in the healthcare sector.

Shareholders of Sanofi-Aventis (NASDAQ:SNY) and Momenta Pharmaceuticals (NASDAQ:MNTA) are anxiously awaiting a judge’s decision on whether to block the sale of a generic version of SNY’s blockbuster Lovenox. This comes after MNTA gained FDA approval for their generic version of Lovenox, a biologic-like blood thinner, and SNY later sought a temporary restraining order and preliminary injunction directing the FDA to suspend and withdraw its approval of MNTA’s generic version. Many were caught off guard, since this was the first approval of a generic version of a complex-drug like Lovenox in over 10 years.


Biosimilars: Data Exclusivity and the "Patent Protection Gap"

Sanofi Bid to Block Lovenox Generic Taken `Under Advisement' by U.S. Judge

To be specific, biosimilars or follow-on biologics are essentially generic versions of biologic drugs. Essentially, biologics are genetically engineered proteins derived from genes(human, animal, micro-organism) and involve some type of biological process to produce the medicinal product. As you can tell, these are incredibly complex-drug process, which are vastly different from creating copycat versions of typical drugs that usually only involve chemical processes. This is why the significance of MNTA’s approval is shaking the market and causing SNY to seek legal action.

The implications for MNTA and other biosimilar companies are far reaching and complex. If the judge throws out the case, MNTA and their partner Sandoz of Novartis (NASDA:NVS) will be cleared to compete with Lovenox, which had worldwide sales of $4 billion and 60% of that was in the US. They are planning on selling their generic version at roughly 30-35% less than Lovenox’s price. MNTA also has a great pipeline full of other potential blockbuster biosimilars, so they want all the cash they can get to pay their development. MNTA has another biosimilar awaiting FDA approval – M356(partnered with Sandoz), which is a biosimilar of TEVA’s $2.8 billion blockbuster Copaxone. Additionally, they have M118, a novel anti-coagulant for patients with acute coronary syndrome and M402, a novel preclinical anti-cancer compound with anti-metastatic properties and low anticoagulant activity.

This will also set precedence for other biosimilar type companies seeking to compete with other blockbuster drugs that are close to coming off patent protection, in particular, Teva’s (NASDAQ:TEVA) $2.8 billion blockbuster Copaxone and Amgen’s Procrit/Epogen and Enbrel which had US sales of over $6.5 billion. These will certainly be main targets in the follow-on biologics war that is coming and other big pharmas have taken notice. In late 2009, Insmed Inc.(NASDAQ:INSM) sold off their follow-on biologics unit to Merck (NASDAQ:MRK) for $123M. A positive result from the case could also lead to more mergers and acquisitions in this biotech area, since some of the larger pharmas have expressed great interest in this area. Pfizer has expressed great interest in this area and Teva Pharmaceutical (Nasdaq: TEVA), Novartis (NYSE: NVS), and Hospira (NYSE: HSP) already have approvals in the European Union for biogenerics. Companies like Protalix BioTherapeutics Inc. (AMEX: PLX), Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), PROLOR Biotech Inc. (AMEX: PBTH), Intellipharmaceutics (NasdaqCM: IPCI), and even iBio, Inc. (OTC: IBPM.OB) would certainly benefit from a positive opinion on the case. These companies pipelines and prospects would certainly warrant further attention from large pharmas.

A positive ruling for SNY would certainly send MNTA back down to the $10 range, since their future would be tied up in the courts. It would also cast into doubt a clear approval pathway for biosimilars, since the Pathway for Biosimilars Act of 2009 and Patient Protection and Affordable Care Act of 2010 would certainly come into question under U.S. Judge Emmet Sullivan’s ruling, if SNY were favored in the case.

The judge claims that he plans on delivering a decision soon. I imagine most investors in MNTA or SNY are wound tight, since it is not clear which way he is leaning on the issue. MNTA and SNY also have to worry about TEVA being close on their generic version of Lovenox, which I am sure will be stalled until a decision is made. One thing is for sure, either big pharma wins or biosimilars are on the way.


Disclosure: No positions.

mazzam 25-08-10 15:06

http://www.cnanalyst.com/2010/08/top...g-24-2010.html

saluti.

calopre 26-08-10 09:26

RxNews Recap for 08-25-10 PDF | Print | E-mail
Written by BioMedReports.com Staff
Wednesday, 25 August 2010 16:52

Below is a list of the companies that made news in the healthcare sector on Wednesday, August 25, 2010.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.
AdvanSource Biomaterials Corporation (NYSE Amex: ASB), a leading developer, manufacturer and seller of advanced polymer technologies and materials for a broad range of medical devices, today announced that it has received a “Notice of Allowance” from the U.S. Patent and Trademark Office in connection with its antimicrobial patent application filed in June 2007.
Bioanalytical Systems, Inc. (NASDAQ:BASI) announces that Alberto Hidalgo has joined the Company as Vice President - Business Development and Marketing effective August 18, 2010.
Bohai Pharmaceuticals Group, Inc. (OTCBB/OTCQB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, today announces the launch of a new corporate website for U.S. investors.
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) report that preliminary results from the Phase 3 AVERROES clinical trial of the investigational drug apixaban compared with acetylsalicylic acid (ASA, or aspirin) in patients with atrial fibrillation expected to be or demonstrated to be unsuitable for warfarin therapy will be presented at the European Society of Cardiology Congress 2010.
Celgene Corporation (NASDAQ: CELG) today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules.
Emergent BioSolutions Inc. (NYSE:EBS) today hosted "Looking Beyond the Bench," a symposium organized for doctoral students enrolled in the NIH-Oxford-Cambridge Scholars Program.
HIV-VAC, Inc. (PINKSHEETS: HIVV) Kevin Murray, its President, announced today that HIV-VAC has entered into a definitive agreement to acquire 80% of the outstanding voting common stock of "Richard y Lange S.A. De C.V.," a Mexican corporation for the consideration of the issuance of 8,000,000 HIV-VAC common shares.
ImageXpres Corporation (PINKSHEETS: IMJX) today reported strong second quarter financial results and provided an optimistic forecast for the second half of 2010.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today it has entered into an Amended and Restated License, Development and Marketing Agreement with Allergan, Inc., which revises terms related to the PROLACRIA™ (diquafosol tetrasodium ophthalmic solution) 2% development program and Inspire's right to receive revenues from Allergan based on net sales of RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% and any other human ophthalmic formulations of cyclosporine owned or controlled by Allergan.
Metiscan, Inc. (PINKSHEETS: MTIZ), the parent company of a portfolio of enterprises with operations in healthcare, healthcare IT, mobile technology and employment services, today announces results for its second quarter ending June 30, 2010.
mPhase Technologies, Inc. (OTCBB: XDSL), a leader in the development of Smart Surfaces and Advanced Battery Technologies announced today that it has signed a representative agreement with Tritech Ltd.of Hod HaSharon, Israel.Tritech Ltd. http://www.tritech.co.il is a leading stocking representative and distributor of major manufacturers of electronic components serving the Military, Communication, Medical, Industrial Control and Security Industries.
NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company with operations in the U.S. and China, commented today on the ruling this week of a U.S. District Court blocking the federal government from funding research involving human embryonic stem cells.
Neuralstem, Inc. (NYSE Amex:CUR) announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells.
NexMed, Inc. (Nasdaq: NEXM), backed by a revenue generating CRO business and seeking to leverage its proprietary, multi-route NexACT® drug delivery technology and internal pipeline through out-licensing arrangements and partnerships, today announced that Dr. Bassam Damaj, President and Chief Executive Officer, will present at the Rodman & Renshaw 12th Annual Healthcare Conference at 10:25am ET on Tuesday, September 14, 2010, in the Winslow Salon on the 5th floor of the New York Palace Hotel in New York City.
PharmingGroup NV ("Pharming"or "the Company") (NYSE: PHARM) today announced that t intends to submit the Biologic License Application (BLA) to the US Food and Drug Administration(FDA) to obtain marketing approval for Rhucin® for the treatment ofacuteangioedemaattacksinpatients withHereditary Angioedema (HAE). Followingpre-BLAdiscussionswith theFDA,Pharmingis preparing the BLA dossierfor submission towards theend of this yearbut no later than January 2011.
PPD, Inc. (Nasdaq: PPDI) today announced it has named Neil McCullough, Ph.D., as vice president of quality management systems. In this role, Dr. McCullough will provide strategic direction for quality management across all lines of business and ensure full compliance with global regulations guiding the biopharmaceutical industry.
Prana Biotechnology (NASDAQ:PRAN) announced it has secured key PBT2 patents in Europe and the United States.
Pro-Pointer, Inc. (OTC:PPII), through its wholly-owned subsidiary Coenzyme-A Technologies, Inc.,proudly announces the introduction of their latest Nutraceutical development, the "MODULATOR MATRIX I" formula, especially designed to help the individual user to effectively cope with today's Stress and Anxiety Syndromes.
Senomyx, Inc. (NASDAQ: SNMX), a leading company focused on using proprietary taste receptor technologies to discover and develop novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that Gwen Rosenberg, the Company's Vice President, Investor Relations & Corporate Communications, will present a corporate overview on Tuesday, August 31, 2010 at 3:20 p.m. Central Time (4:20 p.m. Eastern Time) during the Midwest IDEAS Investor Conference.
SensiVida Medical Technologies (PINKSHEETS: SVMT), a developer and provider of minimally invasive diagnostic technologies and devices, announced today that it has contracted with MDC Associates to conduct clinical studies and prepare the 510k submission for SensiVida's allergy test system.
Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX) today announced that Somaxon and Procter & Gamble (NYSE:PG) have entered into a co-promotion agreement for Silenor® (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.
XTend Medical Corporation (PINKSHEETS: XMDC), a company that specializes in delivering life-changing medical technology to healthcare organizations globally, has begun lining up manufacturers and software developers to commercialize the BioHarp Medical Device.
Pharmacy and football are joining forces in New York City as Walgreens (NYSE: WAG)(NASDAQ: WAG), the nation's leading provider of pharmacy, health and wellness services, today announced a strategic alliance with the New York Giants as the team's official retail pharmacy.
ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced enrollment has been completed in the Phase 2b clinical trial with PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV) infection.

calopre 26-08-10 18:04

Chelsea Therapeutics' trial protocol for experimental rheumatoid arthritis drug gets FDA nod PDF | Print | E-mail
Written by Staff and Wire Reports
Thursday, 26 August 2010 09:52
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As we told our readers last Friday, Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) was set to run higher in anticipation of FDA news.

This morning, the company has announced that the U.S. Food and Drug Administration (FDA) has approved the trial protocol for its experimental rheumatoid arthritis drug and it plans to start patient screening for the mid-stage trial in September.
The mid-stage trial will test the safety and efficacy of the drug CH-4051, in 250 patients against methotrexate (MTX), a common chemotherapy drug that is also used to treat autoimmune disorders like rheumatoid arthritis and psoriasis.

"Although MTX is considered the standard of care in RA, both as a monotherapy and in combination with other RA treatments, the dosing and maximal therapeutic benefit of MTX is limited by well-documented tolerability issues, long-term safety concerns and variable bioavailability," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "Given that CH-4051 is metabolically stable and that all of our preclinical and clinical work suggests enhanced absorption, dramatically increased potency and improved tolerability over MTX, we believe CH-4051 will be safe and highly efficacious in a historically treatment-resistant patient population."


Chelsea Therapuetics set to run higher in anticipation of upcoming FDA decision

Bullish and Bearish Signals in Healthcare

The stock has been climbing higher, from a fundamental standpoint, off news that the the FDA is poised to pull ProAmitine (Midodrine) from the market due to Shire (SHPGY) not conducting post-approval studies to prove that the drug has a benefit. Shire confirmed they have elected to withdraw the product effective September 30, 2010.

The withdrawal of Shire’s drug would also stop all sales of any generic version. These generic companies include Mylan Pharmaceuticals (MYL), Impax Laboratories (IPXL), and Novartis (NVS) unit Sandoz, must stop selling their generic versions of Midodrine. About 100,000 U.S. patients filled prescriptions for brand or generic forms of ProAmatine in 2009, the FDA said. Why does this matter to CHTP? With all of the competition removed, CHTP’s lead drug, Northera, will have a substantially larger market to fill, if approved. Some analysts have projected the market size for their drug to be around $200-300M.

Investors are anxiously awaiting news from CHTP’s pivotal Phase 3 trial with results due in September for their lead drug, Northera (droxidopa), for the treatment of orthostatic hypotension. Study 301 was reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA) in February 2008. The FDA subsequently confirmed that the SPA remained in effect following the protocol amendments approved by the FDA late last year, after their Study 302 did not meet the primary endpoint, yet did very well in other endpoints.

Shares of the company, which have risen over 26 percent in the last seven trading sessions, are rising again this morning. As more investors become aware of these developments, the trend should continue.

alex1664 27-08-10 23:38

calopre mi hanno segnalato questa:

la conosci?

IVAX Diagnostics

calopre 28-08-10 00:07

tratta reagenti e poco altro, circa 200 prodotti, voglia di espansione con conseguenti costi.
poco trattata 15 milioni di capitalizzazione circa
non so, se magari ci fai sapere a che pro ti è stata segnalata.
exas
alxa
arna
credo siano più interessanti

il-parigino7 28-08-10 00:24

conosci le date buone x cycc?

calopre 28-08-10 11:45

ImmunoGen sinks on cancer drug setback PDF | Print | E-mail
Written by BioMedReports.com Staff
Friday, 27 August 2010 16:57

Below is a list of the companies that made news in the healthcare sector on Friday, August 27, 2010.


ImmunoGen, Inc (Nasdaq: IMGN), a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010. Genentech also stated that as planned, it will continue with its ongoing Phase III registrational T-DM1 trial, known as EMILIA, and that it will continue to work with the FDA and expects to submit a new T-DM1 BLA in mid-2012.

Genentech noted that in its review of the BLA, the FDA stated that the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population. Genentech re-affirmed its confidence in T-DM1 as "an important, novel HER2-targeted medicine," and indicated that it remains fully committed to its ongoing development. In particular, as noted above, it intends to continue the EMILIA study which compares T-DM1 to lapatinib in combination with capecitabine in people with advanced, HER2-positive breast cancer whose disease has worsened after receiving initial treatment.

"It is a significant disappointment that there will be a delay in the opportunity for T-DM1 to be approved for patients with advanced HER2 positive breast cancer," commented Daniel Junius, President and CEO of ImmunoGen. "In the meantime we continue to focus on the development of our robust and expanding pipeline as well as advancing our technology through new partnerships."

Shares of ImmunoGen fell $3.23 or 38.50% to $5.16.

Also Friday:

BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser company, is pleased to announce the appointment of Federico Pignatelli as Executive Chairman effective August 24, 2010.

Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has implemented an accelerated stock repurchase (ASR) program to repurchase $300 million of common stock, as part of its previously announced authorization from its Board of Directors to repurchase up to $500 million of common stock.

Exactech, Inc. (NASDAQ:EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today the acquisition of several innovative spine product lines and all related technology from VertiFlex, Inc. a leading developer of minimally invasive and motion preserving spinal surgery technologies.

GeoVax Labs, Inc. (OTC Bulletin Board:GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, today announced the results of its Annual Shareholders Meeting, held on August 24, 2010.

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany.

LC LUXURIES LIMITED (PINK SHEETS:LLUX) announces that its newly established subsidiary, U.S. Cannabis, Inc., a Nevada corporation, will begin supporting the U.S. medical marijuana market through the management of medical clinics in California.

MOCON, Inc. (Nasdaq: MOCO) announced today that on August 26, 2010, its Board of Directors declared a quarterly cash dividend of nine and one-half cents ($0.095) per share, payable on November 19, 2010, to shareholders of record on November 5, 2010.

Orexigen® Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that on August 25, 2010 the Compensation Committee of the Company's Board of Directors approved the grant of inducement stock options to purchase a total of 10,000 shares of common stock to two new employees.

PPJ Enterprise (PPJ) (PINKSHEETS: PPJE) a leader in proprietary automated health care reimbursement cycle (all specialties), online health information digital systems and practice information management digital system software for health care and general businesses worldwide, has announced that its subsidiary, Professional Billing Service (PBS), has exceeded its gross revenue over $85,000 during the first 26 days in August of 2010.

Avio 28-08-10 12:19

Citazione:

Originalmente inviato da bannavio (Messaggio 26281753)
ave calopre morituri te salutant

che mi dici di uluru?
riuscira atornare a 0,14 prima di fallire?:'(

sempre peggio:wall:

calopre 28-08-10 15:08

Citazione:

Originalmente inviato da bannavio (Messaggio 26344670)
sempre peggio:wall:

mi ero aggregato a voi su questo titolo pensando fosse venuto il momento per un rimbalzo invece ho riscontrato inaffidabilità e difficoltà nella gestione ordini per questo ho preferito rinunciare ad un eventuale guadagno e con non poche difficoltà (impossibile fissare un prezzo me ne hanno venduto 85)il resto ho dovutto aspettare che ci fossero delle richieste adeguate al fine di limitare i danni e ho venduto ripiegando su alxa

calopre 28-08-10 15:19

In additional to Alexza's current 6 product candidates currently with INDs and clinical trials, there are 5 other compounds that haven't been publicly announced that are viable for use of the Staccato System, which Alexza is currently eventuating (along with other compounds).

Alexza has 5 other product candidates that have completed some level of clinical trials. These product candidates are AZ-001 (Staccato Prochlorperazine), AZ-104 (Staccato Loxapine; used for migraine headaches), AZ-002 (Staccato Alprazolam), AZ-003 (Staccato Fentanyl) and AZ-007 (Staccato Zaleplon). Alexza has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato Prochlorperazine) and has completed two Phase 2 studies with AZ-104 (Staccato Loxapine, low-dose). Both product candidates are being developed for the acute treatment of migraine headache. AZ-002 (Staccato Alprazolam) has completed Phase 1 testing and one Phase 2a proof-of-concept clinical trial. *Product candidates that have completed Phase 1 testing are AZ-003 (Staccato Fentanyl) for the treatment of breakthrough pain and AZ-007 (Staccato Zaleplon) for the treatment of insomnia. Alexza is also beginning development of Staccato Nicotine for to use of smoking cessation.

"MOUNTAIN VIEW, Calif., Aug. 26 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA - News) announced today that it has licensed its Staccato nicotine technology to Cypress Bioscience, Inc. (Nasdaq:CYPB - News). The Staccato nicotine technology is a novel electronic multidose delivery system designed to help people stop smoking. The Staccato nicotine technology is intended to improve on a well-validated smoking cessation approach by delivering nicotine via inhalation, mimicking the nicotine effects of smoking without the harmful side effects associated with cigarettes.

"The Staccato system is a broad technology platform and Alexza has more Staccato-based product candidates than we can currently afford to develop on our own. In early July, we outlined our strategy to advance Staccato-based product candidates into development through self-funding and through collaborations," said Thomas B. King, Alexza President and CEO. "Today's announcement of the licensing of our Staccato nicotine technology to Cypress, along with our recently announced plans to advance AZ-007 (Staccato zaleplon) into Phase 2 clinical development, are examples of our execution of this dual-tracked development strategy."

Financial Information

According to the terms of the agreement, Cypress will pay Alexza an upfront payment of $5 million to acquire the worldwide license for the Staccato nicotine technology. In addition, following the completion of certain preclinical and clinical milestones relating to the Staccato nicotine technology, Cypress will be obligated to pay to Alexza an additional technology transfer payment of $1 million. Alexza will have a carried interest of 10% (subject to adjustment in certain circumstances) in the net proceeds of any sale or license by Cypress of the Staccato nicotine assets and the carried interest will be subject to put and call rights in certain circumstances.

Under the agreement, Cypress has responsibility for preclinical, clinical and regulatory aspects of the development of Staccato nicotine, along with the commercialization of the product. Alexza will execute a defined development plan for Cypress, culminating with the delivery of clinical trial materials for a Phase 1 study with Staccato nicotine. "


Ran up to $3.00 on news and then sank back down. Not the biggest news, but still worth noting I suppose.

calopre 28-08-10 15:25

Citazione:

Originalmente inviato da il-parigino7 (Messaggio 26343579)
conosci le date buone x cycc?

purtroppo no, mi dispiace
sono entrati a metà giugno diversi istituzionali,da seguire,da troppo tempo in un range troppo ristretto. mi aggiorni sulla pipeline. grazie
alxa comunque il titolo per prossimi due mesi
http://seekingalpha.com/article/2210...g?source=yahoo

Avio 28-08-10 19:47

Citazione:

Originalmente inviato da calopre (Messaggio 26345286)
mi ero aggregato a voi su questo titolo pensando fosse venuto il momento per un rimbalzo invece ho riscontrato inaffidabilità e difficoltà nella gestione ordini per questo ho preferito rinunciare ad un eventuale guadagno e con non poche difficoltà (impossibile fissare un prezzo me ne hanno venduto 85)il resto ho dovutto aspettare che ci fossero delle richieste adeguate al fine di limitare i danni e ho venduto ripiegando su alxa

effettivamente l'iserimento e raccolta ordini è alquanto misterioso se non sospetto alemno per me?

con fineco mi da un totale di 140k ad esempio e invece ne scambia 1 mln per esempio:mmmm:

alex1664 29-08-10 00:32

Citazione:

Originalmente inviato da calopre (Messaggio 26343505)
tratta reagenti e poco altro, circa 200 prodotti, voglia di espansione con conseguenti costi.
poco trattata 15 milioni di capitalizzazione circa
non so, se magari ci fai sapere a che pro ti è stata segnalata.
exas
alxa
arna
credo siano più interessanti


IVAX Diagnostics (AMEX: IVD)

Market Cap: 15.24M
Price: 0,55 $

Shares Outstanding: 27.65M --(18 M Shares held by Insiders)
Float: 7.50M


Dr. Struby continued, “Our efforts with respect to our 510(k) premarket submission filing with the U.S. Food and Drug Administration for the Mago® 4S, our next-generation fully automated ELISA system for autoimmune and infectious disease testing, are progressing, and we continue to expect to receive regulatory approval from the FDA and launch the product during the fourth quarter of 2010. Following the receipt of all required regulatory approvals and the subsequent commercial launch of the product, we expect the Mago® 4S will provide a flexible, efficient and cost-effective solution to high-performance laboratories, and will be our primary platform for marketing our kits in the U.S.”

dorotheum 29-08-10 01:37

Citazione:

Originalmente inviato da bannavio (Messaggio 26346307)
effettivamente l'iserimento e raccolta ordini è alquanto misterioso se non sospetto alemno per me?

con fineco mi da un totale di 140k ad esempio e invece ne scambia 1 mln per esempio:mmmm:

per avere volumi alquanto esatti e book devi spendere ed abbonarti a siti a pagamento.

senza pagare non ottieni info su volumi,ordini e book.

non c'è nulla di misterioso :bye::bye:

calopre 29-08-10 13:07

Another promising run-up play for October is Alexa Pharmaceuticals and its lead candidate AZ-004, which is an inhalation product candidate for the rapid treatment of agitation in patients with schizophrenia or bi-polar disorder. It has a PDUFA date of October 11th, 2010.

About Alexza

Alexza Pharmaceuticals is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza’s technology, the Staccato(R) system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.

AZ-004 (Staccato loxapine) is Alexza’s lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials, submitted a New Drug Application submission in December 2009, and has a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. In February 2010, Alexza established a partnership with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 in the U.S. and Canada.

Alexza has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato prochlorperazine) and has completed two Phase 2 studies with AZ-104 (Staccato loxapine, low-dose). Both product candidates are being developed for the acute treatment of migraine headache.

AZ-002 (Staccato alprazolam) has completed Phase 1 testing and one Phase 2a proof-of-concept clinical trial. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. More information, including this and past press releases from Alexza, is available online at http://www.alexza.com.

Financials

From Alexza’s most recent 10-Q filing with the SEC (5/10/10)

As of March 31, 2010, we had $41.0 million in cash, cash equivalents and marketable securities. In May 2010, we borrowed an additional $15 million. Our cash and marketable securities balances are held in a variety of interest bearing instruments, including obligations of U.S. government agencies, high credit rating corporate borrowers and money market accounts. Cash in excess of immediate requirements is invested with regard to liquidity and capital preservation….

We believe that with current cash, cash equivalents and marketable securities along with interest earned thereon, borrowings under the Hercules loan agreement, the proceeds from option exercises and purchases of common stock pursuant to our Employee Stock Purchase Plan, we will be able to maintain our currently planned operations through the second quarter of 2011 and will extend into 2012 if we achieve the eligible milestones under the Biovail collaboration during the next 12 months. Changing circumstances may cause us to consume capital significantly faster or slower than we currently anticipate. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available financial resources sooner than we currently expect.

Trading Method

ALXA seems to be another perfect candidate for the run-up method. I already have a small position, however I look to increase my holdings as we get closer to July-August. My target run-up price for ALXA is $8 per share. Before a series of dilutions ALXA was trading at nearly $13 a share when it announced its positive results from the Phase 2b study of AZ-004. My advice on this one is to get in early and hold until a few weeks out from the FDA date.

Enjoy.

Disclosure

Long ALXA POSTATO A LUGLIO

calopre 29-08-10 13:12

MOUNTAIN VIEW, Calif., Aug 05, 2010 /PRNewswire via COMTEX/ -- Alexza Pharmaceuticals, Inc. /quotes/comstock/15*!alxa/quotes/nls/alxa (ALXA 3.00, +0.16, +5.63%) today announced that it has entered into definitive agreements with a select group of institutional investors to raise approximately $18.0 million in gross proceeds in a registered direct offering through the sale of common stock and warrants. The Company agreed to sell a total of 6,685,183 units, each unit consisting of (i) one share of common stock and (ii) one warrant to purchase 0.5 of a share of common stock, at a purchase price of $2.70 per unit. The warrants will be exercisable six months after issuance at $3.30 per share and will expire five years from the date of issuance. The shares of common stock and warrants are immediately separable and will be issued separately.

Alexza estimates that net proceeds from the offering will be approximately $16.4 million, after deducting placement agents' commissions and estimated offering expenses. The Company intends to use the net proceeds from the sale of the securities primarily for general corporate purposes, including clinical trial, research and development, general and administrative and manufacturing expenses.

RBC Capital Markets Corporation is acting as the sole lead placement agent and JMP Securities LLC is acting as co-agent in this offering.

The securities described above are being offered pursuant to a registration statement on Form S3 previously declared effective by the Securities and Exchange Commission on May 20, 2010. The transaction is expected to close on or about August 10, 2010, subject to customary closing conditions.

A copy of the prospectus supplement relating to the offering and the accompanying base prospectus may be obtained by contacting RBC Capital Markets at 3 World Financial Center, 8th Floor, 200 Vesey Street, New York, NY 10281, Attention: Equity Syndicate, or by calling (212) 428-6670, or JMP Securities, 600 Montgomery Street, Suite 1100, San Francisco, CA 94111, Attention: Prospectus Department, or by calling (415) 835-8900. A copy of the prospectus supplement relating to the offering and the accompanying base prospectus may also be accessed on the SEC website, http://www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of Alexza nor shall there be any sale of such securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

mazzam 30-08-10 23:53

Rodman&Renshaw sept 12-15 2010
 
http://www.meetmax.com/sched/event_6...?event_id=6089

calopre 31-08-10 00:34

Citazione:

Originalmente inviato da mazzam (Messaggio 26362624)

grazie molto interessante, speriamo che tutto ciò che verrà comunicato venga accompagnato da un buon momento-movimento di borsa.

e che....... sarebbe pure ora di uscire da questo pantano

calopre 01-09-10 09:39

FDA priority review status sends pSivida shares higher PDF | Print | E-mail
Written by BioMedReports.com Staff
Tuesday, 31 August 2010 18:10
0
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Below is a list of the companies that made news in the healthcare sector on Monday, August 31, 2010.


PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today after the market closed announced that it has agreed to sell its Illumination and Detection Solutions (IDS) business to Veritas Capital Fund III, L.P. a New York-based private equity firm, for approximately $500 million in cash ($482 million net of payment for acquired cash balances).

IDS includes approximately 3,000 employees and 14 manufacturing facilities worldwide and is a leading global provider of custom-designed specialty lighting and sensor components, subsystems and integrated solutions to major OEMs serving a number of applications within various health, environmental, and security segments. The business is expected to generate revenue of approximately $300 million in 2010.

Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions, announced today after the bell that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel’s RapidVue® hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG).

"Our customers have expressed a preference for testing flexibility and our new RapidVue hCG product provides healthcare professionals with an additional format for pregnancy testing," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "RapidVue hCG is Quidel’s fourth product launch in the United States this year and is further confirmation of our success at reinvigorating our new product pipeline."

The 3-minute RapidVue hCG test is CLIA-waived for use with urine samples. Due to the assay’s dipstick format, RapidVue hCG requires no specimen manipulation in order to perform the test.

StemCells, Inc. (Nasdaq:STEM) announced today that its technology was recently used by independent researchers to achieve the first genetically engineered rat derived from rat embryonic stem (ES) cells. This breakthrough, published this month in the international peer-reviewed journal Nature, opens the door to the types of genetic manipulations previously only possible in mice, and paves the way for modeling a broader range of human diseases with the rat. Both mice and rats are used as animal models of human disease; however certain aspects of the rat's physiology, behavior, and metabolism are closer to the human, making rats the preferred species for drug development and studying human disease. The creation of this first rat model using rat ES cells validates intellectual property owned by StemCells, which includes the rights to patents covering both rat ES and rat induced pluripotent stem (iPS) cells as well as genetically engineered rats derived from these cells.

Earlier Tuesday:

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences (NASDAQ:ALIM) has been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).

FDA Priority Review status is given to therapies that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This status reduces the review time goal from 10 months to six months.

Dr. Paul Ashton, President and CEO of pSivida said, "With priority review a response from the FDA regarding Iluvien could be received in the fourth quarter of this year. Approval of Iluvien would trigger a $25 million milestone payment to pSivida from Alimera. Under the license agreement pSivida is also to receive 20 percent of net profits on sales by Alimera."

After closing Monday's trading session at $3.26, Tuesday, shares of pSivida shot up as high as $3.75 before pulling back late in the day and closing at $3.43, up more than 5%.

Dynavax Technologies Corporation (NASDAQ:DVAX) announced today a grant from the National Institute of Allergy and Infectious Diseases (NIAID) to take a systems biology approach to study the differences between individuals that do or do not respond to vaccination against the Hepatitis B virus. This study will be one of several projects covered in a five-year, $17.6 million grant to Dr. Jacques Banchereau of the Baylor Institute of Immunology Research in Dallas as part of the Human Immune Phenotyping Centers program.

EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that it will actively pursue its communication, education and marketing strategy by participating in select highly-regarded worldwide urology events.

Earlier this month, EDAP highlighted its technologies at the Asian Congress of Urology. In September, EDAP's sales and marketing team will participate in the 28th World Congress of Endourology and Shock Wave Lithotripsy (WCE & SWL), to be held in Chicago-Hotel Sheraton on September 1-3, 2010. Five abstracts will be presented specifically on the use of Ablatherm-HIFU as primary care and salvage for prostate cancer and the positive results achieved.

Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced the completion of its root cause investigation regarding HYLENEX manufacturing and has identified a corrective action plan and regulatory strategy to reintroduce HYLENEX to the market. Halozyme and Baxter are finalizing the materials for a meeting with the U.S. Food and Drug Administration to seek concurrence with the reintroduction strategy. During several meetings and discussions held between the two companies, Baxter's senior management has reiterated its commitment to the successful commercialization of HYLENEX. As a result of this progress, Halozyme has lifted the notice of breach that was delivered to Baxter Healthcare Corporation on May 16, 2010.

On May 17, 2010, Halozyme announced the voluntary withdrawal of affected lots of 150U HYLENEX product from distribution after Halozyme and Baxter confirmed the presence of particles in a limited number of vials of HYLENEX. This action was taken as a precautionary measure to ensure patient safety. Since then, the voluntary withdrawal has been proceeding as planned. To date, no adverse medical events have been reported in connection with noncompliant HYLENEX product.

Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) announced today it has resumed collaborations with Mayo Collaborative Services, Inc. to conduct a clinical study for the validation of RPC's US FDA-approved Onko-Sure® in vitro diagnostic (IVD) cancer test as a useful tool in colorectal cancer (CRC) recurrence and treatment monitoring.

Also Tuesday:

A5 Laboratories Inc. (A5 Labs) (OTCBB:AFLB) today announced the CRO team headed by Dr. Matni has completed the validation of the first set of equipment that will be used for the testing of pharmaceutical raw materials and finished products.

Affymax, Inc. (Nasdaq:AFFY) today announced the company’s participation in the following investor conferences during the month of September.

Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved LUMIGAN® (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

China-Biotics, Inc. (Nasdaq:CHBT), a leading developer, manufacturer and distributor of probiotics products in China, today announced that the Company will host an Investor Day on Monday, September 20, 2010, in Shanghai. Members of China-Biotics' management team will present the Company's strategic goals, product developments, and key milestones.

D. Medical Industries Ltd. (NASDAQ:DMED) (TASE: DMDC) a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, today announced financial results for the three and six months ended June 30, 2010.

Ferro Corporation (NYSE: FOE), announced today the final results of its tender offer for all of its outstanding 6.50% Convertible Senior Notes due 2013, which expired at midnight, New York City time, on August 30, 2010.

.

Oncothyreon Inc. (Nasdaq:ONTY) today announced the appointment of Julie M. Eastland as Chief Financial Officer and Vice President, Corporate Development, effective September 7, 2010.

Orthofix International N.V. (NASDAQ: OFIX) announced today that it has established a new $300 million five-year credit facility, including a $200 million senior secured revolving line of credit and a $100 million senior secured term loan. JP Morgan Chase Bank, N.A. acted as Sole Bookrunner and Joint Lead Arranger along with RBS Citizens.


Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) announced today that the Company will present preclinical findings for its humanized monoclonal antibodies that bind and neutralize the potentially life-threatening toxins produced by the bacterium, Clostridium difficile.


Sanomedics International Holdings (Pink Sheets: SIMH), today announced that Gary O'Hara has been named Chief Technology Officer for Sanomedics International Holdings.

Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, today announced its support for inflammatory bowel disease (IBD) fellowships at leading medical institutions across the country.

Sirona (NASDAQ: SIRO), the dental technology leader, today announced that John Sweeney, Vice President of Investor Relations, will present at Baird's 2010 Health Care Conference on Tuesday, September 14th at the St. Regis Hotel in New York City.

lovis 01-09-10 13:22

http://www.profeticconsult.com/apps/calendar/


se puo essere utile,,,,:)

non metto la mano sul fuoco per l'attendibilità però 1 sguardo ogni tanto:)

calopre 01-09-10 13:35

sempre utile fare confronti
ok grazie

calopre 01-09-10 15:18

Celldex Therapuetics: Bottom play with upcoming catalysts PDF | Print | E-mail
Written by Patrick Crutcher
Wednesday, 01 September 2010 07:36
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Shares of Celldex Therapuetics Inc.(NASDAQ:CLDX) appears to have hit a stable bottom, having fallen more than 50% from their ASCO 2010 highs. With shares now at substantially cheaper levels, investors may want to consider the investment in CLDX given several upcoming catalysts. They are currently trading just roughly $0.30 cents above all-time lows with a great future ahead of them. At these levels, CLDX represents a unique buying opportunity, as they are poised to be a leading player in the future of immunotherapy.
CLDX has emerged as a bio-pharmaceutical company that is developing a robust pipeline of innovative, applied immunology product candidates focused on the treatment of cancer and infectious disease. CLDX's Precision Targeted Immunotherapy Platform generates product candidates for clinical development that include therapeutic cancer vaccines, monoclonal antibodies, and vaccines which are targeted to specific markers associated with the underlying disease.



CELLDEX THERAPEUTIC
4.33 - (0.00%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.Their main clinical development has been in Rindopepimut (formerly PF-04948568 or CDX-110), which is a peptide-based cancer immunotherapy product candidate targeting the tumor specific molecule called EGFRvIII, which is a functional variant (tumor-specific) of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. While originally discovered in glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer, the expression of EGFRvIII has also been observed in various other cancers such as breast, ovarian, metastatic prostate, colorectal, and head & neck cancers.

CDX-110 has been granted both Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA), as an investigational immunotherapy for the treatment of EGFRvIII expressing Glioblastoma Multiforme(GBM). In April 2008, Celldex entered into an agreement with Pfizer Inc.(PFE), which granted PFE an exclusive worldwide license to CDX-110. Pfizer Vaccines has exclusive rights to the use of EGFRvIII vaccines in other potential indications. Pfizer made an upfront payment of $40M and a $10M equity investment in CLDX. Pfizer will fund all development costs for these programs. CLDX is also eligible to receive milestone payments exceeding $390 million for the successful development and commercialization of CDX-110 and additional EGFRvIII vaccine products, as well as double-digit royalties on any product sales.

So far, CDX-110 has lived up to the technology’s potential. At ASCO 2010, they reported interim results on their ACT III study. 70 percent of ACT III patients were progression-free at 5.5 months after initiating treatment with CDX-110, which corresponds to the 8.5 months seen in ACT II and ACTIVATE when measured from diagnosis and surgery. This is significant, since historic controls from Duke/MDACC studies had median progression free survival for patients with EGFRvIII positive GBM was 6.3 months. In the ACTIVATE phase IIa study, CDX-110 treated GBM patients showed a median survival time of 30 months, more than a 100 percent increase in survival, vs historical control's median of 14.5 months. The study demonstrated a median time-to-progression of 13 months (p=0.0001) vs. historical control's median of 6.4 months.

Investors can find results from their Phase 2 study ACTIVATE and ACT II and their clinical trial page for ACT III.

There are some upcoming catalysts (before year’s end) investors should be looking forward to:

Phase 3 initiation of CDX-110: The future of CDX-110 is out of CLDX’s hands now, as Pfizer Inc.(PFE) will be in charge of the Phase 3 trials. PFE is currently working with the FDA and several international regulatory agencies to set up a pivotal(Phase 3) trial that will use a commercially feasible EGFRvIII diagnostic kit to identify vIII positive patients. The recent failures in the cancer arena at PFE could be even more incentive for CLDX, as a renewed interest in their technology could fuel further development to replace failures at Pfizer. The initiation of this trial, CLDX should be set to receive an undisclosed milestone payment. Some believe it could be within the range of $40-50 million, adding significant value to CLDX. Additionally, Phase 2 overall survival data from the ACTII trial will be published when the median is reached, which is extremely encouraging given the trial length to-date.

Phase 2b trial initiation in 3Q2010 of CDX-011: CDX-011 is an antibody-drug conjugate (ADC) in Phase 2 development for the treatment of melanoma and advanced breast cancer. CDX-011 is a fully-human monoclonal antibody-drug conjugate that targets glycoprotein NMB (GPNMB). CLDX has developed a commercial diagnostic assay to diagnose GPNMB positive patients. At ASCO 2010, results for the Phase 1/2 trial in advanced breast cancer and Phase 2 in melanoma were presented. The results from the breast cancer trial are very encouraging and the planned pivotal trial could prove it to be effective treatment for GPNMB postive patients. The objective response rate of 25% in end-stage breast cancer compares favorably with the 12% ORR shown by the approved drug ixabepilone.The estimated market is $400M for advanced breast cancer. Additionally, CLDX’s Chief Medical Officer, Dr. Tom Davis, will be presenting about the “Clinical Development of CDX-011, an ADC Targeting GPNMB” at World ADC Summit, an antibody-drug conjugate meeting.

For brevity, CLDX also has 2 other candidates worth noting, specifically CDX-1307 and CDX-1401. CDX-1307, their lead APC Targeting Technology™ product candidate, is in development for the treatment of cancers that express the beta chain of human chorionic gonadotropin ( hCG-β). hCG-β is an established tumor-associated antigen that is over-expressed in a variety of common cancers including those of the colon, lung, pancreas, esophagus, breast, bladder, cervix, stomach, and prostate, but not expressed in most normal tissues. A Phase 2 trial of CDX-1307 in the treatment of newly diagnosed bladder cancer is underway, full enrollment is expected by 4Q2011.

CDX-1401, is in Phase 1/2 development for the treatment of cancers known to express NY-ESO-1, including cancers of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma and melanoma. CLDX intends to update investors on CDX-1401 Phase 1/2 trial for several solid tumors in 4Q2010.

CLDX has roughly $68M in cash and cash equivalents, which should take them well through 2011 and into 2012. Milestone payments relating to initiation of Phase 3 in CDX-110 should certainly help bolster their reserves. They have roughly 32M outstanding shares and strong institutional backing. As of 8/13/2010, there are roughly 4M shares short yet analysts are very bullish on CLDX.

Investors are encouraged to read their 2nd quarter report and see their June 2010 presentation. Going forward, I believe CLDX is currently undervalued and believe they have a bullish outlook for the rest of 2010.

calopre 01-09-10 16:33

Obama administration appeals stem cell injunction PDF | Print | E-mail
Written by Jeremy Pelofsky for Reuters
Wednesday, 01 September 2010 09:17
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The Obama administration asked a federal judge on Tuesday to lift an injunction halting human embryonic stem cell research, saying it would irreparably harm research and cost more than 1,300 jobs.

The Justice Department also appealed against the injunction by Judge Royce Lamberth in which he ruled National Institutes of Health funding of human embryonic stem cell research violated a law called the Dickey-Wicker Amendment, which bars federal funding of work that involves destroying embryos.

The administration said Lamberth's ruling was overly broad and was having a significant negative impact on embryonic stem cell research, arguing that there was "serious doubt" Congress intended the legislation to be so encompassing.

"Numerous ongoing projects will likely not survive even a temporary gap in funds, jeopardizing both the potential benefit of the research and the hundreds of millions of dollars of taxpayer funds already invested in it," the filing said.

The Justice Department asked Lamberth to rule by September 7 on the request to lift his injunction.

Lamberth's injunction was a setback for President Barack Obama and the issue could become a theme in November elections where his fellow Democrats who control both chambers of Congress are facing tough races.

One of Obama's first acts after taking office in 2009 was to broaden federal funding of human embryonic stem cell research -- a controversial decision because some people oppose any destruction of human embryos, even for medical research.

Dr. James Sherley, a biological engineer at Boston Biomedical Research Institute, and Theresa Deisher of Washington-based AVM Biotechnology sued, saying Obama's policy violated Dickey-Wicker and harmed their own chances of getting funding for similar research not involving embryos.

Sherley and Deisher's "remote economic self-interests do not outweigh the harm the injunction will cause NIH, the hundreds of affected human embryonic stem cell researchers, and the millions of individuals who hold out hope that human embryonic stem cell research will lead to the cure for, or treatment of, their currently incurable illnesses," the Justice Department said.

The administration pointed to 24 projects up for renewed federal funding between now and the end of September and said the benefits from the research could be lost. If the projects ended, it would waste $64 million already invested, the administration said.

Overall, the injunction could put 1,300 jobs at risk, NIH Director Francis Collins said in a declaration to the court.

Earlier on Tuesday, Democratic Representative Diana DeGette said she would push to revive legislation specifically allowing federal funding of the research by the end of September.

"We need to pass legislation in September to fix this problem," she told Reuters in a telephone interview.

DeGette co-sponsored bipartisan legislation that passed both the House and Senate twice and was twice vetoed by then-President George W. Bush.

DeGette said she believed there was support in the House and Senate, as well as in both parties, to push through legislation quickly.

calopre 01-09-10 20:46

ho deciso
da oggi solo alexza e vivus
spero di non ricascarci con le fantaciofeche

alex1664 01-09-10 23:00

Citazione:

Originalmente inviato da alex1664 (Messaggio 26343375)
calopre mi hanno segnalato questa:

La conosci?

Ivax diagnostics

Citazione:

Originalmente inviato da calopre (Messaggio 26343505)
tratta reagenti e poco altro, circa 200 prodotti, voglia di espansione con conseguenti costi.
Poco trattata 15 milioni di capitalizzazione circa
non so, se magari ci fai sapere a che pro ti è stata segnalata.
Exas
alxa
arna
credo siano più interessanti

Citazione:

Originalmente inviato da alex1664 (Messaggio 26347376)
ivax diagnostics (amex: Ivd)

market cap: 15.24m
price: 0,55 $

shares outstanding: 27.65m --(18 m shares held by insiders)
float: 7.50m


dr. Struby continued, “our efforts with respect to our 510(k) premarket submission filing with the u.s. Food and drug administration for the mago® 4s, our next-generation fully automated elisa system for autoimmune and infectious disease testing, are progressing, and we continue to expect to receive regulatory approval from the fda and launch the product during the fourth quarter of 2010. Following the receipt of all required regulatory approvals and the subsequent commercial launch of the product, we expect the mago® 4s will provide a flexible, efficient and cost-effective solution to high-performance laboratories, and will be our primary platform for marketing our kits in the u.s.”

0.670
+0.121 (21.93%):d:d

calopre 02-09-10 09:53

Cardiome Pharma shares up on EU approval. Inhibitex reports positive Phase1a results. IVAX sells majority interest PDF | Print | E-mail
Written by BioMedReports.com Staff
Wednesday, 01 September 2010 17:58
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Below is a list of the companies that made news in the healthcare sector on Wednesday, September 01, 2010.



Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) and Merck (NYSE:MRK) today announced that the intravenous (IV) formulation of BRINAVESS (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults: for non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less.

BRINAVESS acts preferentially in the atria and is the first product in a new class of pharmacologic agents for cardioversion of AF to launch in the EU.

"This medicine offers physicians, patients and hospitals an important new therapy option to use for the rapid treatment of recent-onset AF, and we are pleased to add this to our strong portfolio of medicines for cardiovascular disease," said Patrick Magri, senior vice president, general manager, Cardiovascular Franchise, Merck. "We welcome this important milestone in our collaboration with Cardiome and we look forward to launching BRINAVESS in the EU beginning in the fourth quarter of 2010."

"European approval of BRINAVESS and Merck’s subsequent launch represent an exciting juncture in Cardiome’s evolution which will provide us with our first commercial product revenues," said Doug Janzen, president and chief executive officer of Cardiome. "This success was made possible through the commitment and hard work of our employees and our partner Merck, the support of our shareholders, and the efforts of many dedicated medical professionals and patients who have taken part in the clinical program."

On heavy volume, shares of Cardiome were trading higher by more than 13% or 81 cents after the bell.

Inhibitex, Inc. (Nasdaq: INHX), announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial are as follows: *INX-189 was generally well tolerated at all dose levels; *No drug-related serious adverse events; *No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion; *No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and *Pharmacokinetic data supports INX-189’s potential for once daily (QD) dosing.

"We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial," stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. "Based upon the pharmacokinetics observed in this study, we continue to believe that INX-189 has the potential to demonstrate antiviral activity with a low once-daily dose, and we look forward to assessing its ability to reduce HCV RNA viral loads in patients with chronic hepatitis C in a Phase 1b multiple ascending dose trial we plan to start in the fourth quarter."

Shares rose 14.79% or 21 cents to $1.63.

IVAX Diagnostics, Inc. (NYSE Amex: IVD), a fully integrated in vitro diagnostics company, announced that today ERBA Diagnostics Mannheim GmbH purchased from a group controlled by Patrice Debregeas and Paul Kennedy all of the approximately 72% of the outstanding shares of IVAX Diagnostics owned by their group for $0.75 per share, or an aggregate purchase price of approximately $15 million. ERBA Diagnostics Mannheim, headquartered in Mannheim, Germany, is an emerging player in the in vitro diagnostics market.

Shares of IVAX shot up 11 cents or more than 20% to 66 cents on the news.

Also Wednesday:

Abbott (NYSE:ABT) announced today it has received approval from the U.S. Food and Drug Administration to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient's blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results.

Allergan, Inc. (NYSE: AGN) today announced that it has reached a resolution with the United States Department of Justice (DOJ) regarding the previously reported Government investigation into Allergan's past U.S. sales and marketing practices relating to certain therapeutic uses of BOTOX® (onabotulinumtoxinA).

BSD Medical Corporation (NASDAQ: BSDM) today reported that the Company has received certification that the MicroThermX Microwave Ablation System (MTX-180) meets all requirements for safety and performance needed for compliance with the IEC 60601-1, safety standard, "Medical Electrical Equipment Part 1: General Requirements for Safety." IEC 60601-1 is the global benchmark for safety of medical equipment and is a crucial tool for demonstrating compliance with regulatory requirements around the world, including the requirements for CE Marking and FDA clearance. Receipt of this certification will allow BSD to add the TUV safety mark to the MTX-180 system. Nearly all hospitals and clinics in the U.S. require a safety mark on equipment prior to purchase.

Shares of BSD Medical jumped as high as $2.49 before pulling back and closing at $2.30, up 10 cents or 4.55%.

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), for advanced development of the company’s third generation anthrax vaccine candidate. The award of this contract increases to over $58 million the total potential development funding from NIAID for this product. This product candidate, one of two third generation vaccines being developed as part of Emergent’s anthrax franchise, consists of BioThrax (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909 (VaxImmune).

"Emergent applauds the U.S. government’s commitment to protecting the nation against biological threats by supporting critical development of advanced vaccine and therapeutic candidates," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions.

Genzyme Corp.(NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that data from the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) were presented today at the European Society of Cardiology’s Congress 2010 in Stockholm, Sweden. The study met its primary endpoint with a 28 percent reduction in LDL-cholesterol, compared with an increase of 5 percent for placebo. The trial also met all of its secondary and tertiary endpoints. Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in other mipomersen studies.

iBio, Inc. (OTCBB: IBPM), its development collaborator, Fraunhofer USA Center for Molecular Biotechnology (CMB), and GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced their entry into an agreement to jointly develop and globally market manufacturing solutions for biopharmaceuticals and vaccines based upon their respective proprietary technologies. Financial terms are not being disclosed.

Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage trials to treat and prevent Alzheimer's disease (AD), has announced that Daniel G. Chain, Ph.D., the company's chief executive officer and chairman of the board, will speak at the Rodman & Renshaw Annual Global Investment Conference in New York City on September 14, 2010.

Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that it has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. (Diosynth) for the manufacture of Drug Substance integral to the production of NicVAX, Nabi's innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.

PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) today announced revenue guidance for the third quarter ended September 30, 2010 of approximately $86 million, as compared with actual results of $71.4 million for the third quarter of 2009, a 20 percent year-over-year increase. The growth is primarily driven by increased second quarter 2010 sales of Avastin®, Herceptin®, Lucentis® and Tysabri® for which PDL receives royalties in the third quarter of 2010. Also included in third quarter 2010 guidance is $2.9 million earned on Eurodollar foreign currency hedging contracts that the Company initiated in January 2010. The royalty payment from Genentech included royalties generated on both U.S. and ex-U.S. manufactured products and sales.

Pfizer Inc. (NYSE:PFE) and FoldRx Pharmaceuticals, Inc., a privately held drug discovery and clinical development company, today announced that they have entered into an agreement under which Pfizer will acquire FoldRx. FoldRx's portfolio includes clinical and pre-clinical programs for investigational compounds to treat diseases caused by protein misfolding, which is increasingly recognized as an underlying cause in many chronic degenerative diseases. The company's lead product candidate, tafamidis meglumine, is in registration as an oral, disease-modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option that is currently available. While specific financial terms were not disclosed, Pfizer will make an upfront payment and contingent payments if certain milestones are achieved.

Also Wednesday:

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex:ANX) today announced that the Company's Chief Executive Officer, Brian M. Culley, will present at the Rodman & Renshaw Annual Global Investment Conference on Tuesday September 14, 2010 at 11:40 a.m. Eastern time, in the Hubbard Salon at the New York Palace Hotel in New York.

AmStem Corporation (OTCBB: AMST), a leading provider of biotherapeutic and cosmetic stem cell products, stem cell collection and storage expertise and access to nanotechnology vital to stem cell research, announced today the appointment of Dwight Brunoehler as president of the company.

Gilead Sciences, Inc. (Nasdaq:GILD) today provided an update on the company's previously announced $5.0 billion stock repurchase program authorized by Gilead's Board of Directors in May 2010. Gilead has repurchased approximately $2.2 billion in common stock under this program through August 31, 2010.

Given Imaging (NASDAQ: GIVN) today announced that Mr. Homi Shamir, President and Chief Executive Officer, will present at the following investor conferences: The Morgan Stanley Global Healthcare Unplugged Conferencein New York City on Tuesday, September 14, 2010 at 1:00 pm ET.

mazzam 02-09-10 18:00

The Biotechnology Industry Organization October 5-6
 
http://www.pr-inside.com/bio-announc...d-r2073677.htm

calopre 02-09-10 20:20

preso qualcosa di myrx ,mi piace quasi a pari di exas
alleggerito vivus e alxa

calopre 03-09-10 10:09

Orexigen soars on license deal. Rexahn up on research article. BioDelivery reports positive FDA meeting PDF | Print | E-mail
Written by BioMedReports.com Staff
Thursday, 02 September 2010 17:47
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Below is a list of the companies that made news in the healthcare sector on Thursday, September 02, 2010.


Orexigen® Therapeutics, Inc. (Nasdaq:OREX) and Takeda Pharmaceutical Company Limited (TSE:4502.to), today announced that they have entered into an exclusive partnership to develop and commercialize Contrave® (naltrexone SR/bupropion SR), Orexigen's investigational drug for the treatment of obesity, in the United States, Canada and Mexico.

Contrave is a combination therapy believed to address both biological and behavioral drivers of obesity. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave on March 31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

Under the terms of the agreement, Orexigen will receive an upfront cash payment of $50 million from Takeda, and Takeda will obtain an exclusive marketing right from Orexigen in the United States, Mexico and Canada while Orexigen retains the right to co-promote with Takeda in the United States. Orexigen will be eligible to receive payments of over $1 billion upon achieving certain regulatory and sales-based milestones. Assuming Contrave is commercialized, Takeda will pay tiered double-digit royalty payments on net sales in the Territory.

Shares of Orexigen soared more than 18% on the news, closing Thursday trading at $5.43, up 84 cents.

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the publication of a research article in Bioorganic & Medicinal Chemistry Letters on the anti-tumor activity of RX-8243 and its analogues.

The article offers data demonstrating that RX-8243, an isoquinolineamine analogue, significantly inhibits the growth of human cancer cells, including paclitaxel (Taxol) resistant HCT-15 human colorectal cancer cells and the growth of tumor in in vivo model of nude mice injected with paclitaxel-resistant HCT-15 human colorectal cancer cells.

"We are encouraged by the results of this study of RX-8243, which shows the potent anti-tumor properties of this unique compound," said Chang Ahn, Chief Executive Officer of Rexahn. "The study clearly demonstrates that RX-8243 inhibited tumor formation in paclitaxel-resistant cancer model, suggesting that isoquinolineamine and its analogues have the potential to become a novel class of anti-tumor chemotherapeutics."

On heavy volume shares of Rexahn jumped nearly 5%.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) today announced a positive meeting with the U.S. Food and Drug Administration, Meda and BDSI that occurred on Wednesday, July 21, 2010 to discuss significant modifications to the existing Risk Evaluation and Mitigation Strategy (REMS) program for ONSOLIS (fentanyl buccal soluble film).

At the meeting, FDA and Meda discussed REMS modifications that seek to reduce unintended barriers to prescribing and expand access to ONSOLIS for appropriate patients.

BDSI believes that the recently submitted proposed REMS modifications, which are under FDA review, should facilitate the ability of healthcare providers to prescribe ONSOLIS for appropriate patients as well as improve patient access through broadened distribution.

Shares of BioDelivery initially shot up to $2.73 on the news and finished the day at $2.45, up 12 cents or 5%.

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc. The milestone was triggered by Agensys’ initiation of a phase I trial for AGS-16M8F, an ADC for the treatment of cancer utilizing Seattle Genetics’ technology.

"This trial initiation increases the total number of ADC programs utilizing our technology currently in clinical trials to eight, further extending the investigation of our technology for the treatment of multiple types of cancer," said Eric L. Dobmeier, Chief Business Officer of Seattle Genetics. "Our ADC collaborations generate substantial financial resources for Seattle Genetics, including more than $130 million received to date. We also have the potential to receive approximately $2.7 billion in milestone payments if all collaborator ADCs are commercialized, as well as royalties on net sales of resulting ADC products."

NewCardio (OTC Bulletin Board:NWCI.ob) today announced that Vincent Renz, Jr., NewCardio's President and CEO, purchased 128,000 shares during his trading window in open market transactions in the two weeks following the Company's filing of its SEC Form 10-Q and earnings conference for the second quarter ended June 30, 2010.

"As discussed on our August 12, 2010 investor conference call, we are focused on the underlying fundamentals that will enable us to create long term value for our employees, customers and shareholders," commented Mr. Renz. "We continue to make steady progress with the commercialization of QTinno as our efforts to enhance market awareness and adoption through our interactions with clinical trial service providers, sponsors and regulatory authorities are starting to translate into increasing sales opportunities which we believe will drive revenue growth and expansion. In addition, we are working to identify opportunities, either through strategic partnerships or other relationships, to source additional capital that will enable us to accelerate the development and commercialization of our proven 3-D platform technology in delivering additional solutions which will advance the ECG as a diagnostic tool."

Mr. Renz continued, "Specifically, the additional capital will be focused on the commercialization of our second and third products, CardioBip™ and Cardio3KG. Based on the progress we have made in the development and validation efforts to date, as well as the size of the potential markets that these solutions will address, I do not believe the market has appropriately valued NewCardio, for either our achievements to date or the potential of our underlying 3-D technology platform. My recent purchases demonstrate my confidence in our ability to create long term value and reinforce my long-term commitment to helping the Company maximize its chances for success."

Celsion Corporation (Nasdaq:CLSN), a biotechnology drug development company, announced today that it has been awarded a competitive Phase I Small Business Innovation and Research (SBIR) grant from the National Institutes of Health (NIH), to support the proposal, "New Thermal Sensitive Carboplatin Liposomes for Cancer". This funding will support the Company's efforts to develop its proprietary heat-activated liposomal technology in combination with carboplatin, an approved and frequently used oncology drug for treatment of a wide range of cancers. The grant is valued at approximately $200,000 and will support formulation development and preclinical efficacy studies in collaboration with Duke University.

Health Discovery Corporation (OTCBB: HDVY) is pleased to announce that Herbert A. Fritsche, Ph.D., recently retired Professor of Laboratory Medicine and Chief of the Clinical Chemistry Section at The University of Texas, M.D. Anderson Cancer Center in Houston, Texas, has joined Health Discovery Corporation as Senior Vice President and Chief Science Officer, effective September 1, 2010.

Also Thursday:

AdCare Health Systems, Inc. (NYSE Amex:ADK), a recognized innovator in senior living and health care facility management, has closed the lease of three nursing homes according to the previously announced agreement to lease five additional nursing homes in Georgia.

Aspen Technology, Inc. (NASDAQ: AZPN), a leading provider of software and services to the process industries, today announced financial results for its fourth quarter and fiscal year 2010, ended June 30, 2010.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that the company's management will present at several upcoming investment conferences.

Bohai Pharmaceuticals Group, Inc. (OTCBB/OTCQB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, today announced that the Company will present at the Rodman & Renshaw Annual Global Investment Conference at The Palace Hotel in New York City on Wednesday, September 15, 2010 at 11:40 am Eastern time.

Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today that the U.S. National Institutes of Health (NIH), National Center for Complementary and Alternative Medicine (NCCAM) Small Business Technology Transfer Program, has approved and funded a grant to be shared by Bionovo and Dr. Dale Leitman from the University of California at Berkeley (UCB).

Cerus Corporation (NASDAQ:CERS) announced today the successful outcome of a multi-year trial of INTERCEPT-treated platelet components conducted at the Swiss Red ross Blood Center in Basel, Switzerland.

Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced that the Board of Directors has voted to declare a dividend of $0.25 per share.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces that all five products in its novel line of XTRASORB® HCS Dressings have received Healthcare Common Procedural Coding System (HCPCS) codes.

Emerging Healthcare Solutions Inc. (PinkSheets:EHSI) announced today that Stand-By Systems (SBS) delivered a virtual demonstration of its products at a Homeland Security Procurement Fair this month.

Genome Research Group (GRG) (PINKSHEETS: KKUR) recently announced its intended merger with ChromoCure, Inc. and consolidation of the operations and technologies of both groups.Genome Research Group personnel have assumed all executive and board duties and have no current or planned operations in the USA.

Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog®, and insulin lispro, the active ingredient in Humalog®. Diabetes patients enrolled in these cross-over design studies will receive an insulin analog alone and the Analog-PH20 treatment for 12 weeks each.

HealthMed Services Ltd. (OTCBB: HEME), an innovative software development company, is pleased to announce that it has entered final negotiations to acquire all rights, title and interest to Neural Communicator software and hardware.

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops antibody-based targeted anticancer products, today announced that Company management will present at multiple investor conferences this month.

IntelGenx Corp. (OTCBB:IGXT) today announced the completion of a pilot study that indicates that IntelGenx has successfully developed a novel oralfilm, INT007, that is bioequivalent to a leading branded tablet containing a phosphodiesterase type 5 (PDE-5) inhibitor for the treatment of erectile dysfunction.

K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has received notification from the New York Stock Exchange ("NYSE") stating that the Company has reestablished compliance with the NYSE's minimum share price requirements for continued listing on an accelerated basis.

LifeVantage Corporation (OTC Bulletin Board:LFVN), the maker of Protandim®, a clinically proven, science-based therapy for oxidative stress, announced today that a new peer-reviewed study involving Protandim® was published in the scientific journal PLoS ONE.

Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Tarek Sherif, chairman and chief executive officer, and Bruce Dalziel, chief financial officer, will present at the Deutsche Bank Technology Conference at 11:05 a.m. ET (8:05 a.m. PT) on September 15, 2010 in San Francisco, CA.

MedLink (OTCBB: MLKNA), a lea ing provider of Electronic Health Records and practice management solutions, today announced a partnership with Thrasys, Inc. a provider of next-generation health information technology and solutions.MedLink and Thrasys have collaborated to provide interoperability and health record management based on SyntraNet from Thrasys, a cloud based Health Information Exchange (HIE) and Collaboration Network.

Metiscan, Inc. (PINKSHEETS: MTIZ) announced today shareholder points of interest discussed during the Company's nationwide teleconference yesterday.

Omnicare, Inc. (NYSE:OCR), a leading provider of pharmaceutical care for the elderly, announced today that it will participate in the Stifel Nicolaus 2010 Healthcare Conference on September 15 at 2:05 p.m. EDT in Boston, Massachusetts.

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) announced the Gynecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN(R) in patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer (GOG186H).

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that it will report financial results for the first quarter fiscal year 2011 on September 9, 2010 after market and will host a conference call and webcast at 4:30 p.m. EDT (1:30 p.m. PDT).

PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today announced the extension of their OneSource Laboratory Services contract with Minerva Scientific, a specialist pharmaceutical testing laboratory based in Derbyshire, UK.

Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that Professor Ashley Bush, a co-founding scientist of Prana and a member of the Company's R&D Advisory Board, has in conjunction with the University of Melbourne, Australia, and Harvard Medical School, Boston, published an article that appears online today entitled: "Iron-export ferroxidase activity of beta-amyloid precursor protein is inhibited by zinc in Alzheimer's Disease" scheduled for the September 17 edition of Cell, the prestigious peer-reviewed, international biological research journal.

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) today announced that R. Don Elsey has been appointed to the Company's board of directors, effective September 1.

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, today announced that the Compny will release financial results for the three and six months ended June 30, 2010, after the market closes on Tuesday, September 7, 2010.

calopre 04-09-10 10:33

le notizie del giorno
RxNews Recap for Friday 09.03.10 PDF | Print | E-mail
Written by BioMedReports.com Staff
Friday, 03 September 2010 17:42
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Below is a list of the companies that made news in the healthcare sector on Friday, September 03, 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.


American Physicians Service Group, Inc. (NASDAQ:AMPH) today announced that its Board of Directors had authorized the early redemption of all of APS' 3% Series A redeemable preferred stock, valued at approximately $6 million, and payment of accrued dividends on the preferred stock through the redemption date.

Bruker Corporation (NASDAQ: BRKR), a leading global provider of high-performance scientific instruments, and Bruker Energy & Supercon Technologies, Inc. ("BEST"), a leading provider of superconducting technology and enabling tools and a Bruker subsidiary, today announced that BEST has filed a Form S-1 Registration Statement with the United States Securities and Exchange Commission relating to the proposed initial public offering of common stock of BEST.

Celgene Corporation (NASDAQ: CELG) today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA).

China-Biotics, Inc. (Nasdaq:CHBT), the leading developer, manufacturer and distributor of probiotics products in China, today announced the schedule for the Investor Day, which will be held on Monday, September 20, 2010, in Shanghai.

China Cord Blood Corporation (NYSE:CO) today announced its plan to release financial results for the first quarter of fiscal year 2011 on Friday, September 10, 2010, before the market opens in the US.

CorMedix Inc. (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention anntreatment of cardiorenal disease, today announced it is scheduled to present at the Rodman & Renshaw Annual Global Investment Conference on September 15, 2010, at 11:40 AM ET, in the Fahnestock Salon, 5th Floor, at the New York Palace Hotel in New York.

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the company will be presenting at the Rodman & Renshaw 12th Annual Healthcare Conference at 10:50 a.m. EDT on September 13, 2010, in New York City.

The Female Health Company (Nasdaq:FHCO), which manufactures and markets the FC2 Female Condom®, today announced that the Company's CEO, O.B. Parrish, and its CFO, Donna Felch, are scheduled to make a presentation at Rodman & Renshaw's Global Investment Conference at 12:05 p.m. on Wednesday, September 15, 2010, in the Hubbard Salon, 5th floor.

GeckoSystems Intl. Corp. (PINKSHEETS:GCKO) revealed today further analyses depicting the level of naked shorting of GCKO stock. GeckoSystems is a dynamic leader in the emerging mobile robotics industry revolutionizing their development and usage with "Mobile Robot Solutions for Safety, Security and Service™."

Life Technologies Corporation (NASDAQ:LIFE) today announced it will present at the UBS Global Life Sciences Conference on Wednesday, September 22 at 8:30 a.m.

Omnicare, Inc. (NYSE: OCR) and Walgreen Co. (NYSE: WAG) (NASDAQ: WAG) today announced a transaction in which Omnicare will acquire substantially all of the assets of Walgreens long-term care pharmacy business.

Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) will webcast its presentation at the Morgan Stanley Global Healthcare Conference on Monday, September 13, 2010.

Simulated Environment Concepts, Inc. (PINKSHEETS: SMEV), makers of the high pressurized dry water massage and wellness equipment, SpaCapsule, announced today that hot on the heels of the twelve capsule deal with UK-based Aspire Consulting, the SpaCapsule has once again made a splash in international press, courtesy of Ireland's Life and Fitness Magazine.

UnitedHealth Group (NYSE: UNH) and its family of companies, including UnitedHealthcare, Ovations, AmeriChoice, OptumHealth, Ingenix and Prescription Solutions, is taking immediate action to assist people in North Carolina, Virginia, Maryland, Rhode Island, Massachusetts and Maine, who may be affected by Hurricane Earl.

Walgreens (NYSE: WAG) (NASDAQ: WAG) had August sales of $5.66 billion, an increase of 8.6 percent from $5.22 billion for the same month in 2009. Duane Reade stores, acquired in April 2010, contributed 2.8 percentage points to the total sales increase for the month.

Waters Corporation (NYSE:WAT) and the University of California at Los Angeles (UCLA) will bring together some of the world's leading life science researchers and practitioners of mass spectrometry (MS) at a conference next month to discuss the ways they are applying time-of-flight mass spectrometry to complex biomolecule research and analysis.

calopre 04-09-10 10:43

"Exact Sciences, a company based in Madison, Wis., is developing a colon cancer test based on highly methylated DNA. Its researchers reported last month that by testing for methylated DNA at four markers, pieces of DNA drawn from specific genes, they could detect colon tumors and polyps, distinguishing them from normal tissue with 100 percent sensitivity and with no false positives.
The tests of methylated DNA were performed directly on tumors and are expected to be less accurate in the real world, in which they would have to work in stool samples. Almost all of the DNA in stool is from bacteria, and the methylated DNA is a fraction of the 0.01 percent that is human DNA.
Still, Kevin T. Conroy, chief executive of Exact Sciences, said he expected that the four-marker test, when applied to stool samples, would detect at least half of all precancerous polyps and 85 percent of actual cancers. Results of a trial now under way in 1,600 patients will be reported in October, he said.

The test would cost less than $300, and samples could be collected at home. Patients "
Top

mazzam 06-09-10 22:06

2 Allegato/i
settimanale chiusura
Allegato 1301305

giornaliero candele
Allegato 1301306

http://www.stockta.com/cgi-bin/analy...nd=&mode=stock

calopre 08-09-10 07:46

Idenix falls on FDA clinical hold. After the bell: ZymoGenetics acquired, shares soar PDF | Print | E-mail
Written by Mary Davila
Tuesday, 07 September 2010 18:33
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Below is a list of the companies that made news in the healthcare sector on Tuesday, September 07, 2010.


After the bell Tuesday, Bristol-Myers Squibb Company (NYSE:BMY) and ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash. The transaction, with an aggregate purchase price of approximately $885 million, or approximately $735 million net of cash acquired, has been unanimously approved by the boards of directors of both companies. The board of directors of ZymoGenetics intends to recommend that ZymoGenetics’ shareholders tender their shares in the tender offer. In addition, shareholders holding approximately 37% of the outstanding shares of ZymoGenetics’ common stock have entered into agreements with Bristol-Myers Squibb to support the transaction and to tender their shares in the offer.

"The acquisition of ZymoGenetics brings us full ownership of a promising investigational biologic that strengthens our very diversified Hepatitis C portfolio. Building on our leadership in virology, we are developing a strong portfolio to help patients with Hepatitis C," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. "In addition, ZymoGenetics brings proven capabilities with therapeutic proteins and revenue from a marketed specialty surgical biologic. This acquisition is another example of our strategic, targeted approach to business development."

"By joining forces with Bristol-Myers Squibb, we believe we will enhance the long-term potential of ZymoGenetics’ portfolio of assets, while providing a compelling valuation for our shareholders," said Douglas E. Williams, Ph.D., chief executive officer of ZymoGenetics. "Our collaboration with Bristol-Myers Squibb in the development of PEG-Interferon lambda has been extremely positive and it has given us an opportunity to fully appreciate their capabilities. We believe that this transaction will maximize the potential for our products and product candidates to make a meaningful difference for patients in need."

Shares of ZymoGenetics soared $4.50, more than 84% in extended trading.

Forest Laboratories, Inc. (NYSE: FRX) announced after the market close that the U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee voted 21 – 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 – 0 in favor of approval for complicated skin and skin structure infections (cSSSI).

Ceftaroline is a novel, bactericidal, broad-spectrum injectable cephalosporin shown in pre-clinical and clinical trials to have activity against both gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pneumoniae, and common gram-negative pathogens.

The committee’s recommendation will be considered by the FDA as it reviews the new drug application (NDA) for ceftaroline, which was based primarily on data from two Phase III trials in CABP – FOCUS I and FOCUS II – and two Phase 3 trials in cSSSI – CANVAS I and CANVAS II. Forest anticipates action by the FDA during the fourth calendar quarter.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) moved higher after the bell as the company announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone. REALIZE enrolled three groups of patients with genotype 1 hepatitis C who had undergone at least one prior treatment course with pegylated-interferon and ribavirin but did not achieve SVR: (1) those who relapsed, (2) those who achieved a partial response and (3) those who had almost no response, known as a null response. REALIZE is the only Phase 3 hepatitis C study to date of an investigational direct-acting antiviral therapy that was designed to evaluate all major subgroups of people whose prior treatment was unsuccessful, including those who had a null response. The safety and tolerability results were consistent with results from the other two Phase 3 studies of telaprevir. The REALIZE study was conducted by Vertex’s collaborator, Tibotec.

Watson Pharmaceuticals, Inc. (NYSE:WPI), after the bell today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zarah (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg, the generic equivalent to Bayer's Yasmin®. Watson has begun shipping the product. Bayer's lawsuit against Watson alleging that Watson's product infringes Bayer's U.S. Patent No. 5,569,652 remains pending in the U.S. District Court for the Southern District of New York.

Yasmin® and its generic equivalents had total U.S. sales of approximately $97 million for the twelve months ending June 30, 2010, according to IMS Health. Watson's Zarah™ tablets are indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

In news from earlier in the day:

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold. A clinical hold is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. This decision was made after Idenix notified the FDA of three serious adverse events that occurred during a drug-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers. These observed serious adverse events were elevated liver function tests detected in three subjects during post exposure safety visits. The liver function tests have returned to nearly normal levels in all three subjects during follow-up. All planned studies of IDX184 and IDX320 to date have been completed and there are currently no healthy volunteers or patients receiving IDX184 or IDX320. Idenix will submit full data to the FDA from recently completed preclinical and clinical studies, including 3-month chronic toxicology studies of IDX184, a 14-day study of IDX184 in combination with pegylated interferon/ribavirin (PegIFN/RBV), a 3-day proof-of-concept study of IDX320 in hepatitis C (HCV) infected patients, and the IDX184 and IDX320 drug-drug interaction study in healthy volunteers in order to assess next steps in the development of both compounds.

"We have not yet received a formal letter from the FDA, nor has the Agency had an opportunity to review the safety and efficacy data from recently completed clinical trials with IDX184 and IDX320. Based upon our discussions with the Agency, we are primarily focused on three cases of elevated liver function tests observed during our drug-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers," said Jean-Pierre Sommadossi, Ph.D., Idenix Chairman and Chief Executive Officer. "Based upon the safety and antiviral activity we observed in the IDX184 14-day study and the IDX320 3-day proof-of-concept study, both in HCV-infected patients, we remain committed to the future potential of these drug candidates. We will work closely with independent experts and our external safety committee to better understand the cause of these serious adverse events in the combination study of IDX184 and IDX320 and to provide the FDA with more information in order to expedite their review and resolve this matter as quickly as possible."

calopre 08-09-10 07:54

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin for the treatment of major depressive disorder (MDD).

The Phase IIb study will assess Serdaxin’s efficacy as a treatment for major depressive disorder in approximately 300 subjects. The planned double blind, randomized, placebo-controlled trial will be conducted at multiple sites in the U.S. and will measure the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) as the primary efficacy endpoint.

"We look forward to starting this Phase IIb clinical trial and further investigating how Serdaxin’s novel action as a dual serotonin and dopamine enhancer may be able to provide a broader therapeutic effect with fewer side effects compared to currently marketed antidepressants," said Dr. Chang Ahn, Rexahn’s Chief Executive Officer.

In recent comments made about the promise of Serdaxin, Dr. Michael Thase, Professor of Psychiatry and Chief of the Division of Mood and Anxiety Disorders Treatment and Research Program at the University of Pennsylvania and Chairman of Rexahn’s scientific advisory board in MDD, said, "In my opinion, Serdaxin’s novel mechanism, which targets both serotonin and dopamine, coupled with the promising results of the recent proof of concept study, provide strong support for further clinical development of this well tolerated drug for treatment of depression."

NeoStem, Inc. (NYSE Amex: NBS) today announced that it has appointed Ian Zhang, Ph.D., MBA, as the new president and managing director of NeoStem (China), Inc. Dr. Zhang is the former Head of Asia Pacific Integration at Life Technologies, where he served on the steering committee managing the acquisition and integration of Applied BioSystems. He is also the former Head of Corporate Development (Asia Pacific) for Invitrogen responsible for growth strategy and acquisitions and integrations, where he had also managed the acquisition and integration of BioAsia, Dynal, Zymed, and Caltech by Invitrogen. Dr. Zhang also served as the President and General Manager for Dynal Biotech (Beijing) Ltd. (a wholly owned subsidiary of Invitrogen Corporation).

Cerus Corporation (NASDAQ:CERS) and Whittemore Peterson Institute for Neuro-Immune Disease (WPI) presented data at today's NIH-sponsored 1st International Workshop on XMRV which demonstrates the efficacy of Cerus' INTERCEPT Blood System to inactivate XMRV and other MLV-related viruses in donated blood. Recent scientific studies have detected these human retroviruses in up to seven percent of healthy blood donor samples, indicating approximately 20 million people in the United States could unknowingly be carrying the infection. XMRV and MLV-related viruses have been linked to prostate cancer and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

"The genetic variability of XMRV and MLV-related viruses will make development of screening assays for the blood supply challenging," said Dr. Judy Mikovits, director of research at WPI and lead author of the study. "The INTERCEPT technology demonstrates robust inactivation of these viruses and holds promise as a potential proactive approach to mitigating the risk of XMLV/MLV-related virus transmission via transfusion."

CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced initiation of the PROstate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer.

The open-label PROACT trial is being conducted at City of Hope, located just outside of Los Angeles, California, as well as multiple clinical sites in India. In the trial, approximately 50 patients with metastatic hormone-refractory prostate cancer who have failed first-line therapy with chemotherapy will receive orally available bafetinib twice daily. The trial endpoints are reduction in prostate-specific antibodies and increases in progression-free survival compared to baseline and historical data.

Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has entered into a long-term marketing and distribution agreement with Merck, S.A. de C.V. in Mexico for the distribution of one of the Company's proprietary over-the-counter products, Glucose RapidSpray brand formulated glucose spray product. Merck will market and distribute the product in Mexico as Diabion® GlucoShot®.

Intellect Neurosciences, Inc. (OTCBB:ILNS), announced that it has engaged Dr. Giora Feuerstein as a key consultant to advise the Company regarding its technology programs and pipeline. Until earlier this year, Dr. Feuerstein was Assistant Vice President & Head, Discovery Translational Medicine at Pfizer, having previously held these positions at Wyeth Research. Dr. Feuerstein resigned his position at Pfizer to focus on applying his expertise to assist smaller biopharmaceutical companies in meeting their drug development objectives via effective translational medicine strategies.

Dr. Daniel Chain, Chairman and Chief Executive Officer of Intellect, commented: "We are privileged and absolutely delighted that Dr. Feuerstein has taken an active interest in Intellect Neurosciences. Dr. Feuerstein's breadth and scope of experience in guiding biopharmaceutical research and translational medicine is simply unparalleled in the industry. Dr. Feuerstein is widely credited in relation to the extraordinary cardiovascular and neuroscience pipeline at Wyeth that drove the acquisition by Pfizer last year. His agreement to provide consulting services to Intellect brings a phenomenal set of skills to help the Company in its endeavors to develop innovative and safe disease-modifying drugs for the treatment of Alzheimer's disease and other serious conditions."

Dr. Feuerstein commented: "I am pleased to be able to contribute my knowledge and expertise to help Intellect Neurosciences, which has an exciting pipeline and abundance of innovative ideas to develop new biopharmaceutical products. Dr. Chain impressed me by his critical, objective and balanced scientific assessments that I personally appreciate and like. I am confident that, under this type of leadership, the Company will meet its important objectives focused on the development of innovative drugs that will provide meaningful medical benefits via disease-modifying mechanisms along with maximum safety."

RevMed (OTCBB:RMCP) has secured a binding 5 Year contract to produce 5M syringes/month of its 3mL fixed needle safety syringe with Medical Investment Group, LLC (MIG). MIG, a Massachusetts Limited Liability Company, will fulfill this obligation through its relationship with an internationally certified global medical device manufacturer. The manufacturer currently ships medical products throughout the world and is compliant with all major international standards including FDA, CE and Health Canada as well as those required in Japan, China and India. The factory is fully ISO compliant for medical device manufacturing and has comprehensive clean rooms, packaging and sterilization facilities. The factory has a current capability to scale up to 20 - 50 million syringes per month if required. First shipments for delivery are currently expected at the end of Q1/2011.

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company, today announced that Silenor® (doxepin) now is commercially available by prescription in the United States. Somaxon has implemented a wholesale and retail stocking program to disseminate Silenor 3 mg and 6 mg dosepacks to pharmacies across the United States. Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

"The commercial availability of Silenor, the first and only prescription product approved for the treatment of sleep maintenance insomnia that is not a controlled substance, is an important milestone for Somaxon and marks the completion of our product launch preparations," said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. "We look forward to promoting this highly differentiated product to healthcare providers alongside our co-promotion partner, Procter & Gamble. Our combined sales teams will begin full-scale, field-based promotion of the product on September 20, 2010, targeting approximately 35,000 physicians and 25,000 pharmacies across the U.S."

"In conjunction with the deployment of our field-based promotion to healthcare providers, we will launch a comprehensive marketing program that will utilize web-based initiatives and will be directed at both physicians not called on directly by our sales force as well as patients suffering from sleep maintenance insomnia," continued Pascoe. "This campaign will highlight the traits that we believe will position Silenor for success in the insomnia market – the ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential."

St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, and privately-held CardioMEMS today announced that they have reached an agreement under which St. Jude Medical will make a $60 million equity investment in CardioMEMS, a medical device company that has developed a wireless sensing and communication technology to assess cardiac performance. The agreement provides St. Jude Medical an immediate 19 percent ownership in CardioMEMS and the exclusive option to acquire the company for an additional payment of $375 million during the period that extends through the completion of certain commercialization milestones.

Teleflex Incorporated (NYSE:TFX) today announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the company’s ArrowEVOLUTION PICC with Chlorag+ard technology, a peripherally inserted central catheter with a Chlorhexedine-based solution that has been chemically-bonded into the surface of the catheter both intra- and extralumenally. Teleflex will launch the product for general availability in the United States in the fourth quarter.

Also Tuesday:


3SBio Inc. ("3SBio") (Nasdaq:SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products today announced its planned participation in the following investor conferences: Sep 9-10, 2010 Susquehanna Fourth Annual Beijing Management Summit Beijing Sep 13-14, 2010

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatm nts for central nervous system disorders, today announced that it will present at the following investor conferences: The Rodman & Renshaw Annual Global Investment Conference on Tuesday, September 14, 2010, at 12:30 p.m. Eastern Time at The New York Palace Hotel in New York City.

Action Products International, Inc. (PINKSHEETS:APII) announced today the company is in discussions for the completion of a reverse merger with or acquisition of a private company.

AGA Medical Holdings, Inc. (AGA Medical) (Nasdaq: AGAM) today announced that the company is scheduled to present at the Baird 2010 Health Care Conference being held at The St. Regis New York on Tuesday, September 14, 2010, at 2:15 p.m. ET. John Barr, President and Chief Executive Officer, will deliver the company's presentation.

AngioDynamics (NASDAQ:ANGO), a leading provider of innovative medical devices for the minimally-invasive treatment of cancer and peripheral vascular disease, today reported preliminary unaudited results for its fiscal 2011 first quarter ended August 31, 2010.

Array BioPharma Inc. (Nasdaq: ARRY) today announced that its Chief Executive Officer, Robert E. Conway, will speak at the Rodman & Renshaw Global Investment Conference and the Stifel Nicolaus Healthcare Conference.

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, announced today that the company is scheduled to present at the Rodman & Renshaw Annual Global Investment Conference, Monday, Sept. 13, 2010, at 10:25 a.m. Eastern Time in New York City.

Banyan Corporation (PINKSHEETS: BNYN) announced that it has reached an agreement with Mark Eric Bailey to partner with it in the development of its America's Dentist concept.

Baxter International Inc. (NYSE: BAX) announced today that it will present at the Morgan Stanley Global Healthcare Conference on Tuesday, September 14, 2010 at 8 00 a.m. (ET) or 7:00 a.m. (CT).

China PharmaHub Corp. (OTC Bulletin Board: CPHB) which recently merged with World Wide Relics (OTC Bulletin Board:WRLC) and, effective August 23, 2010, changed its name from World Wide Relics, Inc. to China PharmaHub Corp., announced today that effective Tuesday, September 7, 2010, its stock shall begin trading under the symbol "CPHB."

Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the Company is scheduled to present at the Rodman & Renshaw 12th Annual Healthcare Conference, September 12-15, in New York, NY.

Cobalis Corp. (Pink Sheets:CLSC) is pleased to announce that with our recent positive development of the PreHistin® distribution network and imminent marketing launch, we will be conducting our first series of investor conference calls.

CONMED Corporation (NASDAQ:CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in three investor conferences during the second week of September 2010 as follows:Morgan Stanley Global Healthcare Conference on September 14, 2010 at 3:20 PM Eastern, in New York City.

D. Medical Industries Lt . (NASDAQ:DMED) (TASE:DMDC) a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, today announced that Efri Argaman, the Company's Chief Executive Officer, will present an update on the Company's business at the Rodman & Renshaw 12th Annual Healthcare Conference on Tuesday, September 14, 2010 at 2:50 p.m. ET.

Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced the receipt of a signed trial agreement from the Baltimore VA Medical Center of Baltimore, Maryland.This will provide the Baltimore VA Medical Center with a Blood Volume Analyzer-100 (BVA-100), an instrument which enables semi-automated measurement of a patient's total blood volume, red blood cell volume and plasma volume.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that the company will be partici ating in the Rodman & Renshaw 12th Annual Global Investment Conference being held at the Palace Hotel in New York City from September 13th - 15th, 2010.

DUSA Pharmaceuticals, Inc.® (Nasdaq:DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, announced that Bob Doman, President and Chief Executive Officer, will present a corporate overview at the Rodman & Renshaw 12th Annual Healthcare Conference on Monday, September 13, 2010 at 10:50 a.m. ET at The New York Palace Hotel.

Dyadic International, Inc. (Pink Sheets:DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of specialty enzyme products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, today announced that Dyadic has received an additional $1 million to complete its previously announced private placement of convertible subordinated secured promissory notes which has provided Dyadic with total gross proceeds of $4 million.

Exact Sciences Corp. (Nasdaq: EXAS) today announced that it will present at two conferences during the week of Sept. 12.

Express Scripts, Inc. (Nasdaq:ESRX) announced that it will present at the following investor conferences in September:

GeckoSystems Intl. Corp. (PINKSHEETS:GCKO) announced today that they have successfully negotiated a Memorandum of Understanding (MOU) with a wholly owned contract manufacturing subsidiary of Dell, TriFusion LP.GeckoSystems is a dynamic leader in the emerging mobile robotics industry revolutionizing their development and usage with "Mobile Robot Solutions for Safety, Security and Service."

iCAD, Inc. (NASDAQ: ICAD), an industry-leading provider of advanced image analysis and workflow solutions for the early identification of cancer, today announced th t Ken Ferry, President and Chief Executive Officer and Darlene Deptula-Hicks, Executive Vice President and Chief Financial Officer, will be presenting a corporate update at the Rodman & Renshaw 12th Annual Global Investment Conference on September 15, 2010 at 10:25 a.m. (Eastern time) being held at the New York Palace Hotel in New York City.

La Jolla Pharmaceutical Company (OTCBB:LJPC) provided an update today that the Company is actively seeking and evaluating potential pharmaceutical roducts for in-licensing or acquisition and has engaged consultants to determine whether there is any potential for the further development of Riquent® for the treatment of lupus.

Mantra Venture Group Ltd. ('Mantra') (OTCBB:MVTG) (FRANKFURT: 5MV) is pleased to announce that Climate ESCO Ltd. (CE), a wholly owned subsidiary of Mantra, has secured a demonstration project using its new LED (Light Emitting Diode) lighting products for the District of North Vancouver.

Marina Biotech, Inc. (NASDAQ: MRNA), formerly known as MDRNA, Inc., a leading RNAi-based drug discovery and development company, announced today that it will present at the Rodman & Renshaw 12th Annual Healthcare Conference on Monday, September 13, 2010, at 3:15 p.m. Eastern Time (12:15 p.m. Pacific Time) at the New York Palace Hotel in New York City. J. Michael French, Marina Biotech President and Chief Executive Officer, will present a corporate overview and business update.

Medtronic, Inc. (NYSE: MDT) today announced CE (Conformit© Europ©enne) Mark approval and the first global use and launch of the Medtronic CoreValve® delivery system with AccuTrak Stability Layer for transcatheter aortic valve implantation (TAVI).

Mylan Inc. (Nasdaq:MYL) today announced it has completed the acquisition of Bioniche Pharma Holdings Limited sooner than anticipated. Bioniche Pharma, an injectable pharmaceutical company, is providing Mylan with immediate entry into the North American injectables market and a platform for the commercialization of future biosimilar product offerings.

NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders, today announces that it will report second quarter 2010 financial results on September 14, 2010, before the U.S. financial markets open.

Oragenics, Inc. (OTCBB: ORNI) announced today that its oral care probiotic EvoraPlus® is now expected to be available at corporate-owned GNC stores nationwide.

ProPhase Labs, Inc. (NASDAQ: PRPH), makers of the Cold-EEZE® brand of cold remedies, today announced it has retained Westport, CT based full-service media solutions company Women's Marketing, Inc. (WMI) as its agency of record.

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today, it will reschedule its annual shareholders' meeting originally scheduled on August 31, 2010.

Regenicin, Inc. (OTC Bulletin Board:WDSTD), a clinical-stage biotechnology company, announced today that it has named Craig Eagle, M.D. to its board of directors.

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that the Company will be participating in the Rodman & Renshaw 12th Annual Global Investment Conference being held at the Palace Hotel in New York City from September 13th - 15th, 2010.

Rite Aid Corporation (NYSE: RAD) and Save-A-Lot, a SUPERVALUE (NYSE: SVU) company, announced today that Rite Aid has entered into a licensing agreement with Save-A Lot to add the discount, limited assortment grocery store concept to Rite Aid’s ten existing stores in the Greenville, SC, market.

RXi Pharmaceuticals Corporation (Nasdaq: RXII), a recognized leader in RNAi-based therapeutic discovery and development, today announced that the Company's President and Chief Executive Officer, Noah D. Beerman, will present a corporate overview at the Rodman & Renshaw Global Investment conference on Monday, September 13, 2010 at 2:50 p.m. ET in New York City.

Skystar Bio-Pharmaceutical Company (NASDAQ: SKBI) a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, announces update regarding its Hubei acquisition.

ViroPharma Incorporated (Nasdaq:VPHM) today announced that William Roberts, vice president, corporate communications of ViroPharma, will present at the Stifel Nicolaus 2010 Healthcare Conference at 9:10 A.M. ET on Wednesday, September 15, 2010. The conference is being held at the Four Seasons in Boston.

VirtualScopics, Inc. (Nasdaq:VSCP), a leading provider of quantitative imaging for clinical trials, today announced it has entered into a scientific collaboration, specific to molecular imaging, with ABX-CRO, a Dresden, Germany based full-service contract research organization.

XenoPort, Inc. (Nasdaq:XNPT) announced today that it will provide access via the World Wide Web to its presentation at the Morgan Stanley Global Healthcare U plugged Conference.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.




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Last Updated on Tuesday, 07 September 2010 19:01

calopre 08-09-10 13:04

CLDX: CellDex Therapeutics Hammered After Divorce With Pfizer, Time to Buy? PDF | Print | E-mail
Written by Vinny Cassano
Wednesday, 08 September 2010 00:00
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Shares of CellDex Thereapeutics were slammed late last week after Pfizer backed out of an over two-year-old licensing agreement for CDX-110, a cancer vaccine currently being tested for effectiveness in fighting one of the most aggressive forms of brain cancer. CDX-110 is CellDex's most advanced product candidate, currently being evaluated in the latter stages of an ongoing Phase II trial.
After having traded near ten dollars over the past year, CLDX collapsed to below the three dollar mark for a brief time on Friday before recovering somewhat to settle in the mid three dollar range. Over seven million shares traded hands, signifcantly higher than the average of roughly 600,000, and the company's market cap closed last week at 112.56 million.


CELLDEX THERAPEUTIC
3.47 -0.06 (-1.70%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.




Celldex Therapuetics: Bottom play with upcoming catalysts

After such a dramatic drop on just as dramatic news, the million dollar question now is whether it's time to buy, time to hold, time to run or time to sit on the sidelines and watch for a little while.

My take is this.. There are two scenarios at play here:

1. Pfizer has lost confidence that CDX-110 is effective enough to make it through Phase III and onto utlimate approval and decided to cut the cord (and cash burn) sooner rather than later, or

2. The truth is in the published reports and Pfizer decided that CDX-110 was no longer - or never was - a strategic fit for the company's, especially not for the pricetag attached to the potential royalty payments.

There is also some grey area built into these scenarios that may have influenced Pfizer's decision; the company may have decided that the competition for brain cancer vaccines was a lot thicker at this time than it was at the time of signing the partnership and Pfizer also may have felt that they could advance similar products of their own with technology already indiginous to the company, and save the big bucks that would have been paid to CellDex in the process.

The second scenario is definitely a lot more positive - and maybe even more probable - than the first, but regardless of whatever decision an investor makes at this point, he or she must keep both scenarios in mind because it's all speculation at this point.

It's also worth keeping in mind that regardless of which scenario is at play here, we've got to expect that CellDex - barring the addition of another deep-pocketed partner - will need to raise cash to advance this product through Phase III. That means dilution is likely in the near to mid term future.

So let's weigh it up.

The Good:

- A speculative 'Phase II' company with multiple cancer treatments in the pipeline in addition to a few earlier-stage candidates that treat various infectious and inflammatory diseases.

- A large decline in price already occurred, meaning the worse may be over since a market cap of 112.5 is not an unreasonable buy for a speculative company with the solid pipeline of CellDex.

- Should CDX-110 make it to market, then the company will not be looking at sharing revenue with Pfizer (although another partnership deal could materialize).

The Bad:

- CellDex's most advanced product just got dumped by one of the world's largest pharmaceutical giants.

- Speculation will run rampant about what Pfizer knows that we don't.

- Dilution is almost a sure thing.

The Ugly:

- The huge price decline last week.

- The fact that Pfizer might have dumped the agreement because there's little chance of success.

I'm a fan of a speculative buy here, although I wouldn't be ready to jump all in at once. I'd wet my beak (I've got a big nose) with a few shares and keep CLDX high on the watch list to see if a better 'accumulate' point presents itself. If a better entry point did present itself, I'd add a few more shares, but I'd still hold off investing the full intended amount until the future financing played out.

I think we're looking at a decent speculative buy, but I wouldn't get in all at once.

calopre 09-09-10 01:18

What the Merck Deal Could Mean for Generex PDF | Print | E-mail
Written by Vinny Cassano
Wednesday, 08 September 2010 00:00
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Generex (NASDAQ:GNBT) announced a move into the Mexican market on Tuesday when the company issued a press release detailing a marketing and distribution agreement with Merck S.A. de C.V. Merck has agreed to market and distribute Generex's 'Glucose RapidSpray' product in Mexico

under the name 'Diabion GlucoShot.' RapidSpray is already on sale in retail pharmacies in both the United States and Canada, and Tuesday's PR also mentions the Middle East as a current retail location. Generex is also preparing to introduce the product into additional Latin and South American countries before possibly going worldwide with RapidSpray.

This distribution agreement with Merck - undoubtedly a huge player in the global pharmaceutical market - hit the streets not long after Generex announced that Doctor Craig Eagle was named to the company's scientific advisory board.

Dr. Eagle's appointment alone stirred the speculative pot because he is also serving as the Vice President of Strategic Alliances and Partnerships for the Oncology business unit at Pfizer Inc, so combine the Merck news with the Pfizer news and it looks like Generex is starting to rub elbows with the big boys.

The most obvious of speculative theories, at this point, would have Merck making a move towards the diabetes side of the Generex pipeline with Pfizer possibly moving into the cancer side. While I do understand the argument that there could be something to that theory, I do belive that it's still a bit early to completely buy off on such large scale event, but hey - the time is ripe for mergers & acquisitions right now, so one speculative train of thought is just as good as another's.

The Pfizer connection with Genrex is intriguing, as Pfizer just kicked CellDex and its cancer vaccine to the curb. Is it possible that Pfizer is looking to partner with another company in the cancer vaccine market (such as Generex), or is the company looking to move away from the still-risky cancer immunotherapy pipelines? CellDex didn't fit into Pfizer's strategic future, so for them to partner with another company in the cancer vaccine field, they'd have to find that product (and the licensing deal) to be significantly superior to the one at CellDex.

I'm still sceptical that anything will materialize with Pfizer as many are speculating, but I'm paying attention.

The same can be said for the Merck distribution deal, although I believe that there might be something more here. I'll admit that the RapidSpray news took me by surprise. I never expected that a powerhouse pharma would agree to market and distribute that product.

RapidSpray does have some market potential, in my opinion, but I didn't think that potential was on a scale to attract Merck, so I'm inclined to believe that there might be something more going on that we don't know about yet. RapidSpray has been an afterthought, for the most part, with the real potential lying with Oral-lyn. However, it could be that Merck is getting its foot in the door now while waiting on Oral-lyn Phase III updates or results.

This could be a developing story worth watching.

Regardless of which side of the Generex fence you stand on, I think you've got to respect the fact that the recent news bits involving Merck and Pfizer - although neither really that significant at this time - does return some legitimacy to Generex after that legitimacy was questioned by many after the stock price collapsed in the midst of hostile attacks from former friends, enemies, and a slew of bashers that look to create a mood of fear, panic and ucnertainty around the stock in cyberspace.

Nothing groundbreaking has occurred just yet, but this story is definitely worth watching and could still be developing. I liked the recent events enough to add some more shares, even though I wasn't going to buy for above forty cents until we heard an outcome of the most recent reverse split vote.

But hey, forty, forty two cents - the difference there is just a Bazooka Joe, so why not?

Disclosure: Long GNBT
Vinny also authors the popular stock investing blog, VFC's Stock House.

calopre 09-09-10 09:40

Viking soars on 510k clearence. ImmunoCellular announces positive data. MAP surges on migraine study. After the bell: Santarus in license deal. Questcor reports FDA delay PDF | Print | E-mail
Written by BioMedReports.com Staff
Wednesday, 08 September 2010 18:29
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Below is a list of the companies that made news in the healthcare sector on Wednesday, September 08, 2010.


Santarus, Inc. (NASDAQ: SNTS), S2 Therapeutics, Inc. and VeroScience LLC today announced after the bell that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET (bromocriptine mesylate) tablets in the U.S. CYCLOSET is a prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as mono-therapy and in combination with other oral antidiabetic agents. Santarus expects to commercially launch CYCLOSET in November 2010.

CYCLOSET is the first FDA-approved drug for patients with type 2 diabetes to target the activity of dopamine, a chemical messenger between neurons within the central nervous system. The precise mechanism by which CYCLOSET improves glycemic control is unknown, but basic science research suggests that the active agent in CYCLOSET acts to reset aberrant central neuro-metabolic control of peripheral metabolism towards normal in diabetic patients resulting in a reduction in insulin resistance. In clinical studies, once daily, morning administration of CYCLOSET improved glycemic control, as demonstrated by a significant reduction in mean HbA1c (0.4 – 0.9%, data on file), and improved postprandial glucose levels without increasing plasma insulin concentrations in patients with type 2 diabetes.

Shares of Santarus rallied after the bell, gaining nealy 10% or 22 cents to $2.44.

Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) today announced that the U.S. Food and Drug Administration (FDA) has informed Questcor that the FDA will require additional time beyond the current action date of September 11, 2010 to complete its review of Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS). In conjunction with the FDA's review of this sNDA, Questcor and the FDA have been updating and modernizing the product label for Acthar, which has not been modified since 1978, when multiple sclerosis was added to the label. This step of the review process is now complete. Questcor has been notified that the FDA needs some additional time to finalize the wording on the label, review the proposed medication guide, and define post-approval commitments, if any, for the IS indication.

In extended trading, shares of Quest fell more than 5%.

Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced that it is offering to sell 8.3 million shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering. Barclays Capital Inc. is the sole book-running manager of the offering and Halozyme has granted the underwriter a thirty (30) day option to purchase up to 1,245,000 additional shares. Halozyme intends to use the net proceeds from the offering for general corporate purposes and to support further research and development of its product candidates.

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) announced after the market closed today that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis. Both sanofi-aventis and Regeneron management and staff remain blinded to the interim study results.

"We look forward to the final results of the trial, which are expected in the second half of 2011 with belief that the combination of aflibercept and FOLFIRI has the potential to benefit patients with this difficult-to-treat disease," said Tal Zaks, Head of Development, Global Oncology Division, sanofi-aventis.

Earlier Wedmnesday:


Jed Kennedy, Viking President & CEO said, "We are very pleased to have received timely FDA 510(k) clearance of our Next Gen system for a broad base of minimally invasive procedures including general surgery, urology, gynecology, spinal, bariatric, ENT and thoracic." Kennedy went on to say, "With the 510(k) in place, we will now focus on completing the documentation required to apply the CE mark to the 3DHD system." The CE mark demonstrates compliance with the European community's Medical Device Directive.

Shares of Viking soared 50% or 14 cents to $0.42.

ImmunoCellular Therapeutics (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced long-term data from a Phase I clinical trial of ICT-107, the Company’s lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The data show six out of 16 (37.6%) patients who received ICT-107 were disease-free after more than two years, with three of these patients (18.8%) remaining disease-free for more than three years. One of these patients remains disease-free after almost four years. No treatment-related serious adverse events have been observed to date.

"These data continue to demonstrate the potential of targeting cancer stem cells to significantly delay disease recurrence and thereby increase survival in GBM," said Manish Singh, Ph.D., president and CEO of ImmunoCellular Therapeutics. "Glioblastoma is a devastating disease that is associated with a two-year progression-free survival rate of approximately 11%, and a three-year progression-free survival rate of less than 5%. We are therefore highly encouraged by the substantially extended progression-free survival rates we have seen thus far, which we expect to increase as we continue gathering data from this study. We look forward to further investigating the potential of ICT-107 in a larger Phase II clinical study, which we are on track to commence later this year."

The Phase I clinical study was conducted in 16 newly diagnosed glioblastoma patients, who received three injections of ICT-107 in addition to standard treatment with surgery, radiation and chemotherapy. Earlier this year, the Company reported two-year survival rates of 80% in study patients, which compares favorably to the historic median two-year survival rate of 26.5% with standard of care alone. The study’s median progression-free (PFS) survival of 17.7 months compared especially favorably to the historic median PFS of 6.9 months. Eleven of the 16 patients continue to survive. No serious adverse events have been reported and minor side effects have been limited to fatigue, skin rash and pruritis.

Shares of ImmunoCellular surger more than 15% on the news.

MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) today reported results from a pharmacodynamics (PD) trial comparing the acute effects on pulmonary artery pressure of LEVADEX, dihydroergotamine mesylate (DHE) administered intravenously (IV) and placebo. In the trial, there was no statistically significant difference between the LEVADEX and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

LEVADEX was well tolerated and there were no drug-related serious adverse events reported. There were no clinically significant changes in any cardiovascular parameters measured in this trial. There were no mean increases in QT interval in the LEVADEX group. All pharmacokinetic results in this trial were consistent with those reported in previous LEVADEX trials.

"Intravenous DHE has been used safely for over 60 years, and we wanted to evaluate whether LEVADEX, with its novel administration through the lung, would have an effect on pulmonary artery pressure. We are pleased to report that LEVADEX did not have an effect on pulmonary artery pressure compared to placebo and was, in fact, less than that seen with IV DHE," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals.

Shares of MAP shot up more than 18% or $2.20 to $13.01.

AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based therapeutics, announced today that the United States Patent and Trademark Office issued AVI a patent granting key claims covering the use of phosphorodiamidate morpholino based oligomers (PMOs) as antibacterial agents. The patent, titled Antisense Antibacterial Method and Compound (No. 7,790,694), contains broad claims for the use of peptide-conjugated phosphorodiamidate morpholino oligomers (PPMOs) to target the acyl carrier protein (AcpP), a gene considered essential for bacterial growth in both gram positive and gram negative bacteria.

DARA BioSciences (Nasdaq:DARA) announced today that it presented study results from its Phase 2 multicenter, placebo controlled, double-blind, randomized dose escalation study for KRN5500.

The study was designed to evaluate the safety and efficacy of KRN5500 for treatment of neuropathic pain in patients with cancer, and primary endpoint results from the study have previously been released.

Prevalence of Chemotherapy-induced Peripheral Neuropathy (CIPN) is reported to be as high as 38% in patients who receive multi-agent chemotherapy. Presently, there is no approved treatment for this indication; thus, exploratory analyses of a subset of study patients with CIPN (17 of 19 total) provides clinically meaningful information regarding KRN5500 as potential treatment for CIPN.

Marshall Edwards, Inc. (Nasdaq:MSHL), an oncology company focused on the clinical development of novel anti-cancer therapeutics, announced today that it has reached an agreement in principle with Novogen Limited (ASX: NRT; Nasdaq: NVGN) to acquire Novogen's entire isoflavone-related intellectual property portfolio in a stock-based transaction. Specific terms of the proposed agreement were not disclosed.

NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, will deliver four poster presentations on its compounds at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The conference will take place September 12-15, 2010 at the Boston Convention and Exhibition Center in Boston, MA.

The presentations will highlight new data developed from studies of NovaBay's Aganocide family of compounds, which have shown to be highly effective against bacteria, including multi-drug resistant strains (e.g. MRSA), viruses and fungi in preclinical testing. Additionally, NovaBay's lead Aganocide, NVC-422, has recently demonstrated efficacy in a 129 patient dose-ranging Phase 2 clinical trial for the treatment of impetigo, a highly contagious skin infection affecting over 1.3 million patients in the U.S. annually.

Shares of NovBay jumped 27 cents or 16% on the news.

Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced that it has entered into an exclusive agreement with Ono Pharmaceutical Co., Ltd. to develop and commercialize two compounds from Onyx's proteasome inhibitor development program, carfilzomib and ONX 0912. Under the terms of the agreement, Ono has exclusive rights to develop and commercialize both compounds for all oncology indications in Japan. Onyx retains commercialization rights in other countries in the Asia Pacific region, as well as in all other regions of the world, including the U.S. and Europe. The potential value of the transaction, which includes rights to all oncology indications for the two molecules, is estimated to exceed $300 million, plus royalties.

Stereotaxis, Inc. (Nasdaq:STXS) highlighted significant new additions to the body of evidence demonstrating exceptional clinical outcomes achieved with its Niobe® Magnetic Navigation System in ventricular tachycardia (VT) ablation.

At the European Cardiology Society Annual Congress in Stockholm last week, the research team led by Dr. Tamas Szili-Torok from the Erasmus Medical Center in Rotterdam presented the first comparative trial in a prospective study of 64 consecutive VT patients, comparing Stereotaxis VT ablation to conventional, non-magnetic ablation. Acute success was achieved in 97% of the Stereotaxis VT ablation group versus 81% of the manual ablation group. Patients in the Stereotaxis VT group averaged 50% less x-ray exposure, and after a year, only 14% VT recurrence, versus a 50% recurrence rate among manual ablation patients. A remarkable 25% reduction in total procedure time was achieved in the Stereotaxis VT group compared to the manual group.

ULURU Inc. (NYSE Alternext: ULU) announced today that it has signed a worldwide distribution agreement appointing Novartis the exclusive distributor of a veterinary version of Altrazeal® for marketing to the animal health sector.

Under the terms of the agreement ULURU will supply Novartis with finished product for marketing in the global markets. The agreement includes other wound care products that may be developed by ULURU that the parties mutually agree to be covered by this agreement.

Commenting on the agreement, Kerry P. Gray, President and CEO of ULURU, stated, "We are very pleased to be working with Novartis, a leading global animal health care company and one of the top 5 pharmaceutical companies in the world. Initial wound healing testing in animals with Altrazeal® produced positive results. We look forward to working with the Novartis team to establish our wound franchise as a leader in the veterinary market."

Shares of ULURU jumped more than 15% on the news.

Also Wednesday:

Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced that Michael R. Minogue, Chairman, President and Chief Executive Officer, will present at the Morgan Stanley 2010 Global Healthcare Conference on Monday, September 13, 2010 at 3:55 p.m. ET.

Biogen Idec Inc. (NASDAQ: BIIB) announced today that its presentation at the 2010 Morgan Stanley Global Healthcare Unplugged Conference will be webcast live on Monday, September 13, 2010 at 9:10 a.m. EDT.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today held its own version of a traditional groundbreaking ceremony with an event it called "Raising the Roof."

Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology markets, today announced that it will present a corporate overview at the Stifel Nicolaus 2010 Healthcare Conference at the Four Seasons in Boston on Thursday, September 16, 2010, at 1:30 p.m. Eastern Time.

EpiCept Corporation (Nasdaq : EPCT) today announced Jack Talley, President and CEO, will be presenting at the Rodman & Renshaw 12th Annual Global Investment Conference on September 13, 2010 at 2:25 p.m. Eastern Time at The New York Palace Hotel in New York.

Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced that it is offering to sell 8.3 million shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering. Barclays Capital Inc. is the sole book-running manager of the offering and Halozyme has granted the underwriter a thirty (30) day option to purchase up to 1,245,000 additional shares.

Helicos BioSciences Corporation (NASDAQ: HLCS) announced today that it has filed a lawsuit against Pacific Biosciences of California, Inc. for patent infringement.

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Kendle (Nasdaq:KNDL), a leading, global full-service clinical research organization, today announced the Company will participate in the upcoming Robert W. Baird & Co. 2010 Health Care Conference on Sept. 14, 2010 at the St. Regis New York in New York City.

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) today announced that David P. King, Chairman and Chief Executive Officer, is scheduled to speak at the Bank of America Merrill Lynch Investment Conference in San Francisco, CA.

Luminex Corporation (Nasdaq:LMNX), today announced that initial results from a study conducted at the NMI Natural and Medical Sciences Institute at the University of Tubingen in Germany demonstrate that its MAGPIX® system provides more cost effective and efficient results than a conventional microtiter plate based ELISA method.

Obagi Medical Products, Inc. (NASDAQ:OMPI), a leader in topical aesthetic and therapeutic skin health systems, announced today that Company management will present a corporate overview at the following three investor conferences: The Robert W. Baird & Company 2010 Health Care Conference to be held at the St. Regis Hotel in New York City.



Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer of microRNA-based molecular diagnostics, today reported financial results for the three and six months ended June 30, 2010.

Trubion Pharmaceuticals, Inc. (Nasdaq:TRBN) today announced that the U.S. Department of Justice and Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to the planned acquisition of Trubion by Emergent BioSolutions Inc. (NYSE:EBS) announced on Aug. 12, 2010.

calopre 09-09-10 09:48

a mio modo di vedere
aggiornamento portafoglio
exas
myrx
eln
anpi

calopre 09-09-10 17:06

Citazione:

Originalmente inviato da calopre (Messaggio 26454525)
a mio modo di vedere
aggiornamento portafoglio
exas
myrx
eln
anpi

avete visto exas

calopre 09-09-10 19:15

FDA needs additional time for Questcor Pharmaceuticals' review PDF | Print | E-mail
Written by Patrick Crutcher
Thursday, 09 September 2010 04:02
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Investors who may have missed the initial ride on QCOR's run up have been gifted another opportunistic entry point.

On Wednesday, Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) announced after-hours that the “FDA will require additional time beyond the current action date of September 11, 2010 to complete its review of Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS).” Additionally, QCOR and the FDA have been updating and modernizing the product label for Acthar, which has not been modified since 1978, when multiple sclerosis was added to the label, which is now complete.

QCOR was notified that the FDA needs some additional time to finalize the wording on the label, review the proposed medication guide, and define post-approval commitments, if any, for the IS indication.



QUESTCOR PHARM
9.85 -0.53 (-5.11%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.We want to reiterate that we believe QCOR will receive approval. The risk of a non-approval has been mitigated by the fact that this is their 3rd attempt at approval and Acthar is a well-understood drug. They received an overwhelming 22-1 vote in favor of approval. There were some lingering questions about some of the adverse events seen in the trial, however, as the panelists noted the efficacy far outweighed the risks. Additionally, much of what was discussed in regards to safety, concerned labeling and how to mitigate some risk by having a clear and concise inserts to assist physicians.

Labeling can be cooperatively done between the FDA and QCOR. This is a patient population that needs effective solutions for this rare and serious disorder, which effects roughly 1 out of .

We see no reason for non-approval and QCOR has been actively working with the FDA, which is a very positive sign. Beyond this, QCOR is still a profitable company and will likely see a boost in earnings(5-10%) with approval. They also noted third quarter 2010 prescription and sales levels were encouraging. So for those still interested in QCOR, today’s news should be a gift.

Shares of the company closed Wednesday's session at 10.38 +0.76 (7.90%), but given the news after hours, the stock began to fall to $9.80 -0.58 (-5.59%)

You can find our initial report on QCOR at the link below:
http://biomedreports.com/articles/mo...-decision.html



Disclosure: No Positions

calopre 10-09-10 18:08

opexa buon prezzo, prossime novità,a guida novartis

calopre 11-09-10 12:45

K-V Pharma to relaunch product, shares soar. Revolutions Medical nabs DOD contract. After the bell: Aria to provide update PDF | Print | E-mail
Written by BioMedReports.com Staff
Friday, 10 September 2010 18:25
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Below is a list of the companies that made news in the healthcare sector on Friday, September 10, 2010.


After the bell Friday, shares of ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) jumped more than 5% after the company announced that it will hold an investor conference call at 9:00 a.m. (ET) on Monday, September 13, 2010 to provide an update on the clinical development of its investigational pan-BCR-ABL inhibitor, AP24534. Harvey J. Berger, M.D., chairman and chief executive officer, will host the call along with other members of the ARIAD management team. The Company will announce the highlights in a press release to be issued before the market opens on September 13, 2010 prior to the conference call.

NexMed, Inc. (Nasdaq:NEXM), after the market close today announced the results of its Special Meeting of Stockholders, held today, Friday, September 10, 2010.

At the Special Meeting, the Stockholders of the Company approved, by an affirmative majority vote, to change the name of the Company from NexMed, Inc. to Apricus Biosciences, Inc. ("Apricus Bio"), effective September 10, 2010. The name change was brought on to reflect the broader focus of the Company’s development programs. The Company’s common stock will commence trading under the symbol, NASDAQ: APRI, effective at the open of the market on Tuesday, September 14, 2010.

Seattle Genetics, Inc. (NASDAQ:SGEN) today announced that its management will host a conference call and webcast on Monday, September 13, 2010, at 5:30 a.m. Pacific Time (PT) / 8:30 a.m. Eastern Time (ET) to discuss top-line results from its lintuzumab (SGN-33) phase IIb clinical trial in acute myeloid leukemia (AML).

In news from earlier in the day:

K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has received notice from the U.S. Food and Drug Administration of the successful completion of an inspection of the Company's facilities and approval to return its first product to market. Under the Company's Consent Decree, successful FDA inspections of the Company's quality systems, processes and facilities are expected to be required before K-V is permitted to resume manufacturing and shipment of particular products. During the week of August 16, 2010, the FDA undertook an inspection of the Company's quality systems, manufacturing processes and facilities focusing on the first product dosage form for reintroduction by the Company into the marketplace. The inspection was successfully completed.

The Company received notification from the FDA on September 8, 2010 of approval to ship into the marketplace the first product approved under the consent decree, i.e. Potassium Chloride. The Company expects that initial shipments of its Micro-K®10mEq and Micro-K® 8mEq will begin the week of September 13, 2010. The FDA is expected to conduct additional inspections with respect to other Company products before deciding whether other products may be manufactured and marketed.

Greg Divis, President of Ther-Rx Corporation and Interim President and Chief Executive Officer of K-V Pharmaceutical Company, stated, "Today marks a significant milestone in our efforts to restore business operations at K-V. The successful FDA inspection of our facilities and approval of our return to market demonstrates our hard work and commitment to meeting and sustaining current Good Manufacturing Practices requirements. We are committed to continuing to move K-V through further successful inspections and to obtain additional product approvals from the FDA."

Shares of K-V nearly doubled on the day, jumping $1.25 or nearly 75% higher to close at $2.94.

Revolutions Medical Corporation (OTCBB:RMCP) to receive contract with the United States Department of Defense HIV/AIDS Prevention Program (DHAPP) for multiple countries for its proprietary 3cc RevVac Safety Syringe.

Revolutions Medical is a safety medical device and software application company. Its products include the RevVac safety syringe (FDA approved), safety blood drawing device and safety IV catheter. The Company also provides RevColor, RevDisplay and Rev3D -- software solutions and proprietary tools that are compatible with standard MRIs and standard PACS. The software suite's functionality includes sorting of images, color, 3D and automatic segmentation of images.

On nearly 10 times the daily average volume, shares of Revolutions soared more than 31% or 30 cents to close the day at $1.275.

China-Biotics, Inc. (Nasdaq:CHBT) a leading developer, manufacturer and distributor of probiotics products in China, today confirms that there has been an organized effort to distribute false rumors regarding the Company by emails, phone calls and websites. The Company suspects this is motivated by short selling interest in the Company's stock. These messages are false and damage China-Biotics' corporate image and its management's credibility. The Company has acted in a legal and ethical manner and it has not provided false disclosures of the Company's operations or financial data to investors or the United States securities authorities. China-Biotics is working with its legal counsel and the relevant authorities on further action against those responsible.

The Medicines Company (NASDAQ:MDCO) announced today that the U.S. District Court for the Eastern District of Virginia denied APP Pharmaceuticals, LLC's motion to intervene for the purpose of appeal in a case between The Medicines Company and the U.S. Patent and Trademark Office (PTO), the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services.

The Court ruled on August 3 ordering the U.S. Patent and Trademark Office (PTO) to consider The Medicines Company's Angiomax® (bivalirudin) patent term extension application timely filed. The lawsuit challenged the PTO's denial of the application for an extension of the term of U.S. Patent No. 5,196,404, the principal U.S. patent that covers Angiomax.

Also Friday:

ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the 2010 Stifel Nicolaus Healthcare Conference on September 17, 2010 at 11:30 a.m. and at the UBS Global Life Sciences Conference on September 20, 2010 at 12:30 p.m.

Bristol-Myers Squibb Company (NYSE: BMY) is commencing today, through its wholly owned subsidiary Zeus Acquisition Corporation, a cash tender offer to purchase all out tanding shares of common stock of ZymoGenetics, Inc. (NASDAQ: ZGEN). Bristol-Myers Squibb announced on Tuesday, September 7, 2010 its intent to acquire ZymoGenetics.

.

China Cord Blood Corporation (NYSE:CO) China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced unaudited financial results for the first fiscal quarter ended June 30, 2010.

China Jo-Jo Drugstores, Inc. (NASDAQ:CJJD) which operates a retail pharmacy chain in Zhejiang Province, today announced that the Company will present at the Rodman & Renshaw Annual Global Investment Conference at The Palace Hotel in New York City on Monday September 13, 2010 at 3:15pm Eastern time.

Cortex Pharmaceuticals, Inc. (OTCBB: CORX) President and CEO, Mark A. Varney, Ph.D., will present at Rodman & Renshaw's 12th Annual Healthcare Conference at 3:40 PM (EDT) on Monday, September 13, 2010 in the Fahnestock Salon at the New York Palace Hotel in New York City.

Covance Inc. (NYSE:CVD) today announced that it will present at the Morgan Stanley Global Healthcare Conference on Tuesday, September 14, 2010 at 2:10 p.m. ET.

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced it supports the U.S. Food and Drug Administration's (FDA) labeling changes for gadolinium-based contrast agents for patients with acute kidney injury or chronic, severe kidney disease.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that 47 presentations at the 2010 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston from September 12-15 will cover recent research related to its marketed antibiotic, CUBICIN® (daptomycin for injection), as well as the company's clinical and preclinical antibiotic programs.


Deltagen, Inc. (Pink Sheets:DGEN), a leading provider of drug discovery tools to the biopharmaceutical industry, today reported unaudited consolidated financia results for the three months ended June 30, 2010.

Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical company, today announced the resignation of its Chief Financial Officer, Mario Crovetto, effective January 2011.


Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that its presentation at the 2010 Morgan Stanley Global Healthcare Unplugged Conference will be webcast and may be accessed at www.hgsi.com.

Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announce today that it will host a conference call on Monday, September 13, 2010, at 8:30 a.m. Eastern Time to update investors on clinical trial results and plans for further studies.

Orexigen® Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the Company will be speaking at the Rodman & Renshaw Annual Global Investment Conference.

Orthofix International N.V., (NASDAQ:OFIX) announced today that it will participate in the Stifel Nicolaus 2010 Healthcare Conference in Boston.

Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced today that it will present at the UBS Global Life Sciences Conference in New York Nancy Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, is scheduled to present on Monday, September 20, 2010, at 3:30 p.m. Eastern Time, at the Grand Hyatt New York Hotel, 109 East 42nd Street at Grand Central Terminal, New York, NY 10017.

Palatin Technologies, Inc. (NYSE Amex:PTN) announced that it will be presenting at the Rodman & Renshaw Annual Global Investment Conference / 12th Annual Healthcare Conference on Tuesday, September 14, 2010 at 10:50 AM ET.


PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today announced that the Company will present at the Stifel Nicolaus Healthcare Conference on Friday, September 17 at 10:55 am Eastern Time at the Four Seasons Hotel in Boston.

PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Michael J. Culotta, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the Credit Suisse 1st Annual Small & Mid Cap Conference 2010 in Boston on Wednesday, September 15, 2010, at 1:50 p.m. Eastern Time.



Seattle Genetics, Inc. (NASDAQ:SGEN) today announced that its management will host a conference call and webcast on Monday, September 13, 2010, at 5:30 a.m. Pacific Time (PT) / 8:30 a.m. Eastern Time (ET) to discuss top-line results from its lintuzumab (SGN-33) phase IIb clinical trial in acute myeloid leukemia (AML).


Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) will host a live audio webcast at the Morgan Stanley Global Healthcare Conference with Eyal Desheh, Chief Financial Officer, Teva Pharmaceutical Industries Ltd., presenting on Tuesday, September 14, 2010 in New York City.

TomoTherapy Incorporated (NASDAQ :TOMO), maker of advanced radiation therapy solutions for cancer care, today announced that CFO Thomas Powell and Vice President of Operations and Business Development Eric Schloesser will present at Baird's 2010 Health Care Conference on Wednesday, September 15, 2010 at 11:00 a.m. ET.

Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that Mark Corrigan, President and CEO is scheduled to present at the Rodman and Renshaw Annual Global Healthcare Conference at 4:30pm EDT on September 14, 2010, at the New York Palace Hotel.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

calopre 12-09-10 16:18

Opexa to Present at the Rodman & Renshaw 12th Annual Healthcare Conference on September 14, 2010 PDF | Print | E-mail
Wednesday, 08 September 2010 04:02
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THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin®, a personalized T-cell immunotherapy for multiple sclerosis (MS), today announced tha Neil K. Warma, Opexa’s President and Chief Executive Officer, will deliver a corporate presentation at the Rodman & Renshaw 12th Annual Healthcare Conference. The conference will be held September 12-15, 2010 at the New York Palace Hotel in New York City.

Opexa’s presentation will occur at 4:30 p.m. (EDT) on Tuesday, September 14, 2010 in the Hubbard Salon (5th Floor) of the New York Palace Hotel and will include an overview of the Company’s ongoing clinical development program for Tovaxin, the Company’s lead therapy for MS. The presentation will be webcasted and the link to access the audio webcast and presentation will be available at the Investor Relations page of the Company’s website at www.opexatherapeutics.com.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The Company’s leading therapy, Tovaxin®, is a personalized cellular immunotherapy treatment that is in clinical development for multiple sclerosis (MS). Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time.

Opexa completed its 150 patient Tovaxin for Early Relapsing Multiple Sclerosis (TERMS) Phase 2b clinical study in late 2008 which was one of the first clinical studies investigating an autologous T-cell therapy in MS patients. Data from this clinical study show evidence that Relapsing Remitting MS (RRMS) patients treated with Tovaxin saw overall clinical and disability benefits over the placebo group, including a clinically relevant decrease in the Annualized Relapse Rate (ARR), and improvement in disability score (EDSS), as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.

For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.
forse la più promettente azienda di staminali,potrebbe arrivare molto in alto
o sfiorire come tante altre promesseOK!OK!

calopre 13-09-10 15:13

Alexza Pharmaceuticals continues to look bullish PDF | Print | E-mail
Written by M.E.Garza
Monday, 13 September 2010 05:21
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With an FDA decision is due in early October and Alexza Pharmaceuticals' stock has been reacting very nicely in anticipation- making a string of higher highs and higher lows since early August.

Last week, the Company issued a press release announcing that it will participate in two investor conferences. One at the Rodman & Renshaw Annual Global Investment Conference tomorrow, September 14, 2010 at 3:40 p.m. ET, and the other at the JMP Securities Healthcare Conference on Monday, September 27, 2010 at 2:00 p.m. ET.

As subscribers to our FDA catalyst calendar already know, however, the real news for this company- is their pending FDA New Drug Application Decision for Staccato loxapine (AZ-004).

Alexza Pharmaceuticals looks like it still has plenty of room to rise before hitting a bit of resistance at $3.33 and $3.90 with some nice support at at $3.15 (right under it's close of $3.16 during Friday's session).

calopre 13-09-10 17:00

elan forse tenta di avviarsi a quotazioni più confacenti alla qualità del titolo

ales86 13-09-10 18:14

Bravo Calopre!! Non mi ero proprio accorto che l avevi citata.. Io la conosco da ben un anno. Oggi notiziola bomba devo dire, domani conference . Mercato al momento ripaga ampliamente. Saluti

calopre 13-09-10 18:56

LEXICON PHARMA 2,6 - 4,4 è ,secondo voi ,un obiettivo plausibile

aross 13-09-10 19:30

mi associo ai complimenti per opxa..
 
;)
Citazione:

Originalmente inviato da calopre (Messaggio 26498332)
LEXICON PHARMA 2,6 - 4,4 è ,secondo voi ,un obiettivo plausibile


calopre 14-09-10 11:58

XenoPort surges on drug update. Synta expands trial. Otix Global acquired, shares double. After the bell: Ironwood soars, Icagen falls. PDF | Print | E-mail
Written by BioMedReports.com Staff
Monday, 13 September 2010 17:51
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Below are some of the newsmakers in the healthcare sector on Monday, September 13, 2010.
After the bell Monday, Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C). Analyses of the data indicate clinically meaningful and statistically significant improvement was achieved for linaclotide-treated patients compared to placebo-treated patients for all four primary efficacy endpoints, which included two composite responder endpoints encompassing abdominal pain and complete spontaneous bowel movements (CSBMs), as well as individual responder endpoints for abdominal pain and CSBMs. Significant improvement was also achieved for linaclotide-treated patients compared to placebo-treated patients for all pre-specified secondary endpoints, which are measures of abdominal pain, abdominal discomfort, bloating, and bowel symptoms. The safety results were consistent with those observed in previous linaclotide trials, with diarrhea being the most common adverse event in linaclotide-treated patients. A second Phase 3 trial of linaclotide in IBS-C is ongoing with top-line results expected in Q4 2010.
In the after hours market, shares of Ironwood surged more than 24%, trading up $2.25 to $12.15. Shares of Forest Labs rose nearly 5%.

Icagen, Inc. (Nasdaq:ICGN) today after the bell announced that due to the occurrence of a serious adverse event in the photosensitivity study of ICA-105665, the Company has suspended further enrollment in the study. The serious adverse event occurred in the 600mg patient cohort following completion of the 500mg patient cohort. The Company will be discussing the status of the study with its clinical advisors and with the FDA. Additionally, the Company has completed the conduct of the multiple ascending dose study in healthy volunteers at daily doses of 500mg and 600mg for a period of seven days. There have been no serious adverse events noted, pending a final review of laboratory data. Analyses of the complete data set from both studies are ongoing.

Shares of Icagen fell more than 17% in extended trading Monday.

Earlier Monday:

XenoPort, Inc. (Nasdaq:XNPT) announced today that it plans to move arbaclofen placarbil (AP), also known as XP19986, into Phase 3 development as a potential treatment of spasticity in multiple sclerosis (MS) patients. Following discussions with the U.S. Food and Drug Administration (FDA), XenoPort intends to conduct a single placebo-controlled Phase 3 efficacy clinical trial and an open-label, long-term, safety study of AP in patients with MS. Favorable results from these studies could lead to the filing of a new drug application (NDA) with the FDA under Section 505(b)(2) seeking approval of AP for the treatment of spasticity.

Ronald W. Barrett, chief executive officer of XenoPort, stated, "In our previous Phase 2 clinical trial in spinal cord injury patients with spasticity, AP was well tolerated and demonstrated dose-dependent improvement in muscle tone that was maintained throughout the twelve-hour dosing interval. We hope to demonstrate similar results in our Phase 3 trial of AP in MS patients with spasticity."

Randall Schapiro, M.D., Clinical Professor of Neurology at the University of Minnesota and President of the Schapiro Multiple Sclerosis Advisory Group, stated, "Available treatments do not fully address the needs of MS patients with spasticity. Baclofen is often used in these patients, but its short duration of action and central nervous system side effects can result in sub-optimal therapy. A new oral medicine that could maintain efficacy with limited adverse events would be a welcome addition to the spasticity treatment armamentarium."

XenoPort intends to initiate this Phase 3 clinical program in the first half of 2011.

Shares of XenoPort soared on the news, jumping $1.35 or nearly 22% to $7.55.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it was expanding its Phase 2 clinical trial of STA-9090 in patients with Stage IIIB and Stage IV non-small cell lung cancer (NSCLC) from up to 69 patients to up to 146 patients based on encouraging activity observed in the first stage of the two stage clinical trial. STA-9090 is a potent, second-generation, small-molecule Hsp90 inhibitor, with a chemical structure unrelated to the first-generation, ansamycin family of Hsp90 inhibitors.

"This NSCLC trial is enrolling patients into cohorts defined by the mutational status of key genes in order to identify cancer types especially responsive to STA-9090," said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. "In the first stage of this trial we have seen exactly that; patients with EGFR and KRAS wild type, representing over 70% of all NSCLC, have shown a high disease control rate, over 70%. This early signal, combined with the objective responses seen following treatment with STA-9090, is very encouraging, particularly as the patients have been heavily pretreated and are refractory to many standard of care drugs.

On 3 times the daily average volume, shares of Synta surged more than 17% or 55 cents, closing the day near the HOD at $3.72.

Otix Global, Inc. (Otix) (Nasdaq:OTIX), a leading provider of hearing care services and solutions and the parent company of Sonic Innovations, Inc. (Sonic) and HearingLife, today announced that it has entered into a definitive merger agreement with William Demant Holding A/S (WDH), the parent company of hearing aid companies, Oticon and Bernafon. Under the merger agreement WDH will pay $8.60 for each outstanding share of Otix common stock.

"In a short period of time, Otix Global has grown from an innovative start-up company to a leading manufacturer and distributor of superior hearing solutions under its Sonic and HearingLife brands. Our product lines have garnered industry attention and awards and are representative of the innovative technology for which Otix is known," said Otix Chairman and CEO Sam Westover. "The merger with William Demant will provide the research and development, marketing and sales support and resources necessary to further expand Sonic and HearingLife's presence in the hearing healthcare industry."

The proposed transaction represents a 112% and 125% premium to Otix's 5-day and 30-day average stock prices, respectively, as of the last trading day before the merger announcement. The boards of directors of Otix and WDH have given their approvals to the transaction, which is subject to German and Australian merger control regulations, and other customary closing conditions. The agreement will require the approval of Otix's shareholders. It is anticipated that the merger will be completed between mid-November and the end of 2010.

Shares of Otix doubled down on the news, rising $4.30 or 106% to $8.34.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC), (Nasdaq:CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

"The SPA agreement with FDA represents an important milestone for Cyclacel and provides a clear registration pathway for sapacitabine," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "If it reaches the market, sapacitabine would be the first orally-administered drug to be offered to this patient population with the potential to serve as induction, consolidation and maintenance treatment of this life-threatening disease. In addition to progressing to Phase 3 in AML, we look forward to reporting sapacitabine Phase 2 data in myelodysplastic syndromes (MDS) and non-small cell lung cancer (NSCLC)."

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the initiation of the pivotal Phase 2 clinical trial of its investigational pan-BCR-ABL inhibitor, ponatinib (previously known as AP24534), in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL). The PACE (Ponatinib Ph+ ALL and CML Evaluation) trial is designed to provide definitive clinical data for regulatory approval of ponatinib in this setting. Ponatinib has been granted orphan drug status in both the United States and Europe for the treatment of CML and Ph+ ALL.

CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received approval from the North Mississippi Health Services Institutional Review Board ("IRB") to begin enrollment of subjects for a Phase III clinical trial of Multikine, the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. An IRB is a group formally designated by an institution to review and monitor research involving human subjects and to ensure protection of their rights and welfare. On heavy volume shares of CEL-SCI rose more than 10%.

Laboratory Corporation of America Holdings (NYSE: LH), today announced that it has entered into a definitive agreement under which LabCorp will acquire Genzyme Genetics, a business unit of Genzyme Corp. (NASDAQ: GENZ), in an all cash transaction valued at $925 million. Net of expected income tax benefits, less acquisition-related expenses, the acquisition has a net cash cost to LabCorp of approximately $795 million.

Marina Biotech, Inc. (NASDAQ:MRNA), a leading RNA-based drug discovery and development company, today reported results from in vivo studies in rodent cancer models focused on effective delivery of a microRNA (miRNA) mimetic using Marina Biotech's proprietary Di-Alkylated Amino Acid (DiLA2) delivery system. Organ and tumor distribution studies demonstrated up to a 100-fold increase in miRNA copies per tumor cell as compared to baseline levels. Similar increases in the miRNA levels were noted in liver, lung, and heart after systemic administration of the mimetic formulated in DiLA2-based liposomes. Moreover, delivery of the miRNA mimetic in DiLA2 liposomes demonstrated approximately 60% knockdown of mRNA for two genes whose down-regulation is the intended target of the miRNA mimetic. "These data highlight the significant breadth in the potential uses of Marina Biotech's DiLA2 delivery system for RNA-based therapeutics," said J. Michael French, President and CEO of Marina Biotech.

Positron Corporation (OTCBB:POSC), a molecular imaging company specializing in Nuclear Cardiology and a leader in Cardiac PET, announced today the grand opening of its Clinical and Technical Cardiovascular PET Training Institute in Niagara Falls, NY.

The training center will educate physicians, technologists, nurses and administrators on the use and benefits of cardiac PET imaging in the daily operations of their facility. The training will be done in a partnership with the Heart Center of Niagara where Positron's medical director, Michael E. Merhige, M.D., F.A.C.C currently operates a Coronary Artery Disease Reversal and Prevention Center guided by Positron PET imaging technologies.

Pro-Pharmaceuticals, Inc. (OTC: PRWP), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that it has engaged the Numoda Corporation, a leading information, process and logistics management company, to oversee the Phase III clinical trial of DAVANAT and 5-FU compared with the standard of care in the treatment of patients with advanced, metastatic colorectal cancer.

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the appointment of Peter Brandt and Richard Kivel to the company’s board of directors.

RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic and other biologic implants, and Athersys Inc. (Athersys) (Nasdaq: ATHX), a leader in regenerative medicine and cell therapy research and development, announced today an agreement under which Athersys will provide RTI access to its Multipotent Adult Progenitor Cell (MAPC) technologies.

Under the agreement, RTI has licensed Athersys’ technology to isolate and preserve cells from organ and tissue donors. This will enable RTI to develop and commercialize MAPC technology-based biologic implants exclusively for certain orthopedic applications. With this license, RTI expands its capabilities for accessing the fastest growing segment of the bone graft substitutes market, while Athersys extends the application of its robust stem cell technology platform to an important segment of the orthopedic market.

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that its phase IIb clinical trial of lintuzumab (SGN-33) in older patients with acute myeloid leukemia (AML) did not meet its primary endpoint of extending overall survival. Lintuzumab is a naked monoclonal antibody that targets the CD33 antigen. As a result of the outcome of this trial, the company will discontinue its development program for lintuzumab.

"We are disappointed that lintuzumab did not demonstrate a survival benefit for older AML patients in this study. These patients have limited therapeutic alternatives due to their inability to tolerate the toxicities associated with standard high-dose chemotherapy, representing a substantial unmet medical need," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "We want to thank the patients, caregivers and investigators for their participation and commitment to the clinical evaluation of lintuzumab."

Theravance, Inc. (NASDAQ:THRX) today announced that data from the RELOVAIR program will be presented by GlaxoSmithKline (GSK) at the European Respiratory Society (ERS) Annual Congress, September 18-22, 2010 in Barcelona, Spain. RELOVAIR is being developed as a once-daily treatment combination of a long-acting beta agonist, vilanterol trifenatate (VI), and an inhaled corticosteroid, fluticasone furoate (FF) for patients with chronic obstructive pulmonary disorder (COPD) or asthma.

Vical Incorporated (Nasdaq:VICL) announced today the achievement of key efficacy, immunogenicity and safety results in a Phase 2 trial, establishing its TransVax(TM) cytomegalovirus (CMV) vaccine as the first to provide evidence of protection in immunocompromised hematopoietic cell transplant (HCT) recipients, and defining a potential pathway for further development.

Also Monday:
Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that the Company will present at the following upcoming investor conferences: Stifel Nicolaus 2010 Healthcare Conference in Boston, Massachusetts.
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) today announced it will host a conference call and webcast on Friday, September 17, 2010, at 7:00 a.m. Eastern Time (4:00 a.m. Pacific Time) following the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting.
BSD Medical Corporation (NASDAQ:BSDM) (BSD or the Company) today reported publication of an article on BSD's pioneering development of sophisticated technology o improve the delivery of heat therapy for the treatment of certain cancerous tumors.
Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, today announced it has completed its formal purchase agreement to acquire Zhuhai Oil Energy Science and Technology Ltd., an inventor and producer of unique gasoline and diesel biofuel blends, located in Guangdong Province, China. Biomagnetics intends to close on the acquisition during the CEO's trip to China this week.
BioReference Laboratories, Inc. (NASDAQ:BRLI) announced today that Marc D. Grodman M.D., President and Chief Executive Officer, is scheduled to speak at the 2 10 UBS Global Life Sciences Conference on Monday, September 20, 2010, at The Grand Hyatt Hotel located in New York, NY.
Pharming Group NV (NYSE Euronext: PHARM) today announced that it has entered into an agreement with specialty biopharmaceutical company Santarus, Inc ("Santarus") (NASDAQ: SNTS) for the commercialization of Rhucin® (recombinant human C1 inhibitor; Ruconest in Europe) in North America (the United States, Canada and Mexico) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) and other future indications.
Bristol-Myers Squibb Company (NYSE: BMY) will present at the UBS Global Life Sciences Conference Monday, September 20, 2010, in New York. Beatrice Cazala, senior vice resident, Commercial Operations, and president, Global Commercialization, Europe and
China Cord Blood Corporation ("CCBC" or "the Company") (NYSE:CO), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced its intention to conduct a share exchange with all existing warrant holders, in which the Company will offer to exchange one ordinary share for every eight warrants.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it will host an Investor Event at the NASDAQ MarketSite, Times Square, New York City at 9:00 a m. ET on Monday, September 20th, 2010.
Cyberonics, Inc. (Nasdaq:CYBX) today announced that it will present at two conferences this month.
NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced the U.S. and European launches of its Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve, designed to enhance implantation in the challenging mitral position.
Forest Laboratories, Inc. (NYSE: FRX) today announced that it has filed a response to the U.S. Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast.
Genomic Health, Inc. (Nasdaq:GHDX) today announced that members of its management team will present at the following conferences in September: Dean Schorno, senior vice president of Finance, will present at the Stifel Nicolaus Healthcare Conference 2010 on Friday, September 17 at 11:30 a.m. ET in Boston.
Incyte Corporation (Nasdaq:INCY) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).
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PDI, Inc. (Nasdaq:PDII) today announced that Nancy Lurker, the company's chief executive officer, is scheduled to present at the UBS Global Life Sciences Conference at 10:30 am ET on September 20, 2010 at The Grand Hyatt New York.
Medtronic, Inc. (NYSE: MDT) has been named a member company in the North America Dow Jones Sustainability Index (DJSI) and the FTSE4Good Index Series.
Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) will webcast its presentation at the UBS Global Life Sciences Conference on Monday, September 20, 2010. The presentation is scheduled for 10:00 a.m. Eastern Time.
Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) today announced that the Company is taking steps to strategically refocus its resources and has implemented a company-wide cost-cutting initiative.
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, has expanded its development pipeline with the addition of two novel biologic drug candidates focused on specialty markets.
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Theravance, Inc. (NASDAQ: THRX) today announced that data from the RELOVAIR program will be presented by GlaxoSmithKline (GSK) at the European Respiratory Society (ERS) Annual Congress, September 18-22, 2010 in Barcelona, Spain.

calopre 14-09-10 16:44

FDA News and Approvals



Dr. Melanie Grossman Announces NYC Availability of CoolSculpting™ Fat Reduction Procedure
NEW YORK, Sept. 14 /PRNewswire/ -- Cosmetic and laser dermatologist Dr. Melanie Grossman today announced the availability of CoolSculpting™ in her practice - a ground-breaking technology just cleared by the U.S. Food and Drug Administration for non-invasive reduction of fat. Developed by Zelti


Cell Therapeutics to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
SEATTLE, Sept. 14 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that it intends to appeal the U.S. Food and Drug Administration's (the "FDA") previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/r


FDA Accepts Sanofi Pasteur File Submission for Novel Influenza Vaccine Delivered by Intradermal Microinjection
SWIFTWATER, Pa., Sept. 13 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone® Intradermal


Roche Receives FDA Clearance for U.S. Launch of cobas 8000 Modular Analyzer Series for High-Volume Laboratory Testing

INDIANAPOLIS, Sept. 13 /PRNewswire-FirstCall/ -- Roche Diagnostics (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the cobas® 8000 modular analyzer series, a Serum Work Area solution designed for diagnostic labor





RSB Spine, LLC, Announces Additional FDA Clearance for the InterPlate® L-Ti
CLEVELAND, Sept. 13 /PRNewswire/ -- RSB Spine, LLC, today announced that the InterPlate® L-Ti has been cleared for an additional product code (KWQ). The L-Ti was previously cleared as an interbody fusion device. RSB Spine Chief Executive Officer John A. Redmond said: "We are excited abou


FDA Approves New Dosing for FASLODEX® (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women

WILMINGTON, Del., Sept. 10 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone r





CorMatrix Receives FDA IDE Approval to Begin Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM™ for Pericardial Closure
ATLANTA, Sept. 10 /PRNewswire/ -- CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that FDA has granted conditional


K-V Pharmaceutical Company Announces Completion of U.S. Food and Drug Administration Inspection and Approval to Return its First Product to Market
ST. LOUIS, Mo., Sept. 10 /PRNewswire-FirstCall/ -- K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has received notice from the U.S. Food and Drug Administration ("FDA") of the successful completion of an inspection of the Company's facilities and approval to return its firs


Bedford Laboratories™ to Begin Shipping Sumatriptan Succinate Injection, 6mg (base)/0.5 mL Packaged in Pre-Filled Syringes

BEDFORD, Ohio, Sept. 7 /PRNewswire/ --– Bedford Laboratories™ is excited to announce they have further diversified their product offerings with the addition of pre-filled syringes. FDA approval has been granted and Sumatriptan Succinate Injection, 6mg (base)/0.5 mL pre-filled syrin





FDA Approves Pediatric Use of Chemical Poisoning Treatment

SILVER SPRING, Md., Sept. 9 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride (pralidoxime chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents). The drug is approved to be adminis

si conferma interesse per elan

calopre 14-09-10 17:54

Send ARNA Crashing Down
Sep 14th, 2010 by BioRunUp


Shares of ARNA came crashing down this morning, as the FDA released the briefing documents for Thursday panel. The documents question the efficacy of ARNA’s drug, as well as bringing to light some very odd cancer data in rats. While this does not mean that ARNA will fail to receive a recommendation, it casts a negative shadow on ARNA before the panel. Shares temporarily fell into the $3 range before settling in the low $4′s, representing a nearly 40% drop from yesterday’s close.
Once again- ARNA represents why I ALWAYS sell before an FDA catalyst event. Lets briefly look at the results of the past few FDA plays:
ARNA – Negative Notes
QCOR (9/11) – DELAY
JAZZ - Negative Panel
MELA – DELAY
VVUS – Negative Panel
IPHAF - CRL (Rejection)
QCOR (6/11) – 3 Month Delay
Tags: arna

calopre 15-09-10 11:47

Cel-Sci's Multikine Back in the Spotlight PDF | Print | E-mail
Written by Vinny Cassano
Tuesday, 14 September 2010 11:39
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Finally - the long awaited news on a Multikine Phase III start date has hit the newswires. Cel-Sci Corporation (AMEX: CVM) announced earlier that the North Mississippi Health Services Institutional Review Board became the first site to approve enrollment for the Multikine trial, and it can only be assumed that this is just the start of site approvals.
The volatility of CVM's stock has certainly diminished during the course of the year - givng investors the opportunity to accumulate or reload for right around fifty cents - but an uptrend could be materializing as Monday's news sparked a significant swell in volume with over three million shares trading hands.

Now that the biggest short term question mark? A Phase III trial commencement. Cel Sci's speculative potential has yet again shown its face, and the biggest potential for the company and it's stock price lies squarely on the shoulders of Multikine. At least for the near future.



CEL-SCI CORPORATION
0.54 -0.01 (-1.83%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.Since Multikine is the first cancer immunotherapy treatment to be tested as a first line treatment, we'll finally get an idea as to how well cancer immunotherapies can work while a patient's immune system is still intact. In other words, strong; not beaten down by chemotherapy or radiation treatments. It's long been my opinion that an immunotherapeutic treatment would work better if there was an actual immune system still in place to augment.

Cancer vaccines are considered to be the wave of the future for oncology treatments, especially given the success and publicity of Dendreon's Provenge. I believe Multikine - if successful - could open the door to test other immunotherapies as a first line treatment.

Keep in mind, many cancer patients - if given the choice - would choose an immunotherapeutic treatment and its more favorable side effect profile over chemo and radiation in a heartbeat. Chemo and radiation can ravage a body and an immune system, and this becomes a quality-of-life issue for patients who are potentially living out their final days. The true extent of these statements came to light in the years leading up to the Provenge approval when patients, patient advocates and investors of Dendreon took to the streets in full force asking for the treatment to be approved.

There's a lot riding on Multikine; for the future of cancer treatment, for patients of head and neck cancer with few treatment options; and for investors who have long supported the potential of Cel Sci's products and its stock.

The trial will take place in nine countries and, according to Cel Sci, will be the largest ever conducted for this type of cancer. Since Multikine could be a game-changer, this trial is worth following whether you're an investor or not - but if you're an investor, expect gains that are Dendreon-esque if this trial is successful.

On the other hand, there is the possibility that the trial will not be successful, and Cel Sci would most likely be finished if that were to happen, barring a miraculous comeback by LEAPS for the treatment of something. I get the feeling that we haven't heard the last of LEAPS, especially if the swine flu hype is reignited this fall, but that product has to be considered second fiddle to Multikine.

It's been a long wait for long time investors, but it can finally be stated with confidence that Multikine is now a Phase III product and the risk/reward profile of the CVM stock is once again in the spotlight.

For fifty cents, this one is still worth adding, but each investor should make any BUY/SELL decision on his or her own DD.



Disclosure: Long CVM.

calopre 15-09-10 11:57

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine, manufactured at the Company's intended commercial manufacturing site. The 12-month stability data are consistent with the stability data collected at 6 and 9 months and will support the Company's submission of a New Drug Application (NDA) for Exelbine, which the Company expects to take place in the fourth quarter of this year.

American Medical Systems Holdings, Inc. (NASDAQ:AMMD), a leading provider of world-class devices and therapies for male and female pelvic health, announced today that the company is pleased with yesterday’s U.S. Court of Appeals for the Federal Circuit’s ruling that reversed a summary judgment and finding for Biolitec, Inc. The Court of Appeals found that a trial judge erred in his interpretation when he ruled last year that Biolitec didn’t infringe the patent.

Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it intends to appeal the U.S. Food and Drug Administration's (the "FDA") previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). CTI had requested accelerated approval of its NDA for this patient group for which there are no currently approved drugs. The FDA issued a Complete Response Letter to CTI related to this NDA stating, in part, that CTI should conduct an additional clinical trial prior to approval. CTI is preparing to file an appeal under the FDA's Formal Dispute Resolution process. CTI reached this decision by taking into account that CTI believes there are no approved or effective therapies for patients with relapsed or refractory aggressive NHL beyond second relapse, and that PIX 301 was the first and only randomized trial in this patient group to demonstrate significant improvement in clinically relevant endpoints including complete response rate, overall response rate, and progression free survival while being safe and effective in this indication.

.

Seattle Genetics, Inc. (Nasdaq:SGEN) and Genmab A/S (OMX:GEN) announced today that the companies have entered into an antibody-drug conjugate (ADC) research collaboration agreement. Under the agreement, Genmab has rights to utilize Seattle Genetics’ ADC technology with its HuMax-TF antibody targeting the Tissue Factor antigen, which is expressed on numerous types of solid tumors. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a co-development option for any resulting ADC products at the end of Phase I clinical development.

Also Tuesday:


Abbott (NYSE:ABT) announced today that it has been named one of the 100 Best Companies by Working Mother magazine.

AVANIR Pharmaceuticals, Inc. (Nasdaq:AVNR) today announced the electronic publication of the results of the pivotal Phase III STAR trial of its investigational drug AVP-923 (dextromethorphan/quinidine) in the Annals of Neurology.

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, announced today that the company is scheduled to present at the UBS Global Life Sciences Conference, Monday, September 20, 2010, at 10:30 a.m. Eastern Time in New York City.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that Joshua Grass, Vice President, Corporate and Business Development of BioMarin, will present a company update at the UBS Global Life Sciences Conference in New York City on Tuesday, September 21, 2010 at 3:30 p.m. ET.

Bionovo, Inc. (Nasdaq: BNVI, BNVID), a drug discovery and development company focused on unmet needs in women's health and oncology, today announced that Dr. Isaac Cohen, O.M.D, Chairman and Chief Executive Officer and Mr. Tom Chesterman, Chief Financial Officer, will be presenting at a Cambria Capital investor meeting at 4:00 p.m. MST on Thursday, September 16, 2010. The event will be held at Yorgio's Restaurant in Salt Lake City, UT.


Boston Scientific Corporation (NYSE:BSX) today announced the schedule of the Company's major events and press announcements at the Cardiovascular Research Foundation's (CRF) 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, September 21 - 25 in Washington, D.C.

Celera Corporation (NASDAQ:CRA) announced today that it will webcast its presentation at the UBS Global Life Sciences Conference on Tuesday, September 21, 2010.

Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that additional Phase I clinical trial data relating to omecamtiv mecarbil (formerly CK-1827452)was presented as a poster at the 2010 Heart Failure Society of America Annual Meeting being held September 12-15, 2010 at the San Diego Convention Center in San Diego, California.

Derma Sciences, Inc. (Nasdaq:DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that patient screening in its DSC127 Phase 2 trial in diabetic foot ulcer healing will be completed tomorrow, and that enrollment in the trial will conclude on September 30.

ERT (Nasdaq:ERES), announced today that Dr. Michael J. McKelvey, the Company's President and CEO, and Keith Schneck, the Company's Executive Vice President and CFO, are scheduled to present at UBS Global Life Sciences Conference at 11:30 AM EDT on September 20, 2010 in New York City, New York.

Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has entered into an exclusive Product Licensing & Distribution Agreement with PMG S.A. for the registration, marketing, distribution and sale of Generex Oral-lyn, the Company's proprietary buccal insulin spray product, in Chile.

Gentium S.p.A. (Nasdaq:GENT) today announced that two posters and one oral presentation on defibrotide will be presented at the 33rd World Congress of International Society of Hematology to be held at the ICC Jerusalem International Convention Center in Jerusalem, Israel, October 10-13, 2010.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, announced today that President and CEO Bruce Barclay is scheduled to present at the UBS 2010 Global Life Sciences Conference.

Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that its presentation at the Stifel Nicolaus 2010 Healthcare Conference will be webcast.

Innophos Holdings, Inc. (Nasdaq:IPHS), a leading North American specialty phosphates producer, today announced that Randy Gress, Chief Executive Officer, will address the 2010 Oppenheimer Industrials Conference in New York City on September 30, 2010 at 8:00 a.m. (Eastern Time).

Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced today that Adrian Adams, President and CEO, will present at the UBS Global Life Sciences Conference on Tuesday, September 21, 2010 at 9:00 am ET and at the JMP Securities Healthcare Conference on Monday, September 27, 2010 at 12:00 pm ET in New York City.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced it will host a conference call and webcast today at 6:00 p.m. Eastern Time to discuss the positive top-line results of its Phase 3 clinical trial of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C).

Isis Pharmaceuticals, Inc. (Nasdaq:ISIS), the leader in antisense therapeutics, today announced that management will present a company overview at UBS' Global Life Sciences Conference on Tuesday, September 21, 2010 at 4:00 p.m. ET at the Grand Hyatt New York.

Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) announced today that Bob Myers, the company's president, will present at the UBS Global Life Sciences Conference in New York on Monday, September 20, 2010 at 1:00 p.m. Eastern Time.

K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has entered into an agreement with U.S. Healthcare I, L.L.C. and U.S. Healthcare II, L.L.C. for a $20 million loan secured by assets of the Company. K-V will utilize the proceeds of the loan for working capital and general operating purposes.

Lannett Company, Inc. (NYSE AMEX: LCI) announced that today it purchased 1,270 shares of its common stock in the open market under the company's stock repurchase program.

Life Technologies Corporation (NASDAQ:LIFE) today announced that it has finalized cell line license agreements with a number of companies to provide rights to Life Technologies' proprietary CHO (Chinese hamster ovary) cell lines for the production of recombinant proteins used as therapeutic agents and vaccines.

Medivation, Inc. (Nasdaq:MDVN) today announced that David Hung, M.D., president and chief executive officer, will present at the UBS Global Life Sciences Conference on Tuesday, September 21, at 8:30 a.m. Eastern Time at the Grand Hyatt in New York.

Mediware Information Systems, Inc. (NASDAQ: MEDW) announced it is expanding the integration between Mediware's HCLL®blood transfusion management software and Epic Systems' Electronic Medical Record (EMR) software for acute care hospitals.



NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders, today announced financial results for the quarter ended June 30, 2010.

NuVasive, Inc. (NASDAQ:NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, updated guidance for 2010 today in conjunction with a meeting that it will host for analysts and investors this morning beginning at 10 a.m. ET.

Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) announced that new data from its North American and European fidaxomicin Phase 3 clinical trials in patients with Clostridium difficile infection (CDI) was presented at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.


RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) today announced that the abstract entitled Treatment of Acute Stroke With Thymosin β4 has been honored with a score in the top 10 percent of all abstracts presented at the American Heart Association’s specialty conferences during the year, and therefore has been selected for re-presentation as a poster at the AHA’s Scientific Sessions on November 15.

Safeway Inc. (NYSE:SWY) announced today that all Safeway pharmacies in the United States can now administer a new high-dose flu vaccine called Fluzone High-Dose which has been approved by the FDA for use in people 65 years of age and older.



Skystar Bio-Pharmaceutical Company (NASDAQ:SKBI) a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, announces that Mr. Weibing Lu, Skystar chairman and chief executive officer, and R. Scott Cramer, Director and U.S. Representative, will preside over the NASDAQ stock market closing bell ceremony today at the NASDAQ MarketSite in Times Square, New York.

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers, today announced that Daniel Swisher, Chief Executive Officer of Sunesis, will be presenting at the UBS Global Life Sciences Conference on Tuesday, September 21, 2010 at 1:30 P.M. Eastern Time at the Grand Hyatt New York.

Tengion, Inc. (Nasdaq:TNGN), a leader in regenerative medicine, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion, will present at the upcoming UBS Global Life Sciences Conference on Monday, September 20, 2010, at 8:30am EDT.

Sample Preparation Plate, representing a novel approach for the removal of phospholipids from biological samples.


Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced that Mark Corrigan, President and CEO is scheduled to preside over the NASDAQ closing bell ceremony on Friday, September 17, 2010 at 4:00 p.m. to celebrate the Company's recent name and ticker symbol change.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

calopre 15-09-10 17:08

Intellect Neurosciences CEO Predicts Future of Alzheimer’s Disease-Modifying Drugs PDF | Print | E-mail
Written by Barbie Ann Marie Dunn, United Press Networks
Wednesday, 15 September 2010 06:01
2
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Dr. Daniel Chain, Chairman and CEO of development-stage biopharmaceutical company Intellect Neurosciences Inc. and inventor of an antibody-based technology platform for the treatment of Alzheimer’s disease, predicts despite recent Big Pharma failures (New York Times: Lilly Halts Alzheimer’s Drug Trial), we are less than five years from an Alzheimer’s drug that treats the disease, not just the symptoms.

“I am confident that the first disease-modifying drugs will be on the market within the next five years with follow-on generation improved drugs with increased safety and efficacy also on the way. My confidence is based on the progress that has been made over two decades of intensive research resulting in our current understanding of the underlying root cause of Alzheimer’s disease and the preliminary, but so far encouraging, data starting to emerge from clinical trials regarding products currently in advanced development,” said Chain.

Chain is the inventor and patent holder for the ANTISENILIN® technology platform already licensed by Intellect to several major pharmaceutical companies with antibody products in late stage clinical trials. Notable examples of antibodies that possess the key features of the ANTISENILIN® approach are Ponezumab being developed by Pfizer and Bapineuzumab being co-developed by Pfizer and Johnson & Johnson, currently being tested in Alzheimer's Phase II and Phase III clinical trials, respectively.Chain envisions his team at Intellect will play a key role in developing an optimized product with improved efficacy and safety features compared to first generation antibodies for Alzheimer’s.

In addition, Chain predicts Intellect will develop a prophylactic vaccine, the holy grail of Alzheimer’s research, with the potential to delay or prevent onset of the disease. In contrast to most other small biopharmaceutical companies that are focused on single technologies, Chain’s approach is to develop a diversified technology and product pipeline which includes a number of products based on different mechanisms giving the company the strongest chance of success.
Indeed, the company’s most advanced internally developed product – a copper-binding molecule which was so far tested in Phase I trials –works by a completely different mechanism of action than the antibody approach.

Drug development takes more than a dozen years to get to FDA approval and requires at minimum a billion dollars of investment. Most drugs fail due to safety issues or lack of efficacy, which usually manifest in large-scale, late-stage trials.

When a major drug trial fails, everyone questions the hypothesis, in this case the amyloid approach, but Chain says it’s not a mistake in amyloid theory that contributed to the most recent setback, but the safety features of the drug in the trial, which made the patients worse and in some cases even increased the risk of skin cancer.

In an exclusive to BioMedReports.com after the Lilly announcement, Chain said, “An understanding of the background and the drug’s mechanism of action affecting the function of a physiologically important protein may be helpful to avoid casting the baby out with the bathwater.”

calopre 15-09-10 17:46

Product Pipeline
Myrexis' Development Pipeline

Myrexis, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel drugs for the treatment of cancer. Our pipeline includes clinical and pre-clinical product candidates with distinct mechanisms of action and novel chemical structures that have the potential to be first-in-class and/or best-in-class therapeutics.

Myrexis maintains a fully-integrated drug discovery operation designed to identify modulators of novel targets for clinical development.




Program Preclinical Phase 1 Phase 2 Phase3
Azixa™
GBM

Azixa™
GBM


MPC-3100
Hsp90

MPC-9528
CMI

MPI-485520
OAI

MPI-487109
Hsp90 follow-on


MPI-443803
Brian Cancer

calopre 16-09-10 11:38

in arrivo l'influenza,
chi è più avanti con i vaccini e chi sarà la sorpresa?
o useranno i vaccini novartis ancora una volta.
tornano in ballo vical cvm gnbt e altri
voi che ne pensate

doroty 16-09-10 13:14

Buongiorno
ARNA e ALKS sospese- oggi si riunisce la commissione consultiva
http://www.nasdaqtrader.com/Trader.aspx?id=TradeHalts

ales86 16-09-10 13:26

Citazione:

Originalmente inviato da doroty (Messaggio 26530035)
Buongiorno
ARNA e ALKS sospese- oggi si riunisce la commissione consultiva

http://www.thestreet.com/story/10862...ted-today.html :

Alkermes, Inc. (NASDAQ: ALKS) today announced that NASDAQ has halted trading of the company’s common stock this morning. The Psychopharmacologic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) meets today to review the company’s supplemental New Drug Application (sNDA) for VIVITROL ® (naltrexone for extended-release injectable suspension) for opioid dependence. The sNDA for VIVITROL for the treatment of opioid dependence was submitted in April 2010. In May the FDA designated the sNDA a priority review, a designation that accelerates the FDA’s target review timeline from ten to six months for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. With priority review, the Prescription Drug User Fee Act (PDUFA) date for the FDA’s decision regarding approval of the VIVITROL sNDA for opioid dependence is October 12, 2010.

calopre 16-09-10 21:52

Clinical Programs
Pre-Clinical Development
Portfolio
Rexahn’s portfolio presents unique compounds for a wide variety of conditions from cancer to brain disorders. This highly diversified pipeline promises to bring an improved standard of care in multiple healthcare sectors.

Rexahn’s robust pipeline of clinical-stage and pre-clinical compounds being internally developed or co-developed with a partner:


R&D Preclinical Phase I Phase II Phase III

Serdaxin®
Depression

Serdaxin® Parkinson’s Disease

Zoraxel™ Erectile Dysfunction

Archexin® Pancreatic Cancer

RX-1792 Oncology

RX-5902 Oncology

RX-3117 Oncology

RX-8243 Oncology

RX-0201-N Oncology

RX-0047-N Oncology

non è interessante?

calopre 16-09-10 22:06

ARNA Fails to Gain Panel Approval / ALKS Wins Panel Approval
Sep 16th, 2010 by BioRunUp

ARNA Final Vote: 9 No / 5 Yes

Rumors are floating that ARNA will fall below $1 when trading resumes.

ALKS Final Vote: 11 Yes / 2 No


Posted in Breakout | 2 Comments »

9/16/10 – The Day of Reckoning for ARNA and ALKS
Sep 15th, 2010 by BioRunUp

Today is the day of reckoning for both ARNA and ALKS. A reminder on the process:

Day of the Panel

The day of the panel (9/16) trading of the stock is halted. At this point, if you hold a position, you are locked in. The panel is a public meeting and it is available for webcast for $140 through various services. Adam Feuerstein from TheStreet.com will be live blogging the ARNA panel, and we will be sending an email alert out the instant the panel votes have been announced. Make sure you sign up for the email update list below, if you have not already done so.

Trading usually will resume in after hours and will be volatile. If there is not time for after hours, it will open as usual the following morning. Usually the company will hold a conference call the morning after the panel decision to answer any questions.


Posted in Breakout | 11 Comments »

calopre 16-09-10 22:17

FDA News and Approvals



Solta Medical Announces FDA 510(k) Clearance of Fraxel re:store Dual Laser System for the Treatment of Actinic Keratosis
HAYWARD, Calif., Sept. 16 /PRNewswire/ -- Solta Medical, Inc. (Nasdaq: SLTM), the pioneer in fractional resurfacing and non-invasive skin tightening and a market leader in aesthetic skin treatments, today announced it has received FDA 510(k) clearance of its Fraxel re:store®Dual for the treatme


FDA approves devices for left bundle branch block patients
The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients. The new use is for patients with an abnormality known as left bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. The three devices, all manufactured by Boston Scientific Corp., are intended to treat patients with left bundle branch block who have either mild heart failure or heart failure with no apparent symptoms. (dt)


Abbott Statement on the FDA Advisory Committee Recommendation on Sibutramine
ABBOTT PARK, Ill., Sept. 15 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT (Sibutramine Cardiovascular OUTcome Trial) and the weight loss medication sibutramine (sold as Meridia&


The Karmanos Cancer Center One of the First in Michigan to Use PROVENGE, the New FDA-Approved Drug for Advanced Prostate Cancer

DETROIT, Sept. 15 /PRNewswire-USNewswire/ -- The Barbara Ann Karmanos Cancer Center in Detroit was recently selected to be one of 50 sites in the United States to offer the new U.S. Food and Drug Administration (FDA)-approved drug PROVENGE® (sipuleucel-T) to treat patients with advanced metasta





Forest Pharmaceuticals agrees to guilty plea for violating FDA laws
The U.S. Food and Drug Administration (FDA), working in close coordination with the U.S. Department of Justice (USDOJ), today announced that Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.


FDA issues new dosing guide for children using Valcyte
The U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant. The update is intended to prevent drug overdosing of children with low body weight, low body surface area, and very low serum creatinine. The revised dosing instructions now appear in the product’s label.

ales86 16-09-10 23:48

Citazione:

Originalmente inviato da calopre (Messaggio 26537625)
ARNA Fails to Gain Panel Approval / ALKS Wins Panel Approval
Sep 16th, 2010 by BioRunUp

ARNA Final Vote: 9 No / 5 Yes

Rumors are floating that ARNA will fall below $1 when trading resumes.

ALKS Final Vote: 11 Yes / 2 No


Posted in Breakout | 2 Comments »

9/16/10 – The Day of Reckoning for ARNA and ALKS
Sep 15th, 2010 by BioRunUp

Today is the day of reckoning for both ARNA and ALKS. A reminder on the process:

Day of the Panel

The day of the panel (9/16) trading of the stock is halted. At this point, if you hold a position, you are locked in. The panel is a public meeting and it is available for webcast for $140 through various services. Adam Feuerstein from TheStreet.com will be live blogging the ARNA panel, and we will be sending an email alert out the instant the panel votes have been announced. Make sure you sign up for the email update list below, if you have not already done so.

Trading usually will resume in after hours and will be volatile. If there is not time for after hours, it will open as usual the following morning. Usually the company will hold a conference call the morning after the panel decision to answer any questions.


Posted in Breakout | 11 Comments »

OK!

http://www.reuters.com/article/idUSN1625620420100916

* FDA advisers vote 12-1 to back new use for Vivitrol

* Panelists say new formulation appears safe, effective

* Some see sales reaching $125 mln with wider use

* Final FDA decision expected by Oct. 12

By Susan Heavey

WASHINGTON, Sept 16 (Reuters) - Alkermes Inc's (ALKS.O) Vivitrol drug to treat alcoholics should be approved to help treat people addicted to opioid painkillers, a U.S. Food and Drug Administration advisory panel said on Thursday.

The FDA panel of outside experts, in a 12-1 vote, said the drug could help a desperate group of people with few options to help kick their dangerous addictions.

Sales could reach $125 million by 2015 if the drug wins wider approval, according to Leerink Swann Research Analyst Steve Yoo. Vivitrol's net sales were $20.2 million for fiscal 2010, compared with $16.9 million in 2009 for Alkermes and its then-partner Cephalon Inc (CEPH.O), according to Alkermes.

"We do need tools," said panelist Betty Tai, director of the Center for Clinical Trials Network at the National Institute on Drug Abuse at the National Institutes of Health. "We do need options, and we have so few options for addiction."

Vivitrol was approved for alcohol addicts in 2006, but the biotechnology company is seeking to expand its approval. Formal FDA clearance allows the company to legally market the new use and can also impact insurance reimbursement.

FDA officials will consider the panel's recommendation as they make their final approval decision, expected by Oct. 12. (Reporting by Susan Heavey; Editing by Bernard Orr)

calopre 17-09-10 10:35

Arena Pharmaceuticals and Orexigen Therapeutics swing on weight-loss pill decision PDF | Print | E-mail
Written by Mary Davila
Thursday, 16 September 2010 20:01
2
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Below is a look at some of the headlines for companies that made news in the healthcare sector on September 16, 2010.

Shares of Arena Pharmaceuticals, Inc.(NASDAQ:ARNA) suffered a major setback on Thursday when U.S. advisers rejected its proposed weight-loss pill amid concerns that tumors in rats might indicate a risk of cancer in humans.Lorcaserin, Arena's most advanced drug candidate, is the second diet drug to stumble in a race among three small companies to launch the first new prescription diet drug in a decade.Arena shares fell nearly 40 percent in after-hours trading Thursday to $2.28. The shares had been halted in regular trading pending results of the advisory meeting.

Orexigen Therapeutics (NASDAQ:OREX) jumped 40% late in the day, but then fell after hours following a news item posted by Matthew Herper of Forbes who wrote: "This should be obvious, but based on the sudden 40% jump in share price of Orexigen, the tiny obesity drug developer, apparently not: There is no way that Orexigen is more valuable following a key vote against a drug being developed by its competitor, Arena Pharmaceuticals." The biopharmaceutical company focused on the treatment of obesity, today announced that the Company will be speaking at the UBS Global Life Sciences Conference in a few days.

Also Thursday:
Abbott (NYSE:ABT) today announced the company's schedule of key data presentations at the Cardiovascular Research Foundation's 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., to be held Sept. 21 – 25.

Akorn, Inc. (NASDAQ:AKRX) a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Erythromycin Ophthalmic Ointment USP 1 g as a supplement to the Company’s already approved Abbreviated New Drug Application (ANDA) for Erythromycin Ophthalmic Ointment USP 3.5 g.

Alkermes, Inc. (NASDAQ: ALKS) today announced that NASDAQ has halted trading of the company’s common stock this morning. The Psychopharmacologic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) meets today to review the company’s supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

Amarin Corporation plc (Nasdaq:AMRN) today announced that John Thero, Chief Financial Officer, is scheduled to present on Amarin's behalf at the Global UBS Life Sciences Conference on Wednesday, September 22, 2010 at 12:30 pm. This conference will be held at the Grand Hyatt New York in New York City.

Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in a population of overweight and obese individuals to allow marketing approval.

Assured Pharmacy (Pink Sheets:APHY), a leading specialty pharmacy group providing prescription medications to more than 3,000 sufferers of chronic pain announced that total sales on a same store basis for the month of August 2010 were $1,423,819 which equates to $64,719 per business day.

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced positive top-line results from its randomized, double-blind, multi-center, placebo-controlled Phase 2 study designed to evaluate the urate-lowering activity and safety of several doses of BCX4208 alone and in combination with selected doses of allopurinol administered once-daily.

Bionovo, Inc. (Nasdaq: BNVI, BNVID), a drug discovery and development company focused on unmet needs in women's health and oncology, today announced that it has received notification from the NASDAQ Listing Qualifications department that it has regained compliance with the $1.00 minimum bid price requirement for continued listing set forth in Listing Rule 5450(a)(2), as its common stock has achieved a closing bid-price of $1.00 or more for 10 consecutive business days.

BioTime, Inc. (NYSE Amex: BTIM) announced that Chief Executive Officer Michael West, Ph.D. will deliver a keynote presentation this week at the Sixth Chinese Congress in Regenerative Medicine and Stem Cell Therapy being held September 16-19, 2010 in Suzhou, P.R. China.

Corcept Therapeutics Incorporated ("Corcept") (NASDAQ:CORT), a pharmaceutical company engaged in the discovery and development of drugs for the treatment of severe metabolic and psychiatric disorders, today announced that Steven Lo has joined the company as Vice President, Commercial Operations.

Cord Blood America, Inc.(OTC Bulletin Board:CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells, a biological insurance policy, to families nationwide and internationally, said today that Matthew Schissler, its co-founder and CEO, was interviewed by analyst Francis Gaskins on the Company's current accomplishments and future business strategies.

Cytori Therapeutics, Inc. (NASDAQ:CYTX) has extended the term and modified the focus of its current distribution agreement with GE Healthcare. GE Healthcare’s sales rights allow its sales force to sell Cytori technology in the research markets in select European markets and the US.

Dynavax Technologies Corporation (NASDAQ:DVAX) announced today that its Chief Business Officer, Michael Ostrach, plans to make a formal presentation at UBS Global Life Sciences Conference 2010 on Monday, September 20, 2010 at 2:00 pm Eastern Time (11:00 am Pacific Time) at the Grand Hyatt Hotel in New York City, NY.

Generex Biotechnology Corporation (NasdaqCM: GNBT) today announced presentations in respect of the technologies and development products of its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).

Grupo International Inc. (PINKSHEETS: HIVV), President Ramon Richard announced that the Company will expand its newest "RiMart" Store.

GTx, Inc. (NASDAQ: GTXI), announced today that management will present a company overview on September 22 at the UBS Global Life Sciences Conference in New York City.

Health Grades, Inc. (Nasdaq:HGRD) ("HealthGrades") today announced the extension of the offer period for the previously announced tender offer for all of the outstanding shares of common stock of HealthGrades for $8.20 per share in cash, without interest and less any applicable withholding taxes, until 9:00 AM, New York City time, on Thursday, October 7, 2010.

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies (the “Company”), today announced that it has contracted with the clinical research organization (CRO) Averion International Corp. to conduct its planned Phase II study of ICT-107, the Company’s lead cancer-vaccine candidate for the treatment of glioblastoma multiforme (GBM).

ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA), today announced that it has initiated a Phase 3 clinical program of ISTA's proprietary formulation of REMURA™ (bromfenac ophthalmic solution for dry eye) for alleviating the signs and symptoms of dry eye disease.

Johnson & Johnson (NYSE:JNJ) said today that Colleen Goggins, 56, Worldwide Chairman, Consumer Group, has announced her retirement from the Company effective March 1, 2011, after a successful and distinguished career spanning almost 30 years.

Kraig Biocraft Laboratories, Inc. (OTCBB:KBLB) announced that a research report on the Company has been issued by Emerging Growth Research.

LifeVantage Corporation (OTC Bulletin Board:LFVN), the maker of Protandim®, a patented dietary supplement that has been shown in a clinical trial to reduce the age-dependent increase in markers of oxidative stress, announced today fiscal year 2010 financial and operating results.

Medizone International, Inc. (OTCBB:MZEI) announced today it has filed a US Provisional patent application covering the use of AsepticSure™ for disinfecting sports equipment and training facilities.

MMRGlobal, Inc. (OTCBB:MMRF) (www.mmrprovideos.com) announced today that it has installed its web-based MMRPro professional solution for digitizing medical records (www.mmrpro.com) in the Spalding Surgical Center of Beverly Hills.

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today announced the pricing of an underwritten public offering of 6,880,000 shares of its common stock at a price to the public of $6.00 per share, for an aggregate public offering price of $41.3 million.

Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced that it will present at the UBS Global Life Sciences Conference on Wednesday, September 22, 2010 at 3:00 p.m. Eastern Time (12:00 p.m. Pacific Time).

PacificHealth Laboratories, Inc. (OTCBB: PHLI), a leading sports nutrition company, announced today new portable single serve packs for their 4:1 ratio endurance drinks ACCELERADE™, ACCELERADE HYDRO™, and ENDUROX® R4® are now available.

Pall Corporation(NYSE:PLL) (Port Washington, New York), a leading global filtration solutions provider, reported strong overall results for fourth-quarter and full-year 2010, based on a strong year-round performance in the company's life sciences businesses and significant improvement in the Microelectronics segment.

PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) announced today that it has completed the retirement of the remaining $54.3 million in aggregate principal of the Company's 2.75% Convertible Subordinated Notes, due August 16, 2023 (the "2023 Notes") in exchange for 8.9 million shares of common stock and $4.2 million in cash.

Protectus Medical Devices, Inc. (OTCQB:PTMD) (PINKSHEETS: PTMD), a developer and marketer of innovative safety medical devices, today announced that its management team continues to work on strategic projects to support the company's business operations over the next year.

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that the Company will be attending the 18th Annual BioPartnering Europe Conference, on October 10 to 12, 2010, in London.

SMART Modular Technologies (WWH), Inc. ("SMART" or the "Company") (NASDAQ: SMOD), a leading independent manufacturer of memory modules and solid state storage products, announced today that it plans to release its financial results for the fourthquarter and fiscal year ended August 27, 2010 after the market closes on Thursday, September 30, 2010.

TetriDyn Solutions, Inc. (OTCBB:TDYS), announced today that it has delivered a proven virtualization solution targeted specifically for hospital environments like Harms Memorial Hospital in American Falls, Idaho.

VitaminSpice (OTCBB: VTMS) (German WKN: A0YE4L) (www.vitaminspice.net) yesterday filed the 2nd quarter financials to bring VTMS current with its filing and the Ewill be removed from the end of the trading symbol in the next few days.

Warner Chilcott plc (Nasdaq:WCRX) today announced that its Executive Vice President and Chief Financial Officer Paul Herendeen is scheduled to speak at the UBS Global Life Sciences Conference in New York on Tuesday, September 21st at 12:30 p.m. ET.

calopre 17-09-10 12:55

FDA advisers vote 12-1 to back new use for Vivitrol

* Panelists say new formulation appears safe, effective

* Shares up more than 51 percent in 2010

* Final FDA decision expected by Oct. 12

* CEO says sales force ready for potential expansion (Adds CEO comment, details from panel, shares halted)

By Susan Heavey

WASHINGTON, Sept 16 (Reuters) - Alkermes Inc's (ALKS.O) Vivitrol drug to treat alcoholics should be approved to help treat people addicted to opioid painkillers, a U.S. Food and Drug Administration advisory panel said on Thursday.

The FDA panel of outside experts, in a 12-1 vote, said the drug could help a desperate group of people with few options to help kick their dangerous addictions. It could also help the biotech, which gets revenue from just one other product.

Sales could reach $125 million by 2015 if the drug wins wider approval, according to Leerink Swann Research Analyst Steve Yoo. Vivitrol's net sales were $20.2 million for fiscal 2010, compared with $16.9 million in 2009 for Alkermes and its then-partner Cephalon Inc (CEPH.O), according to Alkermes.

"We do need tools," said panelist Betty Tai, director of the Center for Clinical Trials Network at the National Institute on Drug Abuse at the National Institutes of Health. "We do need options, and we have so few options for addiction."

The once-monthly injection was approved for alcohol addicts in 2006, but the biotechnology company is seeking to expand its approval. Formal FDA clearance allows the company to legally market the new use and can also impact insurance reimbursement.

That is key as Alkermes now loses money making the drug, which costs the Cambridge, Massachusetts company about $40 million, said Leerink's Yoo. Price and the fact that patients must get the drug at a doctor's office have so far keep many alcoholics away from using it, Yoo and others have said.

Alkermes shares have risen more than 51 percent so far this year ahead of the anticipated expansion. It is also awaiting an FDA decision on its diabetes drug Bydureon.

On Thursday, its shares were halted ahead of the meeting.

After the vote, Alkermes Chief Executive Richard Pops said the company had not disclosed potential sales for the new use should it win FDA's approval and that it was unclear how it would affect profitability for the so-far money-losing drug.

But he told Reuters that the company had a "fully functional" sales team in place already for the alcohol use and was in a "good position to launch" the wider use.

"We'll definitely walk before we run," he said. The FDA panel's support was "such an important milestone." He added that take up among opioid addicts should be better since many see doctors while most alcoholics rely on counseling and other programs.

A few panel members said they were concerned that the company's bid hinged on just one clinical trial done in Russia, but overall the panel said Vivitrol could be useful.

Vivitrol is a new formulation of naltrexone, which has been used for years in an oral form and is available as a generic. Side effects of Vivitrol can include infections, sleep problems and injection site reactions.

"We need to understand this is an adjunct," said panelist Louis Baxter, a New Jersey physician who backed wider use. "There's no one drug that can be a magic bullet."

FDA officials will consider the panel's recommendation as they make their final approval decision, expected by Oct. 12. (Reporting by Susan Heavey; Editing by Bernard Orr)

StocksRegulatory NewsGlobal Markets

calopre 17-09-10 21:19

ISTA entra in portafoglio
approvazione pharma a breve
buona valutazione titolo

calopre 18-09-10 01:52

PORTAFOGLIO TITOLI
I VINCENTI
SNVT KV/A OPXA
I PERDENTI
ARNA
BUONE PROPABILITA' ISTA ALXA BIOD ALKERMES cvm myrx jazz teva sorpresa rnn LEXICON PHARMA
che ne dite? ragionateci sopra e riproponetevi

calopre 19-09-10 00:49

fate attenzione con arna, dopo la bocciatura ci saranno almeno tre anni di privazioni
HOME CONTACT US SITE MAP

ABOUT US PRODUCT CANDIDATES RESEARCH PROGRAMS GPCR TECHNOLOGY INVESTORS CAREERS



PIPELINE
LORCASERIN
LORCASERIN BLOOM RESULTS
LORCASERIN BLOSSOM RESULTS
APD791
APD916
APD811
APD597
Product Candidates

Lorcaserin
Weight Management
APD791*
Arterial Thrombosis
APD916
Narcolepsy and
Cataplexy
APD811
Pulmonary Arterial
Hypertension
APD597
Type 2 Diabetes

*Not currently in active development.


pipeline in fase 2

calopre 19-09-10 18:17

Sarraf Gentile LLP Investigates Arena Pharmaceuticals, Inc.
NEW YORK, Sept. 17, 2010 (GLOBE NEWSWIRE) -- Sarraf Gentile LLP announces that it is investigating Arena Pharmaceuticals, Inc. ("Arena" or the "Company) (Nasdaq:ARNA) in connection with the rejection of the Company's weight loss pill lorcaserin by a panel of Food and Drug Administration experts.

According to the Associated Press, an FDA panel of experts voted 9-5 on Thursday, September 16, 2010, against the approval of lorcaserin saying some unresolved safety questions outweighed its benefits and raising concerns about tumors seen in rats in early-stage testing. The Company's share fell 45% percent, or $1.67, to $2.08 in trading Friday before the market opened, according to the Associated Press.

If you purchased or own Arena stock and want to discuss your legal rights, at no cost and without obligation, please contact Joseph Gentile at Sarraf Gentile LLP (telephone: 212-868-3610; e-mail: joseph@sarrafgentile.com).

Sarraf Gentile LLP has extensive experience litigating shareholder class actions across the United States and has recovered millions of dollars on behalf of injured shareholders.

ATTORNEY ADVERTISING. Prior results do not guarantee a similar outcome.

CONTACT: Sarraf Gentile LLP
Joseph Gentile
212.868.3610
Fax: 212.918.7967
joseph@sarrafgentile.com
www.sarrafgentile.com
116 John Street, Suite 2310
New York, NY 10038

calopre 19-09-10 18:24

ISTA is developing a once-daily version of Xibrom, or XiDay, for the treatment of ocular inflammation and pain following cataract surgery. In August 2009, we announced positive preliminary Phase III results from our XiDay Phase III confirmatory clinical study. XiDay achieved statistical significance in the study’s primary endpoint, the absence of ocular inflammation 15 days following cataract surgery, and the secondary efficacy endpoint, the elimination of ocular pain one day post surgery. In December 2009 we filed a sNDA with the FDA seeking approval of the XiDay formulation for once-daily treatment for the inflammation and pain following cataract surgery. We were notified by the FDA in March 2010 about the Prescription Drug User Fee Act, or PDUFA, date of October 2010.

calopre 19-09-10 18:27

BIOD - At the end of last week BIOD began an impressive run, climbing from nearly $4 on Wednesday morning to a high of $5.14 on Friday, a gain of over 25%. It seems that money from ARNA is flowing into BIOD, which is the next ‘blockbuster’ drug up for approval. This week should be interesting for BIOD. It has two conference presentations that may attract some more attention to the company and their product ( LINK ).

EXAS – Exact Sciences continued its impressive run last week, closing Friday at $6.22, which is a nearly 60% gain from our first recommendation on 7/26 ( LINK ). Its run-up to its 10/29 conference presentation and data release has been quite impressive, and will hopefully continue.

ALXA – The next play on the FDA Catalyst Calendar is ALXA, which has a PDUFA date of 10/11/10, which is quickly approaching. We recommended buying ALXA after its dilution on 8/6 ( LINK ), and since that time the share price has climbed over 40% from $2.40 to its close on Friday at $3.43. Momentum and interest should climb as we are only 3 weeks away from an FDA decision.

ARNA – Unfortunately for those who held through the ARNA FDA Panel, last week was devastating. ARNA closed Friday at $1.99, a far cry from its run-up high of $8. Unfortunately it seems extremely likely that the FDA will issue a CRL to ARNA on its PDUFA date of 10/22/10.

calopre 19-09-10 19:30

così solo perchè lo stavo guardando
si perde il pelo ma non il vizio
ho guardato pure tutte le vicissitudini di heb
Cell Therapeutics gets OK to sell more shares
September 17, 2010 — 8:27am ET | By John Carroll


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With its options running out, the financially strapped Cell Therapeutics (CTIC) has won shareholder approval for a plan to sell another 400,000 shares to keep the biotech afloat for now. Without fresh funds, Cell Therapeutics has said that it would burn through all of its cash by the end of the year. The developer's program for the cancer drug pixantrone was harshly criticized by leading FDA staffers earlier this year for failing to recruit even half of the patients that had been planned for in a pivotal trial. However, as Xconomy notes, analysts have been quick to point out that any fresh infusion of money from sales of stock will only buy the company some additional time without improving its chances of long-term success. Its stock closed at 38 cents yesterday. Report

60 milioni di azioni 30 milioni di debito

calopre 20-09-10 10:03

Cleveland BioLabs wins huge contract from DoD, FDA reviewing safety of Actos diabetes drug PDF | Print | E-mail
Written by Mary Davila
Friday, 17 September 2010 19:15
retweet01diggdiggBelow is a look at some of the headlines for companies that made news in the healthcare sector on September 17, 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.



Glaxo kidney cancer drug shrinks thyroid tumors-study - In a small study, GlaxoSmithKline's (GSK.L) cancer drug Votrient helped shrink tumors in nearly half of patients with an advanced form of thyroid cancer, U.S. and international researchers said on Friday.

For many, the effect of the kidney cancer pill, known generically as pazopanib, lasted for more than a year, said Dr. Keith Bible of the Mayo Clinic in Rochester, Minnesota, whose findings were published in Lancet Oncology.

"These responses that occur in half of all patients are very durable. The majority, in fact two-thirds, last greater than one year," Bible said in a video interview on clinic's website.

The study was done in 37 patients with the most aggressive form of differentiated thyroid cancer. Many patients with these types of cancers can be cured with surgery and radioiodine. But 5 percent of these patients develop a rapidly progressing life-threatening disease that has few treatment options.


U.S. invests in drug to protect against radiation - Tiny biotech Cleveland BioLabs Inc (CBLI.O) has won a $45 million contract from the Department of Defense to conduct clinical trials of a drug to prevent cell damage in the event of nuclear attack. The experimental drug has already been shown to protect mice and monkeys from the damaging effects of radiation. If it works in people, it would be the first drug of its kind.

In animals, the drug has been shown to protect bone marrow and cells in the gut from being destroyed by radiation. "There are no drugs which protect humans from radiation," Michael Fonstein, the company's chief executive officer, said in a telephone interview.

The drug works by interfering with a process of programmed cell death called apoptosis -- basically a form of cell suicide. This helps the body rid itself of damaged cells,

Fonstein said interfering with this process appears to strengthen the body's ability to recover from radiation exposure. The contract with the Defense Department will give the company $14.8 million to develop the drug. It includes an option for the government to spend $30 million on the drug if it wins U.S. regulatory approval.[ID:nSGE68G0I9]. The company already is on a fast-track with the U.S. Food and Drug Administration to have its drug sped through the regulatory approval process.

Fonstein said the drug, known as CBLB502, could be approved for use in humans by mid-2012. That gives the company most of 2011 to ramp up manufacturing, complete animal and safety studies, giving the FDA another six months to complete its review. The compound is made from a salmonella protein that naturally makes cells resistant to cell suicide.


US FDA reviewing safety of Actos diabetes drug - The U.S. Food and Drug Administration said on Friday it was reviewing if Takeda Pharmaceutical Co Ltd's (4502.T) blockbuster diabetes drug Actos may be linked to bladder cancer. Actos is the Japanese drugmaker's top-selling product with sales of about $4 billion a year, but the pill is due to face generic competition after it loses U.S. patent protection in January 2011. The FDA said early data from an ongoing Takeda study showed no overall association with Actos and bladder cancer.

But an increased risk of bladder cancer was seen among patients with the longest Actos exposure and the highest cumulative doses. The preliminary results are based on 5-year data from an ongoing 10-year trial by Takeda. "At this time, FDA has not concluded that Actos increases the risk of bladder cancer," the agency said in a statement. Patients should not stop taking Actos unless told to do so by their doctor, the agency said.

Takeda said the results were early, and the company was committed to completing the 10-year study to get a better picture of bladder cancer rates.


Also Friday:


Alere Inc. (NYSE:ALR), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, announced today that it will attend the UBS Global Life Sciences Conference being held September 20 through 22, 2010 at the Grand Hyatt, Park Avenue at Grand Central, New York.

Antares Pharma, Inc. (NYSE Amex: AIS) today announced that Dario Carrara, Ph.D. has resigned from his position as Senior Vice President and Managing Director Phamaceutical Group in Muttenz, Switzerland.


Biodel Inc. (Nasdaq:BIOD) announced today the appointment of Arthur Urciuoli to the company's board of directors.



Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that it will host a conference call at 10:00 a.m. EDT on September 20 to discuss recent corporate developments.


Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that it was awarded a $45 million contract (including options), from the United States Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) to develop and stockpile CBLB502 as a medical radiation countermeasure.

CytoGenix, Inc. (Pink Sheets:CYGX) today announced that it has initiated the process of testing CytoGenix's novel liner DNA technology on ferrets, with the expectations of a positive result, furthering the development of the vaccine candidate.

Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced that a research report derived from a study using the Daxor Blood Volume Analyzer (BVA-100) was presented at the annual Heart Failure Society of America (HFSA) conference in San Diego, CA.



Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that data will be presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the European Respiratory Society (ERS) Annual Congress September 18 - 22, 2010 in Barcelona, Spain.

Medtronic, Inc. (NYSE: MDT), today announced its schedule of events for Transcatheter Cardiovascular Therapeutics (TCT) 2010, which takes place Sept. 21-25 in Washington, D.C.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that it has transferred exclusive license rights to Proximagen Limited (AIM: PRX) for a series of compound hits related to the CXCR4 target with application for a number of indications including those related to the central nervous system.

Medco Health Solutions, Inc. (NYSE:MHS) on Thursday completed its acquisition of United BioSource Corporation (UBC) in an all-cash transaction valued at approximately $730 million, creating a complementary and comprehensive research organization that extends Medco's core capabilities in data analytics and research to accelerate pharmaceutical knowledge – advancing patient safety and contributing to the body of evidence-based medicine.


Medtronic, Inc. (NYSE: MDT) announced that data from a multicenter, prospective, randomized, blinded, feasibility trial published today show promise for occipital nerve stimulation (ONS) for treating medically refractory chronic migraines and support the need for further controlled study of the treatment.

Pharmasset, Inc. (Nasdaq:VRUS) announces that management will present at the UBS Global Life Sciences Conference to be held September 20-22, 2010 at the Grand Hyatt, New York, NY.

Walgreens (NYSE: WAG) (NASDAQ: WAG), the nation’s largest retail provider of flu immunization services, and “The Dr. Oz Show,” the popular nationally-syndicated daily talk show featuring Emmy Award-winning host Dr. Mehmet Oz, are teaming up to educate the public about the importance of flu prevention.
Last Updated on Friday, 17 September 2010 20:09

calopre 20-09-10 16:05

Here now is our opportunity to reiterate some of the solid companies that we've covered recently- especially since they have treated our readers and investors well. Its important to note that some of these runners are still not done, so keep a close eye because there is definitely more to come.


Alexza Pharmaceuticals, Inc. (NASDAQ:ALXA) - This stock has been on fire since their $18M direct offering back in August, up roughly 40% since the lows in August. We began coverage on ALXA back in July and have updated subscribers about ALXA along the way. This stock still has more room to climb up until their PDUFA date for AZ-004 on October 11th, 2010. See our original report for all the details: http://biomedreports.com/articles/mo...ceuticals.html
Cleveland BioLabs, Inc.(Public, NASDAQ:CBLI) - Shares of CBLI have been climbing since we told our subscribers that the company was in line for some substantial government contracts. The stock was trading at $3.81at the time but it saw a high of $5.75 on Friday after the company was awarded a $45 million contract (including options), from the United States Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) to develop and stockpile their CBLB502 drug as a medical radiation countermeasure.

This, and the fact that the stock should be heading even higher from here, should be of no surprise to our readers after Cleveland's Biolabs' CEO & President, Michael Fonstein told BioMedReports that his company was in line for contracts with multiple components. The company will host a conference call at 10:00 a.m. EDT today to discuss recent corporate developments and a live webcast of the conference call will be available on the Cleveland BioLabs web site at cbiolabs.com.

If you want to read more about why we are so bullish regarding CBLI, we invite you to start here. We believe strongly that this company will not be trading at these new higher levels for very long: http://biomedreports.com/articles/mo...candidate.html

Chelsea Therapeutics International (NASDAQ:CHTP) - This stock went crazy on Friday, after a mention on CNBC by Peter Navarro (video linked below) sent shares to an intra-day high of $5.75!

Obviously, our readers have been in on the secret that is Chelsea Therapeutics since mid-August. Since our coverage on August 20th, subscribers are up more than 38%( or around 60% if you sold into that huge spike). We are still very bullish on the pending Phase 3 results and the hype on the Street just reaffirms our position.

Based on their recent presentation at Rodman and Renshaw, CEO Dr. Simon Pedder reiterated that results will be out at the end of September.
Read the details here: http://biomedreports.com/articles/su...ng-higher.html

Video of Peter Navarro discussing Chelsea Theraputics on CNBC: http://www.cnbc.com/id/15840232/?vid...3778896&play=1

Delcath Systems, Inc. (NASDAQ:DCTH) - Shares of Delcath have been on a roll since late-August, up more than 25% since our coverage. Remember, DCTH plans to file an NDA for their PHP system sometime in October. This event should serve as another positive catalyst and price mover.
Our report: http://biomedreports.com/articles/mo...atalysts-.html

DepoMed, Inc.(NASDAQ:DEPO) - Initial coverage began on August 4th, after DEPO avoided a potential patent lawsuit with Pfizer over the submission of DM-1796. We still believe DEPO has further to climb. Positive news about recommencing shipments of GLUMETZA 500mg product will take this higher. DEPO is up roughly 20-30% since our initial coverage, depending on entry price.

Detailed report: http://biomedreports.com/articles/mo...t-to-soar.html

Kraig Biocraft Laboratories (OTC:KBLB) has been a surprise hit of these past two weeks. We first told our subscribers about this company which is dedicated to the development of Spider silk-based material, one of the strongest and most resilient fibers known to mankind back when it was trading at $.02.
Since then, the stock has been on run which has returned substantial profits since publishing details about their new suite of patented technologies as well as news that they have successfully created transgenic silkworms. The silkworms were successfully genetically engineered with targeted spider silk DNA sequences.

Kraig Biocraft has called a press conference later this month to discuss developments in its laboratory. As a matter of fact, just this morning, the company announced that they anticipate releasing more details about that upcoming press conference later this week. Given all the recent hype, it is our belief Kraig Biocraft will make a significant announcements at that time. The stock has seen highs of $.19 and it closed at just under $.14 on Friday, but could go much higher in the weeks ahead.

Our original alert about the company can be read here: http://biomedreports.com/articles/mo...g-profits.html

Finally, when we broke the story that BMP Sunstone (NASDAQ:BJGP) had received a buy-out offer from a private company a few weeks ago, the stock was trading for just above $5. The stock is trading over $8 with even louder rumors about that pending buy-out circling the Street. Since our call, BMP Sunstone has made Smart Trend's list of top five companies in the pharmaceuticals industry as measured by relative performance.

calopre 20-09-10 18:41

vi voglio manifestare una mia impressione, dopo exas che sta dando ottime soddisfazioni e che io continuo a vendere per paura di ritracciamenti, i grafici non sono il mio forte e comunque con le bio conta più la qualità, il grafo può aiutarti a prendere un rimbalzo ma il trend di lungo è dettato dalla pipeline.in questo contesto l'unico farma con grandi potenzialità è CVM. prenderne qualche migliaio di dollari e scordarselo per un anno.

jellino 20-09-10 19:06

ciao calopre
tu come vedi il business di snss?
grazie

calopre 20-09-10 19:24

Citazione:

Originalmente inviato da jellino (Messaggio 26572080)
ciao calopre
tu come vedi il business di snss?
grazie

il farmaco è importante ma lo sviluppo ancora lungo, per quello che so non fanno altro che brevettare in tutto il mondo,comunque un rimbalzo su ASCO ci sta,poi diluizione quindi si vedrà

calopre 21-09-10 10:31

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 20, 2010.


Prestige Brands Holdings, Inc. (NYSE: PBH), a leading marketer of branded consumer products, today announced that it has entered into a definitive agreement to acquire 100% of the stock of Blacksmith Brands Holdings, Inc., for $190 million in cash. Blacksmith, a portfolio company of Charlesbank Capital Partners, owns five leading consumer over-the-counter ("OTC") brands. The transaction is subject to customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act of 1976, and is expected to close during the fourth quarter of calendar year 2010. The brands being acquired are: *Efferdent®, a powerful effervescence that cleans dentures and kills odor-causing bacteria; *Effergrip®, a zinc-free denture adhesive cream; *PediaCare®, a well-known OTC cough/cold/allergy/sinus and fever remedy for infants and children;*Luden’s®, great-tasting throat drops that relieve sore, dry and scratchy throats; and *NasalCrom®, non-drowsy allergy prevention for allergy sufferers.

Shares of Prestige surged $1.05 or 13.43% to close the day at $8.87.

Boston Scientific Corporation (NYSE:BSX) today announced the signing of a definitive merger agreement, under which Boston Scientific will acquire Asthmatx, Inc., a privately held company in Sunnyvale, California. Asthmatx designs, manufactures and markets a less-invasive, catheter-based bronchial thermoplasty procedure for the treatment of severe persistent asthma in the 6 to 8 million patients 18 years and older worldwide whose asthma is not well controlled with drugs (inhaled medications). The agreement calls for an upfront payment of $193.5 million and additional payments of up to $250 million contingent upon achievement of specified revenue-based criteria through 2019.

Asthmatx markets the Alair Bronchial Thermoplasty System, which received U.S. Food and Drug Administration (FDA) approval in April of this year. Bronchial thermoplasty is a less-invasive procedure routinely performed under conscious sedation with patients typically returning home the same day. The Alair System delivers thermal energy to the airway wall in a precisely controlled manner to reduce excessive airway smooth muscle. The procedure is designed to decrease the ability of the airways to constrict, thereby reducing the frequency and severity of asthma attacks.

Dynavax Technologies Corporation (NASDAQ:DVAX) after the bell today announced that Aspire Capital Fund, LLC, an Illinois limited liability company, has purchased 1,000,000 shares of Dynavax common stock at $2.00 per share, representing a 23% premium to the closing market price on September 17, 2010. The investment was made in connection with a $30 million At-The-Market common stock purchase agreement under which Aspire Capital has committed to purchase up to an additional $28 million of Dynavax common stock over the next 25 months.

Results from the U.S. registry of Abiomed, Inc.(NASDAQ: ABMD), AB5000 patients were recently published in the September 2010 issue of The Annals of Thoracic Surgery. The paper, "Use of the AB5000 Ventricular Assist Device in Cardiogenic Shock After Acute Myocardial Infarction (AMI)," concludes that the "results from this nationwide registry suggest that VADs can restore normal hemodynamics and support recovery of native cardiac function in the majority of survivors when conventional therapies fail."

"This is the largest reported paper on AMI cardiogenic shock patients on VAD support. It demonstrates that aggressive and early implantation of bridge to recovery VADs, such as the AB5000, can potentially improve recovery and survival outcomes of cardiogenic shock patients," said Mark Anderson, MD, Robert Wood Johnson Medical School. "Recovery should be the first option. Though VAD support for AMI cardiogenic shock patients is not yet in the clinical guidelines, this paper shows that temporary heart recovery devices have the ability to recover heart muscle and avoid heart transplantation in these critically ill patients."

Athersys, Inc. (Nasdaq:ATHX) announced today the publication of a key study in the October issue of Experimental Neurology conducted by researchers at Athersys, the University of Texas Medical School, the Michael E. DeBakey Institute for Comparative Cardiovascular Science and Biomedical Devices, and Texas A&M University. This study demonstrates that intravenous injection of MultiStem, Athersys' multipotent adult progenitor stem cell therapy product, provides neurovascular protection after traumatic brain injury (TBI) in an established preclinical model of brain injury. The publication outlines how the administration of MultiStem enabled the preservation of the "blood brain barrier", and also reduced the effects and extent of the brain injury.

Bristol-Myers Squibb Company (NYSE:BMY) and AstraZeneca (NYSE:AZN) today announced results from a randomized, double blind Phase 3 clinical study, which demonstrated that the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in glycosylated hemoglobin levels (HbA1c) in adult patients with type 2 diabetes compared to glimepiride alone. The study also demonstrated that dapagliflozin plus glimepiride achieved reductions in the secondary efficacy endpoints of change in total body weight, oral glucose tolerance test (OGTT) and fasting plasma glucose (FPG) levels from baseline at week 24 compared to placebo plus glimepiride. More people taking dapagliflozin and glimepiride were able to achieve a target HbA1c of less than 7% compared to patients taking glimepiride alone. Results from the study were presented at the 46th European Association for the Study of Diabetes (EASD) Annual Meeting.

Celera Corporation (NASDAQ:CRA) and Abbott (NYSE:ABT) today announced that they have signed an exclusive distribution agreement to market Celera's CE-marked KIF6 diagnostic test for use on Abbott’s CE-marked m2000™ instrument system. The KIF6 genotyping assay detects a genetic marker that may be used in conjunction with clinical evaluation and patient assessment for the identification of individuals at risk for coronary heart disease (CHD), and in patients for whom statin treatment is being considered.

The agreement follows the application by Celera for the CE mark in June 2010, of its real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene. This is the first of Celera’s proprietary cardiovascular genetics products to be CE marked. Under the 4-year agreement, Celera will manufacture the KIF6 test kit that Abbott will distribute in the European Union, other geographic areas that recognize the CE mark, and elsewhere worldwide, excluding the U.S. Financial details of the agreement were not disclosed.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been treated in a randomized Phase 2b study of the Company’s CDX-011 (glembatumumab vedotin) antibody drug conjugate in glycoprotein NMB (GPNMB) expressing advanced, refractory breast cancer patients. CDX-011 targets the protein GPNMB, which is over expressed in a variety of cancers including breast cancer, melanoma, and brain tumors.

"The CDX-011 antibody drug conjugate provides a targeted intervention for GPNMB expressing breast cancer, including patients with triple-negative disease" said Tom Davis, MD, Chief Medical Officer of Celldex Therapeutics, Inc. "This Phase 2b trial will target patients whose tumors express GPNMB and is anticipated to include a significant proportion of patients with difficult-to-treat triple-negative tumors. It will build upon the positive Phase 1/2 trial which demonstrated encouraging activity in both of these patient subsets."

Micromet, Inc. (NASDAQ: MITI) today announced the initiation of a phase 2 trial of the Company’s lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

This phase 2, single-arm study is intended to evaluate the efficacy, safety and tolerability of blinatumomab in 20 adult patients with B-precursor ALL who are resistant or intolerant to standard chemotherapy. Patients will receive blinatumomab daily for 28 days followed by two weeks off therapy over a six week treatment cycle, for up to five treatment cycles. Patients will receive starting doses of blinatumomab of 15 micrograms per meter squared, with dose escalation in subsequent cohorts based on tolerability. The primary endpoint of the study is objective response rate. Secondary endpoints include duration of response and overall survival.

Myrexis, Inc. (Nasdaq:MYRX), a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today announced key findings from preclinical studies of the Company's novel cancer metabolism inhibitor (CMI), MPC-9528, at the Cancer and Metabolism: Pathways to the Future Symposium in Edinburgh, Scotland. Compelling preclinical evidence demonstrates that treatment with MPC-9528 results in significant tumor growth inhibition and that the co-administration of niacin improves the therapeutic index of MPC-9528. Additional data, from a large panel of tumor cell lines and primary human tumor tissue indicate that approximately 40% of all cancers may carry a biochemical defect making them respond well to the combination of niacin and MPC-9528 treatment. A simple companion diagnostic could be used to identify patients with such tumors.


Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Ron Cohen, M.D., President & CEO, will present at the upcoming Fifth Annual JMP Securities Healthcare Conference on Monday, September 27, 2010 at 12:00 p.m. Eastern Time at The New York Palace Hotel in New York, NY.

Apricus Biosciences (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that results from a United States Pharmacopeia Preservative Efficacy Test (USP PET) qualified NexACT as an anti-microbial preservative.

Caliper Life Sciences, Inc. (Nasdaq:CALP) today announced that Kevin Hrusovsky, President and CEO of Caliper will be providing a keynote presentation this week at the MipTec conference in Basel, Switzerland.

Cardium Therapeutics (NYSE Amex:CXM) announced today that Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer will present at the 10th Annual Biotech in Europe Investor Forum to be held September 29-30, 2010 at the Radisson Blu Hotel in Zurich.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been treated in a randomized Phase 2b study of the Company's CDX-011 (glembatumumab vedotin) antibody drug conjugate in glycoprotein NMB (GPNMB) expressing advanced, refractory breast cancer patients.

China-Biotics, Inc. (Nasdaq:CHBT) the leading developer, manufacturer and distributor of probiotics products in China, today hosted its first investor day with a group of investors and analysts in Shanghai.

Cytokinetics, Incorporated (NASDAQ:CYTK) announced today that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the Fifth Annual JMP Securities Healthcare Conference on Monday, September 27th at 12:30 p.m. Eastern Daylight Time at The New York Palace Hotel in New York, New York.

Daxor Corporation, (NYSE Amex:DXR), a medical instrumentation and biotechnology company, today announced that the United States Securities and Exchange Commission ("SEC") instituted administrative proceedings pursuant to the Investment Company Act of 1940 on Friday, September 17, 2010.

Endo Pharmaceuticals (Nasdaq:ENDP) today announced the successful completion of the tender offer by its indirect wholly owned subsidiary, West Acquisition Corp., for all of the outstanding shares of common stock of Penwest Pharmaceuticals Co. (Nasdaq: PPCO).

Generex Biotechnology Corporation (Nasdaq:GNBT)the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has entered into a sales agreement with Elias Shaker & Company, a leading national full-service consumer product brokerage firm, to represent Generex's novel consumer products to national and regional retail and wholesale accounts in the USA.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 2010 UBS Global Life Sciences Conference, being held at the Grand Hyatt Hotel in New York City.

Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce the publication of "Clinical Experience Using Cortoss for Treatin Vertebral Compression Fractures with Vertebroplasty and Kyphoplasty" in the September 15, 2010 edition of Spine.

Novogen Limited (ASX:NRT) (NASDAQ: NVGN) has appointed three new Directors.

.

Sanofi-aventis (EURONEXT: SAN and NYSE:SNY) announced today results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

Sanofi-aventis (EURONEXT: SAN and NYSE:SNY) announced today the first Phase III results of the GetGoal clinical trial program assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, as monotherapy in patients with type 2 diabetes.

Vascular Solutions, Inc. (Nasdaq:VASC) and Shepherd Scientific, Inc. today announced they have entered into a distribution agreement providing for Vascular Solutionsv to distribute Shepherd Scientific's Angio Assist and Teirstein Edge products in the United States.

WuXi PharmaTech (NYSE:WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, today announced that it had been awarded a Certificate of Good Laboratory Practice (GLP) compliance from the Organization for Economic Cooperation and Development (OECD) for toxicology and mutagenicity studies conducted at the company's Suzhou facility.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that Richard Bagley, President and Chief Operating Officer, will present at the JMP Healthcare Conference on Monday, September 27, 2010 at 1:00 pm ET at the New York Palace Hotel in New York City.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

calopre 21-09-10 17:22

Citazione:

Originalmente inviato da calopre (Messaggio 26571859)
vi voglio manifestare una mia impressione, dopo exas che sta dando ottime soddisfazioni e che io continuo a vendere per paura di ritracciamenti, i grafici non sono il mio forte e comunque con le bio conta più la qualità, il grafo può aiutarti a prendere un rimbalzo ma il trend di lungo è dettato dalla pipeline.in questo contesto l'unico farma con grandi potenzialità è CVM. prenderne qualche migliaio di dollari e scordarselo per un anno.

ok oggi buona conferma, sicuramente da accumulare

calopre 21-09-10 19:50

Cel-Sci (CVM) 0.65 0.10 (18.18%)
as of Sep 21, 1:33 PM EDT


SUMMARY

BULLS

BEARS

DATA CENTRAL


STOCK CHART

SEC FILINGS

BALANCE

INCOME

CASH FLOW


Key Metrics for CVM as compared to Top CompetitorsBiotechnologyPharma & Healthcare All values TTM unless otherwise noted (*)
INCOME STATEMENT (See all)Revenue ► 122K VERY LOW
EBITDA ► 28.6M VERY HIGH
Net Income ► -14.6M AVG
Revenue Growth ► 143% AVG
Operating Margin ► 21040.6% VERY HIGH
Net Margin ► -11604.9% LOW
Revenue, Net Income, and Net MarginRevenue, Gross Profit, and Gross MarginOperating IncomeEbitIncome Before TaxesNet Income from Continuing OpsInterest vs Continuing IncomeInterest CoverageOperating ExpensesResearch & DevelopmentSG&AAmortization & Depreciation

BALANCE SHEET (most recent quarter) (See all)Debt / Equity ► 0.214 AVG
Current Ratio ► 14.8 HIGH
Quick Ratio ► 14.1 VERY HIGH
Interest Coverage Ratio ► -294 AVG
Book Value Per Share ► 0.169 AVG
Cash Per Share ► 0.149 AVG
ASSETS LIABILITIES
Cash 30.5M Current Liabilities 2.24M
Other Current Assets 2.71M Long-term Debt 0
Fixed Assets 1.30M Other Liabilities 5.19M

--------------------------------------------------------------------------------

Other Assets 7.62M Total Liabilities 7.43M

--------------------------------------------------------------------------------

Total Assets 42.1M Total Equity 34.7M

calopre 22-09-10 12:12

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the publication of a research article in Drug Development Research (71:351–357, 2010) on the neuroprotective effects of clavulanic acid, the active pharmaceutical ingredient of Serdaxin®, Rexahn’s lead CNS therapeutic currently in Phase II clinical trials.

calopre 22-09-10 13:52

votazione VVUS iin buon rialzo

Quote:

1- DR. ROGAWSKI: voted yes, teratogenicity cannot be assessed in trial, it will have to be done post market approval in large populations

2- DR. MORRATO: voted no because of the many side effects and wants to see more details on the registry and gathering more data and need for REMS

3- DR. HENDERSON: voted yes because the sponsor did satisfy the criteria for the weight loss benchmarks

4- DR. PROSCHAN: voted no because he believes the trials are too short and says �I think if we had had longer follow-up, I probably would have voted the other way. But I just don't feel comfortable with one year follow-up�.

5- Dr Burman: voted no because of the many side effects and the 1 year trial that is too short. Wants tight regulations post market registry (for birth defects) and REMS in place

6- DR. FLEGAL: voted no, wants more research (??) and control to access to the drug which is going to be used by millions

7- DR. THOMAS: voted no and wants more trials to assess cardiotoxicity in high risk groups and wants more info on suicide risk

8- DR. BERSOT: voted no for the same reasons as Thomas, plus (this is a weird bit !)� And then there are two elephants in the room that no one has mentioned today, and those are lorcaserin and the other drug that's on its way to this committee that have probably not as great efficacy in terms of weight loss, but may be better risk factor profiles. But we don't know that, and I would like to know more about all of these three different compounds before making a decision about any particular one.�

9- DR. WEIDE: voted no because he wants longer term data

10- Dr Capuzzi, said voted yes, but changed in no, no reasons for either decision

11- Dr Kaul voted yes, but with conditions that only low and medium doses are approved and wants the sponsor to conduct a pharmacodinamic study �focusing specifically on commonly used medications, including cardiovascular and over-the-counter medications� ( wow, all of them ???) He wants the FDA decision to be a conditional approval that can be withdrawn if the sponsor does not satisfy the above mentioned conditions

12- DR. HENDRICKS: voted yes, because Qnexza meets the efficacy

13- MS. COFFIN: voted yes, believes the side effects are reasonable and the single drugs are already on the market and doctors keep prescribing the off label anyway

14- DR. CRAGAN: voted no, because of teratogenicity issues

15- DR. HECKBERT: voted no, because of the adverse effects including sucidality, cardiotoxicity and teratogenicity

16- DR. GOLDFINE: voted yes, would like to see the 2 year data before drug approval and more long term trials at launch

calopre 23-09-10 00:32

Cel-Sci Volume Soars, Price to Follow? PDF | Print | E-mail
Written by Vinny Cassano
Wednesday, 22 September 2010 00:00
1retweet01diggdiggCel-Sci shares were on the move Tuesday, jumping as much as twenty percent on volume that was ten times the daily average. No news was released in conjunction with the price and volume spike, but the recent start of the Multikine Phase III trial has renewed investor interest, especially after watching shares of Dendreon soar past the forty dollar mark after the success of Provenge.

Multikine, like Provenge, is an immunotherapy treatment designed to stimulate the body's immune system to fight cancer, and I believe that these treatments - and others like them still in development - will be looked back upon in history as a huge step forward for the treatment of cancer.

Multikine is unique in its own right because it is being tested as a first line treatment for head and neck cancer. Most immunotherapeutic cancer treatments are administered during the later stages of tumor progression after other treatments (chemo and radiation) have already been used.



CEL-SCI CORPORATION
0.73 +0.12 (+18.85%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.Tuesday's trading action could be a result of renewed interest in the stock, but it's also likely that last week's news release of the commencement of the Phase III trial in Mississippi was just a teaser of sorts, with more significant developments to follow. It's not safe to assume anything in the market, so the Phase III may be slow to ramp up, but speculation could be enough to drive CVM right back towards the one dollar mark, undoubtedly a welcome thought to those who have been loading up for fifty cents over the past few months.

Four million shares traded is a big deal for CVM these days, and combined with the twenty percent price spike, Cel-Sci is looking like a more significant move could be in store. At the very least, it's a stock to watch for the short term, and still one to accumulate for the long term based on the potential of Multikine.

I'll be holding for now, waiting to see how the action plays out for the rest of the week, but I'll definitely add more on any pullbacks.

Good to see Cel-Sci turning heads again; the most anticipated event for this company has been the start of the Phase III trial, and investors can finally feel confident that Multikine is moving forward as planned.

On another note, with a new 'super-bug' being mentioned in the news over the past few weeks, I wouldn't be surprised to see a LEAPS press release at some point in the near future.



Disclosure: Long CVM.

furo 23-09-10 11:45

Citazione:

Originalmente inviato da calopre (Messaggio 26600525)
Cel-Sci Volume Soars, Price to Follow? PDF | Print | E-mail
Written by Vinny Cassano
Wednesday, 22 September 2010 00:00
1retweet01diggdiggCel-Sci shares were on the move Tuesday, jumping as much as twenty percent on volume that was ten times the daily average. No news was released in conjunction with the price and volume spike, but the recent start of the Multikine Phase III trial has renewed investor interest, especially after watching shares of Dendreon soar past the forty dollar mark after the success of Provenge.

Multikine, like Provenge, is an immunotherapy treatment designed to stimulate the body's immune system to fight cancer, and I believe that these treatments - and others like them still in development - will be looked back upon in history as a huge step forward for the treatment of cancer.

Multikine is unique in its own right because it is being tested as a first line treatment for head and neck cancer. Most immunotherapeutic cancer treatments are administered during the later stages of tumor progression after other treatments (chemo and radiation) have already been used.



CEL-SCI CORPORATION
0.73 +0.12 (+18.85%)

Intraday | 3 Month | 6 Month | 1 Year


Quotes delayed at least 20 mins.Tuesday's trading action could be a result of renewed interest in the stock, but it's also likely that last week's news release of the commencement of the Phase III trial in Mississippi was just a teaser of sorts, with more significant developments to follow. It's not safe to assume anything in the market, so the Phase III may be slow to ramp up, but speculation could be enough to drive CVM right back towards the one dollar mark, undoubtedly a welcome thought to those who have been loading up for fifty cents over the past few months.

Four million shares traded is a big deal for CVM these days, and combined with the twenty percent price spike, Cel-Sci is looking like a more significant move could be in store. At the very least, it's a stock to watch for the short term, and still one to accumulate for the long term based on the potential of Multikine.

I'll be holding for now, waiting to see how the action plays out for the rest of the week, but I'll definitely add more on any pullbacks.

Good to see Cel-Sci turning heads again; the most anticipated event for this company has been the start of the Phase III trial, and investors can finally feel confident that Multikine is moving forward as planned.

On another note, with a new 'super-bug' being mentioned in the news over the past few weeks, I wouldn't be surprised to see a LEAPS press release at some point in the near future.



Disclosure: Long CVM.

:clap::clap::clap:
Dici che è troppo tardi per entrare??
Ti faccio sempre i complimenti calopre, grazie 1000 per tutto

calopre 23-09-10 13:27

Citazione:

Originalmente inviato da furo (Messaggio 26603512)
:clap::clap::clap:
Dici che è troppo tardi per entrare??
Ti faccio sempre i complimenti calopre, grazie 1000 per tutto

prego, sto cercando di fare cassa per accumulare.

furo 23-09-10 16:00

Citazione:

Originalmente inviato da calopre (Messaggio 26604882)
prego, sto cercando di fare cassa per accumulare.

Quindi è ancora buona a sti prezzi?

calopre 23-09-10 17:24

Citazione:

Originalmente inviato da furo (Messaggio 26607399)
Quindi è ancora buona a sti prezzi?

ho già detto che non mi voglio sbilanciare e poi se entrare o meno su una azione è un fatto individuale che non posso incoraggiare o meno.
mi limito a fare delle considerazioni e le faccio sul forum giusto per evitare di parlare da solo di fronte al computer,e, mi ripeto che con cvm siamo di fronte a studi che rivoluzioneranno i pharma tradizionali con enormi benefici per tutti
con un ritorno economico che non si può neppure lontanamente quantificare e che non corrisponde certo ad una siffatta valutazione.
ora tutto ciò poteva essere una delle tante fobie che colpiscono chi opera in borsa,quando si da valore a qualcosa che non lo ha e viceversa , quando si vede bianco invece è nero.potrei sbagliarmi e vedere l'azione a 0,20 ma in questo caso triplicherei le mie forze per acquisirne il più possibile.

calopre 23-09-10 19:29

avanir per fine mese ottobre,potrebbe essere aprovato

furo 24-09-10 08:24

Citazione:

Originalmente inviato da calopre (Messaggio 26609175)
ho già detto che non mi voglio sbilanciare e poi se entrare o meno su una azione è un fatto individuale che non posso incoraggiare o meno.
mi limito a fare delle considerazioni e le faccio sul forum giusto per evitare di parlare da solo di fronte al computer,e, mi ripeto che con cvm siamo di fronte a studi che rivoluzioneranno i pharma tradizionali con enormi benefici per tutti
con un ritorno economico che non si può neppure lontanamente quantificare e che non corrisponde certo ad una siffatta valutazione.
ora tutto ciò poteva essere una delle tante fobie che colpiscono chi opera in borsa,quando si da valore a qualcosa che non lo ha e viceversa , quando si vede bianco invece è nero.potrei sbagliarmi e vedere l'azione a 0,20 ma in questo caso triplicherei le mie forze per acquisirne il più possibile.

Chiaro come sempre:clap::clap::bow::bow:

Che ne pensi di AEN?

calopre 24-09-10 08:54

Citazione:

Originalmente inviato da furo (Messaggio 26613648)
Chiaro come sempre:clap::clap::bow::bow:

Che ne pensi di AEN?

adeona ha un'ottima pipeline incentrata sul sistema nervoso centrale quindi
di estrema difficoltà ma di grande pregio. sse dovesse presentare dei buoni risultati potrebbefar parte di quelle aziende da acquisire.
Già perchè sono convinto che quello che doveva succedere da tempo ovvero M/A è inevitabile che avvenga adesso e non solo nei pharma.
scadenza brevetti e innovazione impongono delle acquisizioni e/o maggiori investimenti nella ricerca.

calopre 24-09-10 08:59

EU pulls plug on Glaxo's Avandia, Edwards shares soar on heart valve data. FDA approves Bionovo plan, shares rocket PDF | Print | E-mail
Written by Mary Davila
Thursday, 23 September 2010 19:02
2retweet12diggsdiggBelow is a look at some of the headlines for companies that made news in the healthcare sector on September 23, 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate, Menerba®, in a Type "B" or "End of Phase 2" meeting. With this designation, the decisions and agreements are now considered binding on the Company and the FDA.

"This CMC approval represents a revolutionary set of 'firsts'," said Dr. Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "This is the first time that the FDA's botanical drug development CMC guidance has been applied to an oral drug in a major indication. This is also the first time in recent history that the FDA has reviewed and approved a manufacturing plan for a drug with multiple actives derived from botanical source. In addition, Menerba, may be the first in class selective estrogen receptor beta modulator to go into late stage development. After long effort, innovations and interaction, Bionovo has now opened the door for a new paradigm in drug development."

With the FDA's approval of the Company's CMC plan, Bionovo is now in final discussions with the FDA to complete the design of the Phase 3 pivotal trials in the U.S. Having just successfully concluded a non-binding teleconference with the FDA, the Company has requested a face-to-face meeting, for the approval of the clinical development plan. The FDA is expected to grant such a meeting shortly.

Shares of Bionovo shot up more than 56%, rising 69 cents to $1.91.


EU pulls plug on Glaxo's Avandia, FDA restricts - European officials moved to pull GlaxoSmithKline's (GSK.L) diabetes drug Avandia off the market and U.S. authorities imposed tight restrictions over heart risks, effectively spelling the commercial end to the once-lucrative medicine. Once a top treatment choice and Glaxo's No. 2 seller, the rulings attempted to resolve a bitter, three-year debate over Avandia's safety that has dogged the reputation of the medicine and its maker, and divided staff inside the U.S. Food and Drug Administration.

The moves cleared the way for newer diabetes treatments to gain market share. Merck & Co's (MRK.N) drug Januvia and AstraZeneca Plc (AZN.L) and Bristol-Myers Squibb Co's (BMY.N) Onglyza were most likely to see a boost, analysts said. In coordinated statements, the FDA in Washington and the European Medicines Agency (EMA) in London said they agreed on the heart risks associated with the drug but had reached different conclusions on action.

The EMA said it would move to ensure Avandia was off the market in the next few months, while the FDA will require that U.S. patients first try other medicines to control blood sugar and acknowledge that they understand Avandia's risks.

Edwards shares soar on heart valve data - Shares of Edwards LifeSciences Corp (EW.N) jumped 13 percent on positive results from a closely watched study of its new heart valve that could spare patients open-heart surgery, paving the way for the first U.S. approval of the technology. The New England Journal of Medicine published results late on Wednesday for the company's Sapien aortic valve, which is implanted using a less-invasive alternative to open-heart surgery.

The data are also being presented at a major medical conference on Thursday. Patients in the study were too sick to endure an open-heart procedure, and half were expected to die within two years. "The results ... bode well for the approval of Sapien in the U.S. and for the rapid uptake of the device," said Wells Fargo Securities analyst Larry Biegelsen in a note to clients. The 358-patient trial, Cohort B of Edwards' Partner study, studied the valve for the treatment of severe aortic stenosis, a narrowing of the valve.

It met both of the clinical trial's main goals, Edwards said. "We are hard-pressed to find many faults with these data," William Blair analyst Ben Andrew said in a research note. The Sapien valve has been sold in Europe since 2007. The valve is threaded through arteries to the heart with a catheter inserted either in the groin or through a small incision between the rib cage, avoiding the need for open-heart surgery in which the heart is stopped.

Also Thursday:


Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that Novartis has notified Alnylam that they have formally selected their full and final list of 31 targets, for which they have exclusive rights to discover, develop, and commercialize RNAi therapeutics using Alnylam intellectual property and technology.

AmerisourceBergen Corporation (NYSE:ABC) today reported that in its fiscal year 2010 third quarter ended June 30, 2010, diluted earnings per share were $0.57, 36 percent increase, which includes a $0.05 benefit from special items.


The Board of Directors of AmerisourceBergen Corporation (NYSE:ABC) today authorized a new $500 million share repurchase program, effective after completion of the current repurchase program, which has approximately $98 million remaining.


Covidien (NYSE: COV), a leading global healthcare products company and recognized innovator in mechanical ventilation and respiratory care devices, today announced that the Puritan Bennett™ 560 ventilator is now available in Europe.

Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) today announced that Caldolor® (ibuprofen) Injection is gaining momentum and being approved for use in a growing number of medical facilities across the country.

Dr. Reddy’s Laboratories Limited (NYSE: RDY) today announced that its Annual Report on Form 20-F, containing its annual consolidated financial statements for the fiscal year ended 31 March, 2010 was filed with the United States Securities and Exchange Commission.

Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has begun to immunize subjects in a Phase 1b clinical trial of its Universal Flu Vaccine candidate.

GlaxoSmithKline (NYSE and LSE: GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions.

HeartWare International, Inc. (Nasdaq:HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Lazard Capital Markets Second Annual Circulatory Assist Device Day from 2:00-3:00 pm EDT on Wednesday, September 29.


Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Inovio scientists and collaborators of the company will present immune response and other important data for several of its DNA vaccines for infectious diseases at three major global vaccine conferences in late September and early October, 2010.

Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the U.S. Food and Drug Administration (FDA) conditionally approved the first of two planned cohorts of the randomized, controlled The PARTNER II Trial.

Martek Biosciences Corporation (Nasdaq:MATK) announced today that it has entered into an agreement to sell a significant portion of the assets at its Winchester, Ky., manufacturing site to Alltech, an animal health company headquartered in Nicholasville, Ky.


PAREXEL International Corporation (Nasdaq:PRXL) will release First Quarter Fiscal Year 2011 financial results on Monday, November 1, 2010 after the close of the stock market.


Vermillion, Inc. (Nasdaq:VRML), a molecular diagnostics company, today announced the appointment of Jeffrey M. Salzman as Corporate Director of Reimbursement.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has entered into an agreement to sell $375.0 million aggregate principal amount of 3.35% convertible senior subordinated notes due 2015.

YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), today reported operational and financial results for its fiscal year end, ended June 30, 2010.

il-parigino7 24-09-10 12:41

Hai notizie su cycc? Grazie ciao

fish782000 24-09-10 13:06

scusate...avete news o info perc nyse:cxm...

mi sa che per quella non manca molto...

grazie!

calopre 24-09-10 15:52

appena avrò qualche nuova ve la comunicherò

alex the first 24-09-10 20:43

sapete dirmi qualcosa in merito a SIGA e KERX??

calopre 26-09-10 17:17

Citazione:

Originalmente inviato da il-parigino7 (Messaggio 26617450)
Hai notizie su cycc? Grazie ciao

chiesto protocollo speciale fase tre

calopre 26-09-10 17:20

AVANIR Pharmaceuticals $AVNR up and moving. Significant increase in stock's Call options which is indicative of strong bullish sentiment.

John R. writes, "Have you seen the recent price action in Cel-Sci(CVM_)? There are claims of a buyout, rumors of a Teva Pharmaceuticals interest, LEAPS, new valuations up to $44 billion (LOL) and all the other old pump-and-dump claims this company has been through over the past decade. Please add some of your wisdom to this huge debacle being created on the wires and message boards. Thanks

andreati 26-09-10 17:29

Citazione:

Originalmente inviato da calopre (Messaggio 26634264)
AVANIR Pharmaceuticals $AVNR up and moving. Significant increase in stock's Call options which is indicative of strong bullish sentiment.

John R. writes, "Have you seen the recent price action in Cel-Sci(CVM_)? There are claims of a buyout, rumors of a Teva Pharmaceuticals interest, LEAPS, new valuations up to $44 billion (LOL) and all the other old pump-and-dump claims this company has been through over the past decade. Please add some of your wisdom to this huge debacle being created on the wires and message boards. Thanks

Inserito in pertafogliopharma CVM sulla correzione dai massimi di venerdi, con logica di accumulazione nei prox 2-3 mesi in attesa di futuri sviluppi visto le potenzialità che anche tu Calopre hai evidenziato.
Cmq come detto in altro thread aspetto news positive, molto, da HEB,,,
Saluti

tumiturbi 26-09-10 18:41

il mio portafoglio biokakke ;)

- agen
- apri (ex nexmed)
- cxm
- cycc
- ymi
- xoma

e in watch list
- gnvc
- aezs
- crxx
- appa
- diga
- cvm
- bnvi

in rosso quelle che mi sembrano + promettenti a breve

e poi un cippo di ctic solo per scommessa speculativa :p

calopre 26-09-10 18:49

29 CXM 30 CXM OGXI to begin Phase III trials in 2010 XOMA- Clinical Trials- 3Q10 PPCO- Phase IIa Trial Results PPCO - Phase II Clinical Data VRUS - Clinical Data

ultimi botti del mese

tumiturbi 26-09-10 18:52

Citazione:

Originalmente inviato da calopre (Messaggio 26634673)
29 CXM 30 CXM OGXI to begin Phase III trials in 2010 XOMA- Clinical Trials- 3Q10 PPCO- Phase IIa Trial Results PPCO - Phase II Clinical Data VRUS - Clinical Data

ultimi botti del mese

speriamo

qui a forza di AL LUPO AL LUPO stiamo invecchiando :D

il-parigino7 26-09-10 21:27

CALOPRE scusa e' positivo o negativo "chiedere protocollo speciale fase tre" a cycc
ciao grazie

aross 26-09-10 22:46

positivo. poi magari passano ad una SPA o una accelerated approval.. in base si risultati della fase III
Citazione:

Originalmente inviato da il-parigino7 (Messaggio 26635441)
CALOPRE scusa e' positivo o negativo "chiedere protocollo speciale fase tre" a cycc
ciao grazie


calopre 27-09-10 11:03

Key October FDA Catalysts - Part One PDF | Print | E-mail
Written by Patrick Crutcher
Monday, 27 September 2010 03:35
retweet00diggsdiggHere we review some upcoming FDA decisions to keep you informed on guard. Many susbcribers to BioMedRepreport's FDA catalyst calendar took positions before many of these companies started to gain momentum and volume. In many cases, we have also been featuring, examining and methodically interpreting the particulars and data behind some of these stocks.

We always teach BioMedReports readers to assume one thing: "The price of a biotech/pharma company's stock will go up as the key FDA decision dates and key clinical trial data approaches. So one of the most simple ways (and there are several) that investors make money is to buy stocks with key pending FDA catalysts 1-3 months BEFORE those dates arrive.

As the FDA decison date approaches, big crowds of speculators and traders start coming in to buy shares of the same stock. As supply runs out and demand goes up, so does the price of the stock. We invite you to get your daily updates to our FDA Calalyst and Clinical Trial Data Calendar, if you don't already subscribe to it. Get it here: http://biomedreports.com/fda-calendar/fda-calendar.html

Alexza Pharmaceuticals Inc.(NASDAQ: ALXA) has a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010(Monday) for AZ-004. Alexza filed the AZ-004 NDA on December 11, 2009 and is seeking marketing approval for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. We are bullish on ALXA’s approval chances. See our previous post on ALXA.

Initial coverage on ALXA: October FDA decision due for Alexza Pharmaceuticals - BioMedReports.com
Recent commentary on ALXA: Alexza Pharmaceuticals continues to look bullish - BioMedReports.com

Alkermes Inc.(NASDAQ:ALKS) has two PDUFA dates. ALKS has a PDUFA date of October 12, 2010(Tuesday) for the sNDA of VIVITROL. If approved for opioid dependence, VIVITROL would be the first and only non-narcotic, non-addictive medication for the treatment of opioid dependence available in a once-monthly formulation. ALKS had a 11-2 positive vote of approval on September 16th from the FDA panel review.

Additionally, ALKS has another PDUFA date on October 22, 2010(Friday) for the NDA of BYDUREON. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes.

Based on the panel review for VIVITROL and the third submission of BYDUREON, it seems ALKS could likely see 2 FDA approval in October. See our previous research on ALKS.

Our take on ALKS: http://bit.ly/bK4lrX

AVANIR Pharmaceuticals (NASDAQ:AVNR)‎ has a PDUFA date of 10/30/10 (Saturday) for AVP-923 (formerly Zenvia). AVP-923 is a novel combination of dextromethorphan and quininide for the treatment of pseudobulbar affect (PBA) in patients with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). PBA is a neurologic condition characterized by involuntary, unpredictable and disruptive outbursts of laughing or crying in patients with certain underlying neurologic diseases or injuries. We are bullish on AVNR’s approval chances for AVP-923. AVNR has very positive analysts ratings and $7-9 target prices. See our previous post on AVNR.

Our opinion of AVNR: Investors Warming Up to AVNR - BioMedReports.com

Part two of this report will appear in this space tomorrow. Paid subscribers can access it now.

AllTrader69 27-09-10 13:41

i miei pharma
 
Citazione:

Originalmente inviato da calopre (Messaggio 26138840)
XOMA
NASDAQ LABOPHARM
NASDAQ ARYX THERAPEUTICS
NASDAQ ISTA PHARMACEUTICAL
NASDAQ LEXICON PHARMA
NASDAQ PONIARD PHARM
AMEX ULURU
manca exas da cui ancora una volta sono uscito per buon profitto e in attesa di rientrare
Praticamente vi propongo il mio portfolio sui titoli pharma
attendo di conoscere il vostro per un maggiore riscontro e conoscenza sui singoli titoli

un saluto a tutti del forum,
io ho un portafoglio titoli molto variegato, di titoli pharma ne posseggo 2:
1.CTIC - CELL THERAPEUTICS (-70%) dal prezzo di carico :wall::wall::wall:
2.ANX - ADVENTRX PHARMACTLS (-25%) ho deciso di tenerle quando ero a +350% :eek::eek::eek:

personalmente quest'ultima e' quella in cui credo di piu' ed ho grosse aspettative future,
speriamo che non mi deluda.

P.S. a dire il vero ne avevo anche un'altra che purtroppo sembra essere morta Altus Pharmaceuticals addio 2500$:o:o:o

esko 27-09-10 13:54

Cosa ne pensate di appy..........per me e' arrivato il momento di comprare

calopre 27-09-10 14:20

Citazione:

Originalmente inviato da AllTrader69 (Messaggio 26640335)
un saluto a tutti del forum,
io ho un portafoglio titoli molto variegato, di titoli pharma ne posseggo 2:
1.CTIC - CELL THERAPEUTICS (-70%) dal prezzo di carico :wall::wall::wall:
2.ANX - ADVENTRX PHARMACTLS (-25%) ho deciso di tenerle quando ero a +350% :eek::eek::eek:

personalmente quest'ultima e' quella in cui credo di piu' ed ho grosse aspettative future,
speriamo che non mi deluda.

P.S. a dire il vero ne avevo anche un'altra che purtroppo sembra essere morta Altus Pharmaceuticals addio 2500$:o:o:o

guarda che il portafoglio adesso è costituito da cvm e anvr,comunque ctic potrebbe fare un balzo in avanti al suo solito e anx rimane interessante

calopre 27-09-10 14:31

AVNR - After staying relatively flat for a while, AVNR’s run-up got kick started last week, after we published the article entitled “AVNR – PDUFA Date of 10/30/10“. On September 16th, AVNR was trading at $2.64, and it closed last week at $3.22. This represented a near 22% gain. There is still more than a month before AVNR’s PDUFA date of 10/30/10, and with Jefferies & Co giving AVNR a “BUY” rating (with a price target of $10), expect AVNR to heat up soon.

guerriero72 27-09-10 14:35

Citazione:

Originalmente inviato da calopre (Messaggio 26640845)
guarda che il portafoglio adesso è costituito da cvm e anvr,comunque ctic potrebbe fare un balzo in avanti al suo solito e anx rimane interessante

ciao calopre e complimenti...volevo se possibile, un tuo parere su 1 bio molto a sconto secondo il mio punto di vista e snobbata anche dal forum..per cash disponibile,prezzo sui minimi e pipeline molto vasta,sembra 1 delle migliori scommesse nel settore..ACAD..
:bow:OK!

calopre 27-09-10 14:59

Citazione:

Originalmente inviato da guerriero72 (Messaggio 26641080)
ciao calopre e complimenti...volevo se possibile, un tuo parere su 1 bio molto a sconto secondo il mio punto di vista e snobbata anche dal forum..per cash disponibile,prezzo sui minimi e pipeline molto vasta,sembra 1 delle migliori scommesse nel settore..ACAD..
:bow:OK!

domani conferenza,potrebbe dare segnali importanti, acadia ha una tecnologia innovativa nella sperimentazione di farmaci inerenti il sistema nervoso (prove e accertamenti di questi farmaci sono lunghi e difficoltosi)in fase due,quindi avrà dei normali rimbalzi nel momento in cui si manifestano situazioni positive e viceversa.due anni almeno per vedere che piega prenderà.

guerriero72 27-09-10 15:05

Citazione:

Originalmente inviato da calopre (Messaggio 26641464)
domani conferenza,potrebbe dare segnali importanti, acadia ha una tecnologia innovativa nella sperimentazione di farmaci inerenti il sistema nervoso (prove e accertamenti di questi farmaci sono lunghi e difficoltosi)in fase due,quindi avrà dei normali rimbalzi nel momento in cui si manifestano situazioni positive e viceversa.due anni almeno per vedere che piega prenderà.

qui 2 farmaci sono in fase 3...Acadia Pharmaceuticals - Pipeline ....:mmmm::confused:
grazie comunque:)OK!

calopre 27-09-10 15:22

Citazione:

Originalmente inviato da guerriero72 (Messaggio 26641538)
qui 2 farmaci sono in fase 3...Acadia Pharmaceuticals - Pipeline ....:mmmm::confused:
grazie comunque:)OK!

pimavanserin è in prevalente sviluppo di Biovail e acadia ha il diritto di commercializzazione fuori america,comunque anche questo è relativo, l'importante è che acad vada come meglio desideri.aspettiamo domani per maggiori notizie.

guerriero72 27-09-10 15:27

Citazione:

Originalmente inviato da calopre (Messaggio 26641806)
pimavanserin è in prevalente sviluppo di Biovail e acadia ha il diritto di commercializzazione fuori america,comunque anche questo è relativo, l'importante è che acad vada come meglio desideri.aspettiamo domani per maggiori notizie.

OK! buona giornata..:yes::bye:

calopre 27-09-10 17:59

CEL-SCI Corporation Receives Russian Federation Ethical Council Approval for Multikine Phase III Clinical Trial in Head and Neck Cancer



VIENNA, Va., Sep 27, 2010

(BUSINESS WIRE) -- CEL-SCI Corporation /quotes/comstock/14*!cvm/quotes/nls/cvm (CVM 0.75, +0.06, +7.91%) announced today it has received approval from the Ethical Council Affiliated with the Ministry of Healthcare and Social Development of the Russian Federation ("Ethical Council") for the Phase III clinical trial of Multikine(R), the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. CEL-SCI expects to have three clinical centers in Russia, out of an expected forty-eight clinical centers world-wide. Head and neck cancer is a major cancer in Russia.

CEL-SCI's Phase III clinical trial is an open-label, randomized, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only. North Mississippi Health Services was the first site in the United States to approve enrollment of subjects.

CEL-SCI's trial will be conducted in nine countries and is expected to be the largest clinical study of head and neck cancer ever conducted. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted.

Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in Phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration gave clearance for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.

calopre 28-09-10 11:10

CEL-SCI Corporation (NYSE AMEX:CVM) announced today it has received approval from the Ethical Council Affiliated with the Ministry of Healthcare and Social Development of the Russian Federation for the Phase III clinical trial of Multikine, the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. CEL-SCI expects to have three clinical centers in Russia, out of an expected forty-eight clinical centers world-wide. Head and neck cancer is a major cancer in Russia.

AllTrader69 28-09-10 11:32

Citazione:

Originalmente inviato da calopre (Messaggio 26640845)
guarda che il portafoglio adesso è costituito da cvm e anvr,comunque ctic potrebbe fare un balzo in avanti al suo solito e anx rimane interessante


spero che questo balzo arrivi presto e che sia soprattutto duraTORO :D, a tal proposito proprio oggi ho mediato un po' il prezzo di carico (il-70% non mi andava proprio giu)

per quanto riguarda anx credo che la fase interessante sia molto vicina,

buona giornata a tutti

fish782000 28-09-10 12:39

Citazione:

Originalmente inviato da calopre (Messaggio 26640845)
guarda che il portafoglio adesso è costituito da cvm e anvr,comunque ctic potrebbe fare un balzo in avanti al suo solito e anx rimane interessante

ctic...
Sempre ferma.....

Misteri....

calopre 28-09-10 12:55

non mi piace scrivere di ctic, per altro viè un altro forum che la tratta adeguatamente,
comunque sappiate che costituisce DIPENDENZA,è stata un guaio per molti ha fatto guadagnare altri come in tutte le cose.
non potete immaginare quanto può scendere prima di rilasciare una qualche dichiarazione e/o ottener qualche risultato che la riporti in alto.Prudenza

fish782000 28-09-10 15:15

Citazione:

Originalmente inviato da calopre (Messaggio 26651488)
non mi piace scrivere di ctic, per altro viè un altro forum che la tratta adeguatamente,
comunque sappiate che costituisce DIPENDENZA,è stata un guaio per molti ha fatto guadagnare altri come in tutte le cose.
non potete immaginare quanto può scendere prima di rilasciare una qualche dichiarazione e/o ottener qualche risultato che la riporti in alto.Prudenza

Quoto totalmente ...!

calopre 28-09-10 15:39

Key October FDA Catalysts - Part Two PDF | Print | E-mail
Written by Patrick Crutcher
Tuesday, 28 September 2010 00:00
retweet0The summer has come to an end, and so has the market slump that came with it. Stocks are on track to close September with the biggest monthly gains in over a year. Such is the word from a CNN Money report published last Friday. According to the network, the Dow has rallied 8.4% this month, which would be the best monthly gain since July 2009, when the blue-chip index added 8.6%. The latest lift also puts the Dow on track for its best September since 1939, when it rose 13.5%. The S&P has rallied 9.5%, the largest increase since April 2009, and the Nasdaq has surged 12.6%, the biggest jump since October 2002.
Last week, stocks rose more than 2% after the major indexes broke above key technical levels early in the week. That encouraged investors to keep the momentum going, and stocks ended with a rally to fresh four-month highs.

Without getting into too much detail, we want to follow up part one of this report and briefly mention some of the other notable big decisions that are coming up in October. Be sure to mark your calendars for these fireworks! We'll have more coverage and analysis of these stocks in the weeks ahead.

Human-Genome Sciences Inc.(NASDAQ:HGSI) has a FDA decision on 10/04/10(Monday) HGSI for their NDA for ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. Zalbin is partnered with Novartis(NVS). HGSI does not expect approval at this time based on preliminary discussions with the FDA, in particular the FDA has concerns over the risk benefit assessment of Zalbin. In April 2010, HGS announced that Novartis withdrew its Marketing Authorization Application for JOULFERON from the European Medicines Agency.

Don’t forget that HGSI has an all important FDA review panel on 11/16/10(Tuesday) and PDUFA date of 12/9/10(Thursday) for BENLYSTA®(belimumab) as a potential treatment for systemic lupus erythematosus (SLE). HGSI has an equal profit-sharing agreement with GSK for BENLYSTA. Look out for the panel documents a few days before hand. A positive panel vote would certainly send shares higher, as would approval. BENLYSTA has multi-billion dollar potential. HGSI has been seen as a likely M&A target by GlaxoSmithKline(GSK), their partner on Benlysta, darapladib and Syncria. For more information, see our article below.

Notes on HGSI rumors: http://bit.ly/9cOtmV

ISTA Pharmaceuticals Inc. (NASDAQ: ISTA) has a PDUFA date of 10/16/10(Saturday) for the sNDA for developing a once-daily version of Xibrom, or XiDay, for the treatment of ocular inflammation and pain following cataract surgery. ISTA forecasts sales from its Xibrom franchise to be in the around $100M.

Arena Pharmaceuticals Inc.(NASDAQ:ARNA) has a PDUFA date of 10/22/10(Friday) for Lorquess(lorcaserin), for the treatment of obesity and weight-loss. ARNA received a negative vote of approval during the FDA panel review on 9/16/10. Approval seems unlikely at this point given safety concerns surrounding Lorquess.

VIVUS Inc.(NASDAQ:VVUS) has a PDUFA date of 10/28/10(Thursday) for Qnexa, for the treatment of obesity. VVUS received a negative vote of approval during the FDA panel review on 7/15/10. Approval seems unlikely at this point and it’s unclear how much their 2-year data will help. Notably, Qnexa showed the most promise out of all the obesity drugs, in terms of efficacy.

Biodel Inc(NASDAQ:BIOD) has a PDUFA date of 10/30/10(Saturday) for the approval of their NDA on Linjeta™, for the treatment of diabetes. Linjeta is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. Approval would certainly send this small biotech skyward.

October is looking to be a pretty big month in biotech! Smart moves in October could certainly be very rewarding. Make sure to be thorough in your review of any company, especially with such important decisions coming soon that could radically effect the price. We will keep you updated.



Disclosure: No Positions

calopre 28-09-10 18:03

Le parti di Avanir si arrampicano mentre la decisione della FDA sulla droga si avvicina a
27 settembre 2010 3:00 PM ET
INDIANAPOLIS (AP) - parti di Avanir Pharmaceuticals Inc. arrampicate lunedì, come la data regolatrice di decisione per il candidato della droga del cavo dell'azienda si avvicina.

LA SCINTILLA: Il Aliso Viejo, California, azienda sta cercando l'approvazione per la droga AVP-923, precedentemente denominata Zenvia, come trattamento per l'influenza pseudobulbar, o gli scoppi impressionabili involontari connessi con la malattia o la ferita del cervello. L'Organismo di controllo degli alimenti e dei farmaci progetta di prendere una decisione entro il 30 ottobre.

LA GRANDE IMMAGINE: In 2006, la FDA ha chiesto più informazioni sulla droga di considerarla per approvazione. L'azienda ha iniziato uno studio supplementare della in ritardo-fase su una versione della basso-dose della droga in 2007 che seguono un accordo con l'agenzia ed ha presentato che dati all'inizio di quest'anno.

ANALISI: La gente sta sviluppando sempre più comoda, poichè effettuano la loro ricerca, con la probabilità dell'approvazione della droga, l'analista Andrew Fein di Co. & di Jefferies ha detto. Caviglia le probabilità della droga di approvazione a 80 per cento o più su.

L'analista Ritu Baral di Canaccord ha detto che è più sicura ora che la droga sarà approvata dopo avere veduto più particolare sui dati di sicurezza in settimane ultime.

“Tutta osserva molto pulita,„ ha detto.

Baral pensa che le probabilità della droga di approvazione siano 60 per cento o migliori. Effettua una valutazione “dell'affare„ sulle azione con un obiettivo di $6 prezzi.

AZIONE DELLA PARTE: Su 12 centesimi, o su 3.7 per cento, a $3.34 del pomeriggio

calopre 30-09-10 16:38

l'andamento dei prezzi mi ha fatto venire qualche dubbio su Avnr, fare attenzione e regolatevi al meglio,rimango positivo su cvm medio- lungo. per chi le ha il 2 ottobre si potrebbe sapere qualcosa su myrx, altra buona bio.
a risentirci.

u055884 30-09-10 16:54

novita' su labopharm ve ne sono?

aross 30-09-10 20:43

Avanir potrebbe fare bene. mi sembra pero' che gli insider non facciamon molti acquisti..
Citazione:

Originalmente inviato da calopre (Messaggio 26679443)
l'andamento dei prezzi mi ha fatto venire qualche dubbio su Avnr, fare attenzione e regolatevi al meglio,rimango positivo su cvm medio- lungo. per chi le ha il 2 ottobre si potrebbe sapere qualcosa su myrx, altra buona bio.
a risentirci.


calopre 01-10-10 14:42

Hospira' Dyloject for acute moderate-to-severe pain in adults. FULL APPROVAL

Human Genome Sciences' Zalbin for hepatitis C. COMPLETE RESPONSE LETTER

Alexza Pharmaceuticals' AZ-004 for agitation in patients with schizophrenia or bipolar disorder. COMPLETE RESPONSE LETTER

Jazz Pharmaceuticals' JZP-6 for fibromyalgia. COMPLETE RESPONSE LETTER

Alkermes Vivitrol for opioid addiction. FULL APPROVAL

Arena Pharmaceuticals' lorcaserin for obesity COMPLETE RESPONSE LETTER

Amylin Pharmaceuticals, Alkermes and Eli Lilly's Bydureon for diabetes. COMPLETE RESPONSE LETTER

Vivus' Qnexa for obesity. COMPLETE RESPONSE LETTER

Avanir Pharmaceuticals' Zenvia for pseudobulbar affect. FULL APPROVAL

Forest Labs ceftaroline for Community Acquired Pneumonia. FULL APPROVAL

Biodel's Linjeta for diabetes. COMPLETE RESPONSE LETTER

le vostre opinioni?

per meglio comprendere

1. Full Approval: The big win, meaning the drug is approved and can be marketed for sale immediately.
2. Complete Response Letter: FDA has some concerns or issues (incomplete data, labeling, risk management, etc.) that prevent the drug from being approved immediately. In other words, the drug's approval is delayed for some reason.
3. No Decision: FDA chooses to extend the drug's review time, i.e., pushes out

mazzam 05-10-10 00:43

3 Allegato/i
settimanale
Allegato 1316461

giornaliero
Allegato 1316462



Stock Technical Analysis

alla rossa? :angry:

Allegato 1316463

calopre 05-10-10 16:24

EXAS
oltre ogni aspettativa, se tutto sarà ok a fine mese non so dove la porteranno

Tommy Gun 06-10-10 11:43

Citazione:

Originalmente inviato da u055884 (Messaggio 26679771)
novita' su labopharm ve ne sono?

UPDATE: Labopharm's Oleptro Drug Off To Slow Start >DDSSFont size: A | A | A1:58 PM ET 10/5/10 | Dow Jones
(Adds comment from company in paragraph 8 and updates stock price.)

By Andy Georgiades

Of DOW JONES NEWSWIRES

TORONTO (Dow Jones)--Labopharm Inc.'s (DDSS) latest drug launch, Oleptro, is off to a slow start.

According to data from IMS Health Inc. (RX), a total of 900 prescriptions for Oleptro have been written since its launch in early August by the Angelini Labopharm joint venture, analyst Douglas Miehm of RBC Capital Markets wrote in a report. By comparison, Labopharm's first drug, Ryzolt, surpassed 1,000 prescriptions in week two.

While Miehm questioned the early-August timing, he reiterated the "multiple hurdles" he sees facing Oleptro and said the slow start isn't a big surprise. "The questionable differentiating characteristics and pharmacoeconomic benefits stand out. Similarly, the major depressive disorder market is a more difficult arena than pain management to build momentum," Miehm wrote.

Oleptro is a once-daily version of anti-depressant trazodone, a drug that's long been available in immediate-release forms and has mainly been prescribed as a sleep aid. It's Labopharm's second U.S. drug launch after Ryzolt, a once-daily version of painkiller tramadol.

Labopharm has said its strategy is not to switch patients from generic versions of trazodone, but to provide a new treatment option for depression with a 145-person contract sales force that's targeting the top 23,000 prescribers most likely to adopt Oleptro.

Although the Oleptro launch is tracking well below Miehm's estimates, he has held off making any changes to his forecast until he determines the effect of sampling, which may have had "a more material negative impact on the launch."

He plans to continue monitoring weekly prescription data in hopes of seeing an uptick, but fears the Oleptro launch "may prove to be another disappointment."

In an e-mailed statement, Labopharm said: "Overall, we are pleased with the launch of Oleptro and continue to see a positive trend in feedback and usage of the product as we move deeper into launch. Success of Oleptro will be defined by ensuring these trends continue as awareness and experience with the product grows."

In Toronto Tuesday, Labopharm shares are down 2 Canadian cents at 98 Canadian cents on about 95,400 shares.

-By Andy Georgiades; Dow Jones Newswires; 416-306-2031; andy.georgiades@dowjones.com

fish782000 06-10-10 11:50

Citazione:

Originalmente inviato da calopre (Messaggio 26725613)
EXAS
oltre ogni aspettativa, se tutto sarà ok a fine mese non so dove la porteranno


non penso salga piu' di cosi'.....

calopre 06-10-10 12:15

In late July we knew we had a special opportunity to play a great run-up. In fact, note the first few sentences of our article from July 26th (LINK)

“It is not often that I get excited about playing clinical trials. Generally I feel that they are too risky, as the majority of the time there is not a set catalyst date to allow for a run-up. What can happen with clinical trials and data validation studies are the results are announced unexpectedly. You may go to bed with $5 shares and wake up with $1 shares. However, there is the rare occasion when we have the opportunity to play the run-up on a clinical trial…. EXAS (Exact Sciences) is one of these rare occasions, and the prospects are exciting.”

At the time of this article, just 10 weeks ago, EXAS was trading in the high $3 range. I opened my initial position at $3.84. Today EXAS closed at $7.57, a gain of 97%. On August 12th I wrote in the forums (LINK):

“I think the Oct $5 calls are a bargain right now at $.45… I’m holding 65 contracts now. Two weeks before EXAS data release, they should be getting even more media attention. I expect it to be in the $6-$7 range by then.”


Those Calls we recommended at $.45 (I bought at $.35) are now worth $2.60, a gain of nearly 642%.

Take a look at the chart for EXAS:



EXAS has benefited from one huge factor- the lack of the FDA. For now, Exact Sciences fate is in it’s own hands, as well as in the results they will announce in late October at the American Association of Cancer Research conference. With nearly 100% gain is it time to take profits? We believe so, ALXA has reminded us all that taking profits is a good idea. Recently I have cut my personal position in half. However, each investor must decide what to do with their own shares.

My Thoughts:

EXAS recently filed for a $150M shelf. If they dilute prior to releasing the validation study results I will sell my remaining shares immediately. To me this is a sign of a lack of confidence in their product. In all likelihood they already know the results.

So if they do not dilute, what is the plan? Will I hold through the catalyst date? For a while I was planning on it. However, I have sided against it.

Why?

The stock has already doubled in value and I think most traders expect positive results. While there may be an initial spike during the results, we doubt many traders are planning on holding for years, during additional trials and through the grueling FDA process. This will cause more sellers than buyers – we would not be surprised to see the share price drop. (Buy on the rumor, sell on the news) Also, at some point EXAS is going to need to raise cash (hence the $150M shelf), and they would be smart to announce an offering immediately after the positive results, capitalizing on the spike and media attention.

Any way you look at it, whether you hold shares or options, EXAS has been an excellent play. We will remain on the lookout for more these rare clinical trial events with firm catalyst dates.

Tags: EXAS


Posted in Clinical Trial

6 Responses to “EXAS – An Amazing Run-Up”
Bob says:
October 5, 2010 at 7:39 pm
i bought those calls right after you at .55 and just sold at $2.55!! Thanks Bio, now I have to figure out this ALXA debacle…

Reply
GPCF says:
October 5, 2010 at 7:50 pm
I got out in the recent level off, but I am excitted to see what happens.

I don’t often take recommendations from people on the Internet but this one I did take and it turned to be one of the best plays of my year.

Reply
ale says:
October 5, 2010 at 7:51 pm
i have just started with biorunup method .

calopre 06-10-10 12:24

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 05, 2010.
Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI). The studies were conducted to evaluate the efficacy and safety of two dosage strengths of RHUCIN, an investigational drug, for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in an overreaction of the immune system.
RHUCIN significantly reduced the time to beginning of relief of symptoms for all anatomical locations studied at both dosage strengths compared to placebo.

Lead author Bruce Zuraw, M.D., said, "The publication of the results from these randomized controlled trials is an important step in educating the medical community about recombinant human C1INH for HAE patients with acute angioedema."

Shares rose 19 cents or 6.81% to $2.98.

CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received governmental approval from the Hungarian National Institute of Pharmacy to begin enrollment of subjects for a Phase III clinical trial of Multikine in Hungary. Multikine is the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. Hungary is one of nine countries to participate in this global Phase III trial.


Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

Also Tuesday:
Amgen (Nasdaq:AMGN) today announced that results from several important studies from the Company's oncology portfolio will be presented at the 35th European Society for Medical Oncology (ESMO) Congress, Oct. 8-12, 2010, in Milan, Italy.
AmStem Corporation (Pink Sheets: AMST), a leading provider of biotherapeutic and cosmetic stem cell products, stem cell collection and storage expertise and access to nanotechnology vital to stem cell research, announced today the appointment of Dr. Michael J. Glantz, M.D. to its Scientific and Medical Board of Advisors (SAMBA).
Apricus Biosciences (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Company has closed its previously announced securities offering, raising over $9.3 million in gross proceeds.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) will host a Research and Development Day for the investment community on Tuesday, October 19, 2010 from 8:00 a.m. to 12:00 p.m. at the St. Regis Hotel in New York City.
Celgene Corporation (NASDAQ: CELG) today announced the successful pricing of three series of senior unsecured notes for an aggregate principal amount of $1.25 billion.
Preclinical data was published today on research performed by Cytori Therapeutics (NASDAQ:CYTX) showing adipose (fat)-derived stem and regenerative cells (ADRCs), either fresh or banked, demonstrated statistically significant improvements in animal survival and kidney function in an acute kidney injury animal model.
Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced that Fresno Heart and Surgical Hospital in Fresno, California has purchased a Blood Volume Analyzer (BVA-100) to assist with the diagnosis and treatment of heart failure patients.
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced the publication of preclinical data demonstrating that PEG-SN38 (EZN-2208), the Company’s novel PEGylated DNA topoisomerase I inhibitor, led to significantly greater tumor regression as compared to CPT-11 (irinotecan) in both in vitro and in vivo models of pediatric neuroblastoma.
Express Scripts (Nasdaq:ESRX) has completed the spinoff of its Rx Outreach business unit to create a new independent, nonprofit charitable organization with the mission of improving access to prescription medicines for low-income, uninsured Americans and working families.
Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) will release its third quarter 2010 financial results on Wednesday, November 10, 2010, after the market closes.
GeckoSystems Intl. Corp. (PINKSHEETS:GCKO) announced today that they are very pleased with the recent press coverage they have received from Reuters.com.
Geron Corporation (NASDAQ:GERN) today announced that GE Healthcare has launched the first human cellular assay product for use in drug discovery and toxicity screening, developed under a license and alliance agreement between the two companies.
Life Technologies Corporation (NASDAQ:LIFE) announced today it will report its third quarter 2010 financial results on Tuesday, October 26, 2010, after market close. The company will also hold a conference call on the same day at 4:30 p.m. EDT to discuss operating results, as well as future expectations.
Mediware Information Systems, Inc. (NASDAQ: MEDW) announced that its hospital-based blood management technologies have successfully enabled the growth of one of the company's most prestigious blood bank customers.
.
NuVasive, Inc. (NASDAQ:NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that clinical evidence in support of XLIF® will be prominent at the NASS Meeting this year, which will take place from October 6th through October 8th, 2010, in Orlando, Florida.
Pegasystems Inc. (NASDAQ: PEGA), the leader in Business Process Management (BPM) software solutions and a leading provider of customer relationship management (CRM) solutions, today announced several enhancements that address the healthcare industry's critical business imperatives.
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN® (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI).
.
SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) today announced that Silicon Valley Bank (SVB), the primary subsidiary of SVB Financial Group (NASDAQ: SIVB), has increased the existing debt financing facility ("the Bank Line") to the Company's operating subsidiaries.
.
USANA Health Sciences, Inc. (NASDAQ: USNA) announced today that it will present at the Canaccord Genuity Healthy Living Conference in Boston. Jeffrey Yates, Chief Financial Officer, is scheduled to present to leading institutional investment representatives on Wednesday, October 13, 2010, at 8:55 a.m. ET.
UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce that in response to interest from the marketplace, the company intends to rapidly roll out the development of a residential sector air purifier offering features specifically designed for the residential marketplace.
VIVALIS (NYSE Euronext: VLS), a biopharmaceutical company, announced today that it has signed with an undisclosed partner an agreement to evaluate the EB66® cell line for the production of several, undisclosed therapeutic proteins.
Walgreens (NYSE:WAG) (NASDAQ:WAG) had September sales of $5.64 billion, an increase of 5.3 percent from $5.36 billion for the same month in fiscal 2010. Duane Reade stores, acquired in April 2010, contributed 2.8 percentage points to the total sales increase for the month.
Watson Pharmaceuticals, Inc. (NYSE:WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market rasagiline mesylate 0.5 and 1.0 mg tablets.

calopre 08-10-10 17:47

tutti titoli che iniziano per c
credo sia un titolo di valore CPIX

calopre 09-10-10 18:46

Citazione:

Originalmente inviato da calopre (Messaggio 26763951)
tutti titoli che iniziano per c
credo sia un titolo di valore CPIX

Caldolor® (ibuprofen) Injection Gaining Approval on Formulary at U.S. Medical Centers PDF | Print | E-mail
Friday, 24 September 2010 04:01
retweet0
NASHVILLE, Tenn.-- Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) today announced that Caldolor® (ibuprofen) Injection is gaining momentum and being approved for use in a growing number of medical facilities across the country.

Several key U.S. hospitals, including Orlando Regional Medical Center, St. Elizabeth Healthcare in the Greater Cincinnati region and the Joseph M. Still Burn Centers, have added the product to their formularies for patient use. Designed primarily for use in the hospital setting, Caldolor is the first injectable product approved for use in the United States for the treatment of pain and fever.

Orlando Regional Medical Center (ORMC) is one of more than 230 institutions that have granted formulary approval since the drug's September 2009 launch. The 808-bed hospital serves as Central Florida's only Level One Trauma Center.

"Since the introduction of Caldolor at ORMC I have had the opportunity to use the product in a variety of patients, but most notably in my trauma patients," said Dr. John T. Promes, Director of Trauma Services and Associate Director for Surgical Education at Orlando Regional Medical Center. "Severe pain is difficult to treat, especially in patients with complex issues such as numerous fractures, impaired breathing from a collapsed lung and any number of other issues. Adding Caldolor to my practice has enabled me to decrease reliance on opioids and make patients more comfortable more quickly than with opioids alone. Getting patients moving around sooner can lead to faster recovery and decreased potential need for transfer to the intensive care unit. While opioids alone generally mask pain, adding Caldolor represents a new and multi-faceted approach to pain management, allowing me to treat pain at the source."

In clinical trials, using Caldolor as adjunct therapy has demonstrated pain relief above and beyond that which was provided by narcotics alone, while also reducing narcotic use. A recently published clinical trial shows that dosing Caldolor at induction of analgesia and post-operatively is effective in treating pain and reducing morphine use in adult patients. The newly published study entitled "A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients" appeared in the August 2010 edition of the peer-reviewed journal Pain Medicine and concludes that IV ibuprofen significantly decreased pain with movement by 26% (p<0.001) and decreased morphine use by 31% (p<0.001) when compared with placebo. There was no significant difference between placebo and IV ibuprofen in the number of patients with bleeding adverse events, the incidence of blood transfusions or other serious adverse events. More patients receiving IV ibuprofen experienced vomiting and more patients receiving placebo experienced dyspepsia.

The World Health Organization has recommended a multi-modal approach to pain management, with non-opioid analgesics such as ibuprofen recommended as first-line treatment.(1) Caldolor offers IV delivery of ibuprofen to control pain while allowing physicians to limit opioid use. Reduction in opioid use could potentially reduce opioid-related side effects such as sedation, nausea, vomiting, cognitive impairment and respiratory depression.

Dr. Dean Adams, colon and rectal surgeon at St. Elizabeth Healthcare in Greater Cincinnati and owner of Colorectal Care of Northern Kentucky, has also seen a substantial improvement in patients recovering from colorectal surgeries when treated with Caldolor. Rated by HealthGrades as a Distinguished Hospital for Clinical Excellence, St. Elizabeth ranks in the top 5 percent in the nation for quality of care and is one of the oldest, largest and most respected medical providers in the Greater Cincinnati region.

"Using Caldolor to manage post-operative pain is providing a real benefit for my patients as they are reporting substantially lower levels of pain following surgery," said Dr. Adams. "Caldolor definitely reduces their narcotic consumption. This can speed recovery of gut function after bowel surgery, and a number of my patients have used little or even no narcotic after a colon resection. Caldolor has made a real improvement in post-operative pain control in my practice."

The Joseph M. Still Burn Center (JMS) in Augusta, Georgia, has found similar results in using Caldolor to treat fever and pain in burn patients. An independent burn facility with 59 beds, including 25 critical care beds, JMS is the largest burn center in the country and the third largest in the world.

"My experience with Caldolor in reducing fever in patients with severe burns has been excellent," said Dr. Richard J. Cartie, who practices critical care medicine at JMS. "These patients often suffer from intensely high fever, and burns are obviously also associated with severe pain. Caldolor is an ideal treatment option because it is an anti-inflammatory agent that quickly and effectively reduces fever while also controlling pain."

According to the American Burn Association, 1.1 million burn injuries require medical attention each year in the United States. Of these, approximately 50,000 burn injuries require hospitalization, 20,000 are major burn injuries affecting 25 percent of total body surface area and 4,500 people die. In addition, up to 10,000 people in the United States die every year from burn-related infections.(2)

"We believe that the clinical data supporting the safety and efficacy of Caldolor is being validated by the experiences of these and other premier institutions," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "The types and numbers of patients that stand to benefit from treatment with this product are just beginning to be discovered. We are thrilled to be on the forefront of what we believe is a breakthrough in the very broad spectrum of treatment for pain and fever."

Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as for the reduction of fever in adults. For full prescribing information, including boxed warning, visit CALDOLOR ® - The First and Only IV Ibuprofen for Pain and Fever.

References

(1) World Health Organization. Pain relief and palliative care. In: Clinical Management of HIV and AIDS at District Level. New Delhi, India: WHO Regional Office for South-East Asia Web site. http://www.searo.who.int/linkfiles/p...tions_ch11.pdf. Updated April 26, 2006. Accessed July 15, 2009.

(2) American Burn Association (2002). Burn Incidence Fact Sheet.

About Caldolor

Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in adults. It is the first FDA approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, including boxed warning, visit CALDOLOR ® - The First and Only IV Ibuprofen for Pain and Fever.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning and Kristalose® (lactulose) for Oral Solution, a prescription laxative. The Company also recently launched Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information on Cumberland Pharmaceuticals, please visit Cumberland Pharmaceuticals Inc. | Targeting Patient Needs.

Important Note Regarding Forward-Looking and External Statements

This press release contains forward-looking statements that reflect Cumberland's current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of operations are subject to influences outside of the Company's control. Risk factors that could materially affect results of operations include, among others, those factors discussed in Cumberland's Annual Report on Form 10-K as filed with the SEC on March 19, 2010. There can be no assurance that results or developments anticipated by Cumberland will be realized or, even if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

This press release also contains external statements from healthcare professionals including language such as "decrease reliance", "more comfortable", "faster recovery", "moving sooner", "decreased need to transfer", "dramatic improvement" and "speeding recovery". Such statements are the expressed opinions of the quoted medical professionals based upon their individual experiences. Cumberland cannot independently verify these statements and readers are cautioned not to place undue reliance on them. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof.

Cumberland Pharmaceuticals Contacts:



Read the full report: caldolorar-ibuprofen-injection-gaining-approval-on-formulary-at-us-medical-centers | wall-street | penny-stocks

bedo 13-10-10 11:15

alks approvato farmaco......

Alkermes Announces FDA Approval of VIVITROL(R) for Prevention of Relapse to Opioid Dependence - MarketWatch

calopre 15-10-10 12:24

forse è arrivata l'ora diHEMISPHERx Biopharma (AMEX:HEB)

aross 15-10-10 13:00

sito per valutazione titoli biotech
 
Ciao Calo, giorovagando sul web ho trovato questo sito che mi sembra MOLTO interessante:
EvaluatePharma - Welcome

Selezionando un titolo, troviamo oltre i bilanci anche il n° di molecole in sperimentazione.. Direi che su Arna ci sono dei numeri interessanti. Mentre Somx ha solamente n.1 molecola in studio, oltre a quella già in commercio

Saluti

andreati 15-10-10 13:47

Citazione:

Originalmente inviato da calopre (Messaggio 26825204)
forse è arrivata l'ora diHEMISPHERx Biopharma (AMEX:HEB)

Eventualmente in positivo mi auguro.
Cmq cercavo news o indicazioni che su pportassero la tua valutazione ma nn ho trovato niente.Se puoi darmi info sul tuo pensiero in merito a HEB ed al suo momento mi faresti cosa gradita.
Grazie .
Saluti

calopre 19-10-10 17:37

PDL BioPharma (PDL è il titolo che ha buoni margini di crescita
heb mi sembra uscito da tutte le traversie che lo hanno visto protagonista, è un ottimo pharma e dovrebbe tornare a splendere. niente di nuovo ma con l'arrivo delle influenze heb tornaprotagonista.

esko 19-10-10 17:46

Citazione:

Originalmente inviato da calopre (Messaggio 26864885)
pdl biopharma (pdl è il titolo che ha buoni margini di crescita
heb mi sembra uscito da tutte le traversie che lo hanno visto protagonista, è un ottimo pharma e dovrebbe tornare a splendere. Niente di nuovo ma con l'arrivo delle influenze heb tornaprotagonista.

pdl ma sulle elezioni anticipate che mi dici:d:d:d

calopre 19-10-10 17:55

.
PDLI 5.59 Solanezumab Alzheimer’s Phase 3
.
PDLI 5.59 Bapineuzumab Alzheimer’s Phase 3 Data 2012
.
PDLI 5.59 Lucentis RVO sBLA PDUFA Oct 22 2010
.
PDLI 5.59 Lucentis DME Phase 3
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 3 First-line trial start mid 2010
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 3 Second-line ongoing
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 2 Third-line - BLA filed 2010 poss
.
PDLI 5.59 Avastin Cancer - Ovarian Phase 3 Completed
.
PDLI 5.59 Avastin Cancer - Gastric Phase 3 Endpoint not met
.
PDLI 5.59 Avastin Cancer - Prostate Phase 3 Endpoint not met
.
PDLI 5.59 Avastin + docetaxel chemo Cancer - Metatastic Breast sNDA PDUFA Sep 16 '10, FDA mtg Jul20 voted NO
.
PDLI 5.59 Avastin + taxanes. Cancer - Metatastic Breast sNDA PDUFA Sept 16 2010
.
HEB con AMPLIGEN, mi piace

esko 19-10-10 17:58

Citazione:

Originalmente inviato da calopre (Messaggio 26865155)
.
PDLI 5.59 Solanezumab Alzheimer’s Phase 3
.
PDLI 5.59 Bapineuzumab Alzheimer’s Phase 3 Data 2012
.
PDLI 5.59 Lucentis RVO sBLA PDUFA Oct 22 2010
.
PDLI 5.59 Lucentis DME Phase 3
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 3 First-line trial start mid 2010
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 3 Second-line ongoing
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 2 Third-line - BLA filed 2010 poss
.
PDLI 5.59 Avastin Cancer - Ovarian Phase 3 Completed
.
PDLI 5.59 Avastin Cancer - Gastric Phase 3 Endpoint not met
.
PDLI 5.59 Avastin Cancer - Prostate Phase 3 Endpoint not met
.
PDLI 5.59 Avastin + docetaxel chemo Cancer - Metatastic Breast sNDA PDUFA Sep 16 '10, FDA mtg Jul20 voted NO
.
PDLI 5.59 Avastin + taxanes. Cancer - Metatastic Breast sNDA PDUFA Sept 16 2010
.
HEB con AMPLIGEN, mi piace

ALLA FACCIA DELLE PIPLINE :eek::eek::eek:

CavalierCocozza 19-10-10 18:04

Citazione:

Originalmente inviato da calopre (Messaggio 26865155)
.
PDLI 5.59 Solanezumab Alzheimer’s Phase 3
.
PDLI 5.59 Bapineuzumab Alzheimer’s Phase 3 Data 2012
.
PDLI 5.59 Lucentis RVO sBLA PDUFA Oct 22 2010
.
PDLI 5.59 Lucentis DME Phase 3
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 3 First-line trial start mid 2010
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 3 Second-line ongoing
.
PDLI 5.59 trastuzumab-DM1 Cancer - Breast HER2+ Phase 2 Third-line - BLA filed 2010 poss
.
PDLI 5.59 Avastin Cancer - Ovarian Phase 3 Completed
.
PDLI 5.59 Avastin Cancer - Gastric Phase 3 Endpoint not met
.
PDLI 5.59 Avastin Cancer - Prostate Phase 3 Endpoint not met
.
PDLI 5.59 Avastin + docetaxel chemo Cancer - Metatastic Breast sNDA PDUFA Sep 16 '10, FDA mtg Jul20 voted NO
.
PDLI 5.59 Avastin + taxanes. Cancer - Metatastic Breast sNDA PDUFA Sept 16 2010
.
HEB con AMPLIGEN, mi piace




Ciao.Seguo HEB anche se al momento non ho azioni(le ho avuto in passato e uscito con lieve loss)

Hai notizie a riguardo?

Mi sembra di aver letto che era a Novembre l'incontro con Fda per Ampligen...o sbaglio?

Mi piacerebbe sapere le tue opinioni riguardo Heb e Ampligen

Grazie in anticipo

calopre 20-10-10 10:51

heb al momento non dà notizie ma entro un paio di settimane sentiremo parlare di ampligen e della sua approvazione. un anno e 10 giorni circa dal momento del lancio di una molecola che può dare un uso applicativo multiplo, unica nel suo genere, e con effetti in tutti i casi più o meno validi ma di buona efficacia.
ampligen è la pipeline di base di HEB che è una eccellente bio ed il risultatodi tutto questo non potrà che essere positivo.

calopre 20-10-10 16:22

Cel-Sci Volume Soars, Price to Follow? PDF | Print | E-mail
Written by Vinny Cassano
Wednesday, 22 September 2010 00:00
retweet0Cel-Sci shares were on the move Tuesday, jumping as much as twenty percent on volume that was ten times the daily average. No news was released in conjunction with the price and volume spike, but the recent start of the Multikine Phase III trial has renewed investor interest, especially after watching shares of Dendreon soar past the forty dollar mark after the success of Provenge.

Multikine, like Provenge, is an immunotherapy treatment designed to stimulate the body's immune system to fight cancer, and I believe that these treatments - and others like them still in development - will be looked back upon in history as a huge step forward for the treatment of cancer.

Multikine is unique in its own right because it is being tested as a first line treatment for head and neck cancer. Most immunotherapeutic cancer treatments are administered during the later stages of tumor progression after other treatments (chemo and radiation) have already been used.

Tuesday's trading action could be a result of renewed interest in the stock, but it's also likely that last week's news release of the commencement of the Phase III trial in Mississippi was just a teaser of sorts, with more significant developments to follow. It's not safe to assume anything in the market, so the Phase III may be slow to ramp up, but speculation could be enough to drive CVM right back towards the one dollar mark, undoubtedly a welcome thought to those who have been loading up for fifty cents over the past few months.

Four million shares traded is a big deal for CVM these days, and combined with the twenty percent price spike, Cel-Sci is looking like a more significant move could be in store. At the very least, it's a stock to watch for the short term, and still one to accumulate for the long term based on the potential of Multikine.

I'll be holding for now, waiting to see how the action plays out for the rest of the week, but I'll definitely add more on any pullbacks.

Good to see Cel-Sci turning heads again; the most anticipated event for this company has been the start of the Phase III trial, and investors can finally feel confident that Multikine is moving forward as planned.

On another note, with a new 'super-bug' being mentioned in the news over the past few weeks, I wouldn't be surprised to see a LEAPS press release at some point in the near future.







Read the full report: cel-sci-volume-soars-price-to-follow | biotech-news | stock-tips

calopre 21-10-10 17:11

entrato anche in BIONOVO mi piace menerba e gli altri prodotti della pipeline

calopre 21-10-10 18:07

FDA tra novembre e dicembre solo sette responsi in programma,questo significa che verranno ripresi tutti i pharma che aspettano una risposta fda.si preannuncia un periodo caldo.

mi chiedo dove sono finiti tutti gli estimatori di HEB, che tanto battaglavano su questo titolo.

calopre 22-10-10 16:01

RGN da prendere in ottica 0,6 ,in discesa continua da quasi 5 anni è un pharma-cosmetico con prodotti di successo che potrebbero presto vedere la luce. ben amministrato,ha mostrato un'ottima resistenza. dovrebbe rimbalzare o chiudere.

calopre 22-10-10 16:21

A proposito di HEB
Kelvin: Dr. Lapp, you are one of the few Doctors who has not only met Dr. Carter and the rest of the lead staff at Hemispherx Biopharma, but have had a relationship with them for almost 2 decades. What in your opinion is the future of Ampligen? Can you give us any hope that it will be approved, and finally made available to patients beyond the "cost recovery" program?

Dr. Lapp: Yes, I can. Again, I am limited by regulation as to how much I can say, but let me say this... Last December the FDA responded to Hemispherx's New Drug Application with a "Complete Response Letter." This letter provided recommendations for improving the application, which implies that the drug is ultimately approvable. The Complete Response Letter suggested that Hemispherx perform one more study and clear up some questions about drug safety - specifically effects on immune activation and carcinogenicity. Dr. Carter, Dr. strayer, and senior members in the company all indicated that Hemispherx wants to pursue approval and has the wherewithal to do that.

Kelvin: When I search "Google Scholar" I see there are a number of published, journal articles on the efficacy of Ampligen in combination with other drugs. For example, last year during the swine flu scare, Ampligen was shown to augment flu medications, and make them work faster. In the future, if Ampligen is approved, could you see patients using Ampligen in combination with other treatments?

Dr. Lapp: Oh yes, absolutely. In the early days of CFS research, all the CFS guys and all the HIV guys would meet together, because Ampligen could potentiate so many of the AIDS medications. We've known this for years. So once approved, combination therapy with Ampligen would be a natural, a given.

They forgot to mention they have done Jack squat for the past 10 months when most companies would actually be WORKING to get it approved........

u055884 22-10-10 16:37

Citazione:

Originalmente inviato da calopre (Messaggio 26892259)
FDA tra novembre e dicembre solo sette responsi in programma,questo significa che verranno ripresi tutti i pharma che aspettano una risposta fda.si preannuncia un periodo caldo.

mi chiedo dove sono finiti tutti gli estimatori di HEB, che tanto battaglavano su questo titolo.

buon pomeriggio, posso sapere quali sono questi 7? grazie

andreati 22-10-10 17:37

Citazione:

Originalmente inviato da calopre (Messaggio 26903073)
A proposito di HEB
Kelvin: Dr. Lapp, you are one of the few Doctors who has not only met Dr. Carter and the rest of the lead staff at Hemispherx Biopharma, but have had a relationship with them for almost 2 decades. What in your opinion is the future of Ampligen? Can you give us any hope that it will be approved, and finally made available to patients beyond the "cost recovery" program?

Dr. Lapp: Yes, I can. Again, I am limited by regulation as to how much I can say, but let me say this... Last December the FDA responded to Hemispherx's New Drug Application with a "Complete Response Letter." This letter provided recommendations for improving the application, which implies that the drug is ultimately approvable. The Complete Response Letter suggested that Hemispherx perform one more study and clear up some questions about drug safety - specifically effects on immune activation and carcinogenicity. Dr. Carter, Dr. strayer, and senior members in the company all indicated that Hemispherx wants to pursue approval and has the wherewithal to do that.

Kelvin: When I search "Google Scholar" I see there are a number of published, journal articles on the efficacy of Ampligen in combination with other drugs. For example, last year during the swine flu scare, Ampligen was shown to augment flu medications, and make them work faster. In the future, if Ampligen is approved, could you see patients using Ampligen in combination with other treatments?

Dr. Lapp: Oh yes, absolutely. In the early days of CFS research, all the CFS guys and all the HIV guys would meet together, because Ampligen could potentiate so many of the AIDS medications. We've known this for years. So once approved, combination therapy with Ampligen would be a natural, a given.

They forgot to mention they have done Jack squat for the past 10 months when most companies would actually be WORKING to get it approved........

Purtroppo Calopre sono e siamo sempre a chiederti valutazioni o opinioni vista la tua esperta capacità sul settore.
Per non smentire ti chiedo se puoi . vista la mia impossibilità di traduzione compiuta. di darmi alcune indicazioni principali su quanto hai riportato.
Grazie.
Saluti

calopre 22-10-10 17:42

bnvi coheen compra i risultati sono buoni. arriverà a valori più consoni
calendario fda
gg 4 CADX 8.81
.
4 PVCT* 1.03

7 INCY* 16.56 RPRX* 1.29 FDA Grants Type B Meeting to Be Held November 8, 2010 to Discuss Phase III Protocols for Androxal

.
15 16 18 19 20
.
SNTS* 3.22 OXGN* 0.23 MELA 7.33 MYRX* 3.74 APRI* 1.69

HEB parere fda entro dicembre approvazione giugno 2011
validità della molecola AMPLIGEN elevata permette sviluppo farmaci in più settori per adesso tutto positivo.

andreati 22-10-10 17:56

Citazione:

Originalmente inviato da calopre (Messaggio 26904481)
bnvi coheen compra i risultati sono buoni. arriverà a valori più consoni
calendario fda
gg 4 CADX 8.81
.
4 PVCT* 1.03

7 INCY* 16.56 RPRX* 1.29 FDA Grants Type B Meeting to Be Held November 8, 2010 to Discuss Phase III Protocols for Androxal

.
15 16 18 19 20
.
SNTS* 3.22 OXGN* 0.23 MELA 7.33 MYRX* 3.74 APRI* 1.69

HEB parere fda entro dicembre approvazione giugno 2011
validità della molecola AMPLIGEN elevata permette sviluppo farmaci in più settori per adesso tutto positivo.

Bene che sia tutto positivo per ora.
Solo non capisco un passaggio e cioè il parere della FDA entro dicembre se positovo non equivale alla approvazione immediata di Ampligen invece che a giugno 2011?

calopre 23-10-10 15:19

no , è un parere pre approvazione come il passaggio da una fase all'altra.
AMEX:HEB) Hemispherx Biopharma, Inc. belonging to the Healthcare sector and Biotechnology industry currently is trading at a price of $0.53, a dramatic change of 4.2% from its previous day’s close. The stock traded at a volume of 107,350 compared to its average volume of 518.23K trading shares. The stock is trading with a gain of 4.09% from its open this morning. Currently, the company has a market capital of approximately 68.54M.

il-parigino7 23-10-10 22:25

Calopre hai buone notizie o date su CYCC?

calopre 24-10-10 16:00

Citazione:

Originalmente inviato da il-parigino7 (Messaggio 26911608)
Calopre hai buone notizie o date su CYCC?

al momento no ma è fra i titoli che dovrebbero fare bene.

il-parigino7 24-10-10 16:11

Il motivo ?

calopre 24-10-10 19:30

Citazione:

Originalmente inviato da il-parigino7 (Messaggio 26914297)
Il motivo ?

CYCC 1.62 Sapacitabine Cancer - NSCLC Phase 2 Interim .
CYCC 1.62 Seliciclib Cancer - Nasopharyngeal Phase 2 Ongoing CYCC 1.62 Seliciclib Cancer - NSCLC Phase 2b
è un titolo pieno di catalizzatori per i prossimi mesi praticamente come heb che però ha dalla sua l'approvazione e non il passaggio alla fase successiva e comunque cycc ha più volte goduto dell'attenzione degli investitori mentre heb deve riconquistarli con i fatti dopo tante delusioni. quindi regolati.

CavalierCocozza 24-10-10 19:44

HEB parere fda entro dicembre approvazione giugno 2011
validità della molecola AMPLIGEN elevata permette sviluppo farmaci in più settori per adesso tutto positivo.[/QUOTE]



Scusa calopre ma dove lo vedi che Fda dia un parere entro dicembre?

synej 24-10-10 20:22

VIVUS, Inc. (Nasdaq: VVUS) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa(R), for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010. In previously announced pivotal phase 3 trials, patients treated with all three doses of Qnexa achieved significant weight loss compared to placebo, and significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular, inflammatory and metabolic risk factors.

Saturday October 30, 2010 8:00 AM - 8:00 PM

Valeant Pharmaceuticals International announced that the U.S FDA has accepted for review the New Drug Application (NDA) seeking marketing approval for the investigational drug retigabine, a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures.
Note: The date entered for this event is based on an estimated Standard review which is 10-months from the date of NDA filing. According to the company the NDA was accepted for filing on December 30, 2009.


Thursday November 4, 2010 10:00 AM - 2:00 PM

Cadence Pharmaceuticals
, Inc. LogoCadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV(TM) (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.
On February 10, 2010, Cadence received a Complete Response letter from the FDA which indicated that the OFIRMEV NDA could not be approved due to deficiencies observed during the FDA's facility inspection of Cadence's third party manufacturer. The Complete Response letter did not cite any safety or efficacy issues or require that any additional studies be conducted prior to approval.
Cadence met with the FDA on April 16, 2010 to discuss the deficiencies outlined in the Complete Response letter, at which time the agency did not request any new safety, efficacy, or stability studies. Based upon Cadence's discussions with the FDA, Cadence resubmitted the NDA on May 4, 2010. The FDA has not yet indicated whether it plans to re-inspect the facility used to manufacture OFIRMEV.


Thursday December 9, 2010 9:00 AM - 5:00 PM

Human Genome Sciences, Inc. (Nasdaq: HGSI)
and GlaxoSmithKline PLC (GSK) today announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to BENLYSTA® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). A priority review designation is granted to drugs that, if approved, offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA has assigned belimumab a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010.
The Biologics License Application (BLA) for belimumab was submitted to the FDA on June 9, 2010, and includes the results of two pivotal Phase 3 clinical trials that treated a total of 1,684 autoantibody-positive patients with SLE. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and in consultation with the FDA.
“We are very pleased that FDA has chosen to grant priority review to belimumab, the first in a new class of drugs called BLyS-specific inhibitors,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We believe that the priority review designation speaks both to the significant medical need of people living with lupus and to the potential belimumab may hold as a new treatment option for these patients.”
Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK, said, “Belimumab is the first medicine for lupus that has completed Phase 3 trials with positive results. We look forward to continuing to work together with HGS to progress regulatory files and we hope that we will be able to deliver a new treatment option for patients living with lupus.”
GSK submitted a Marketing Authorization Application for belimumab to the European Medicines Agency (EMA) on June 4, 2010.


Wednesday December 29, 2010 9:00 AM - 5:00 PM

MannKind Corporation (NASDAQ:MNKD)
announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted, MannKind's resubmission of its New Drug Application (NDA) for AFREZZA(TM) (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of December 29, 2010.
In March 2010, MannKind received a Complete Response letter to its NDA for AFREZZA from the FDA requesting additional information. In response, MannKind has submitted clinical data from a recently completed efficacy study in patients with type 1 diabetes as well as updated pooled safety data related to AFREZZA and information on the comparability of MannKind's next-generation delivery system to the device that was used in pivotal clinical studies.
"We have worked diligently since March to prepare our resubmission and we are confident that we have addressed the requests that were outlined by the FDA," said Alfred Mann, Chairman and Chief Executive Officer. "We will continue to work closely with the FDA during this final stage of the review process. We firmly believe AFREZZA has the potential to address a poorly-met need in diabetes therapy. Our primary goal is to make this novel therapeutic option available to patients as soon as possible."


Friday December 31, 2010 10:00 AM - 2:00 PM

Phase III trials of OGX-011 in first- and second-line advanced prostate cancer and non-small cell lung cancer are expected to begin in 2010 and early 2011
OncoGenex and Teva Pharmaceuticals entered into a global license and collaboration agreement to develop and commercialize OGX-011. Teva and OncoGenex will collaborate on a global Phase III clinical program, with two Phase III clinical trials expected to be initiated in 2010: a Phase III Study for Second-line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC) and a Phase III Study in First-Line Chemotherapy for Metastatic CRPC. An additional Phase III Study in First-Line Treatment of Advanced, Unresectable Non-Small Cell Lung Cancer (NSCLC) is intended to be initiated by early 2011.
OGX-011 is a Phase III cancer therapy designed to inhibit cancer treatment resistance. OGX-011 is expected to be used as adjunct therapy to enhance the effectiveness of chemotherapy and has shown promising results when added to currently available chemotherapies in several tumor types addressing a significant unmet medical need.OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance, and has completed Phase II clinical trials in prostate, lung and breast cancer. OGX-011 has received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel.

calopre 25-10-10 00:04

Citazione:

Originalmente inviato da CavalierCocozza (Messaggio 26915470)
HEB parere fda entro dicembre approvazione giugno 2011
validità della molecola AMPLIGEN elevata permette sviluppo farmaci in più settori per adesso tutto positivo.



Scusa calopre ma dove lo vedi che Fda dia un parere entro dicembre?[/QUOTE]

Caro Cavaliere,sa bene che non può essere scritto da nessuna parte,ma leggendo sui vari siti di Heb e della progressione degli studi e dei risultati raggiunti si arriva alla conclusione già espressa 8-10 mesi all'approvazione e parere fda entro due mesi massimo. AMPLIGEN non è un placebo, era efficace
ed innovativo solo qualche effetto collaterale non ben analizzato, adesso è stato dimostrato che più si somministra più aumenta la tollerabilità e diminuiscono eventuali effetti collaterali. quindi salvo sorprese o false informazioni siamo , bene o male che sia ,alle fasi finali.

calopre 26-10-10 11:22

High impact catalysts mark this week in healthcare sector PDF | Print | E-mail
Written by Patrick Crutcher
Tuesday, 26 October 2010 00:00
retweet0As we told our subscribers over the weekend, this week is marked with several high-impact catalysts that investors and traders should be monitoring. Below we have some commentary on the 5 events that are going to be on everyone's watchlist.


Arena Pharmaceuticals Inc.(NASDAQ:ARNA) received a Complete Response Letter(CRL) from the FDA regarding their NDA for Lorcaserin. The FDA cited a number ofnon-clinical and clinical reasons for their decision including marginal efficacy, rat tumors, and recommended that ARNA submit the final study report of the BLOOM-DM(Lorcaserin in diabetes) trial.

I don’t see this news as positive in any way. There appear to be too many what-if’s along the road for ARNA. BLOOM-DM trial results aren’t likely to be significant for their case due to marginal efficacy. It’s also unclear how much work will be needed in order to alleviate the rat tumor issue. A resubmission from ARNA will certainly not happen until spring 2011, since it will take at least a month for them just to meet with the FDA, then there will be considerable work to be done.
ARNA receives CRL from FDA for Lorcaserin: fda-issues-complete-response-letter-for-lorcaserin-new-drug-application | wall-street | penny-stock-news

AVANIR Pharmaceuticals Inc.(NASDAQ: AVNR) has a PDUFA date of October 30th(Saturday) for AVP-923(dextromethorphan/quinidine) for the treatment of patients with a neurological condition known as pseudobulbar affect (PBA). AVNR’s complete response includes data from their STAR trial which was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Both doses of AVP-923 met the primary efficacy endpoint in the STAR trial.

You can expect increased volume to continue into this week as investors finalize their decision on whether to hold thru FDA approval. It is possible that AVNR will hear from the FDA before Saturday. AVNR management has answered questions about the safety data in the STAR trial and most potential issues appear accounted for. The active ingredient in AVP-923 is in most cough suppressants sold over-the-counter and quinidine decreases gastrointestinal adverse events. I believe AVNR has demonstrated that AVP-923 offers the FDA an acceptable efficacy/safety profile for treatment of PBA.

AVNR Q&A about Safety Data safety-data-explained-for-upcoming-fda-decision | biotech-news | stock-tips

Biodel Inc.(NASDAQ: BIOD) has a PDUFA date of October 30th(Saturday) for Linjeta, which is a new injectable formulation of rapid-acting insulin for the treatment of type 1 and type 2 diabetes. Linjeta also appears to cause less weight gain and lower incidence of hypoglycemia, which are common side effects of current treatment options. BIOD also used the 505(b)(2) NDA, which typically has lower regulatory risk.

Shares of BIOD have taken quite the beating throughout October falling 30%. Many questions surround their Phase 3 data and how the FDA will view certain data from India that appear anomalous. Non-inferiority of Linjeta to Humulin was achieved without the data from India, it wasn’t achieved when the data from India was included. If and when this reaches the market, Linjeta could be a better insulin treatment for diabetics, especially those prone to hypoglycemic episodes or weight gain.

EXACT Sciences (NASDAQ: EXAS) will be presenting the results of three pre-clinical validation studies at American Association of Cancer Research Conference(AACR) in Philadelphia on 10/28/10 at 1PM EDT(see link below). They expect to start their pivotal study during 2nd/3rdQ 2011 to eventually support a FDA filing in 2012. In late July(see link below), EXAS reported preliminary results demonstrating their DNA methylation technology “detected 100 percent of colorectal cancers and precancers at a specificity cutoff of 100 percent in a preliminary study with colorectal tissue.”

EXAS is up more than 130% from the July lows, so expectations for positive results are high. Positive results would lead the way forward for EXAS to capitalize on the colorectal screening market which sees roughly 25-30M screening tests per year, with another 20-25M patients who are not up-to-date with colon cancer screening. The company has been using 30% market penetration for their test which yields $1.2B market potential. There has also been noticable insider buying at EXAS. Keep in mind that EXAS has a $150M shelf registered, which is likely to be used once results are known.

EXAS 3Q 2010 Results, Validation Study Data Conference Calls - Exact Sciences Corporation - Exact Sciences to Host Third-Quarter 2010 Results, Validation Study Data Conference Calls

EXAS Methylation Detection Technology Achieves 100 Percent Sensitivity, Specificity Exact Sciences Corporation - Exact Sciences' Methylation Detection Technology Achieves 100 Percent Sensitivity, Specificity

VIVUS Inc.(NASDAQ: VVUS) has a PDUFA date of October 28th(Thursday) for Qnexa for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity. After the trading volatility that ARNA saw last week, it’s likely that VVUS could see some movement for those speculating on approval.

In my opinion, VVUS has a stronger case for approval than ARNA. Considering ARNA was given a CRL with uncertain terms, this could give VVUS a boost tomorrow. The FDA questioned the marginal efficacy of Lorcaserin(for ARNA), a problem that Qnexa does not have. Another important fact to consider: VVUS had an SPA for their pivotal trial results, which demonstrated very significant efficacy. Recently released results from their long-term(2-year) SEQUEL study did not show any safety problems and reiterated the considerable efficacy seen with Qnexa. Weight-loss of 11.4%(26 lbs) in the high-dose Qnexa and 10.4%(23 lbs) in the low-dose group. It is unclear if the FDA will have had time to review this data. They might not get approval now, but they appear to have the quickest route to approval.

VVUS 2-year data http://bit.ly/9xP1FG

Disclosure: Long AVNR



Read the full report: high-impact-catalysts-mark-this-week | biotech-news | stock-tips

puppibaluppi 26-10-10 14:04

calopre.... mi puoi speigare perchè ritieni possibile un responso fda per novembre-dicembre su heb .. per me è una notizia importante avendone a suo tempo acquistate parecchie.... io personalmente non ho trovato notizie a riguardo ma mi risulta che qualsiasi incontro con fda deve essere richiesto da heb con preavviso di 30 giorni ....

inoltre mi risulta che nessun protocollo sui trals di cui alla crl di dicembre scorso è stato concordato con l'fda in questi mesi....

ti ringrazio per il tuo contributo

exfumatore68 26-10-10 14:15

Calopre nella CRL che ti allego sotto in stralcio si richiede mi sembra di capire in modo tassativo un clinical study di almeno 6 mesi e su almeno 300 pazienti in grado di dimostrare l'efficacia di Ampligen
Quindi ritengo insufficienti i vari testucoli fin ora svolti dalla società cosa ne pensi??


"Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen® and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations"





Citazione:

Originalmente inviato da calopre (Messaggio 26917348)
Scusa calopre ma dove lo vedi che Fda dia un parere entro dicembre?

Caro Cavaliere,sa bene che non può essere scritto da nessuna parte,ma leggendo sui vari siti di Heb e della progressione degli studi e dei risultati raggiunti si arriva alla conclusione già espressa 8-10 mesi all'approvazione e parere fda entro due mesi massimo. AMPLIGEN non è un placebo, era efficace
ed innovativo solo qualche effetto collaterale non ben analizzato, adesso è stato dimostrato che più si somministra più aumenta la tollerabilità e diminuiscono eventuali effetti collaterali. quindi salvo sorprese o false informazioni siamo , bene o male che sia ,alle fasi finali.[/QUOTE]

legolego 26-10-10 14:31

Spesa Farmaceutica

--------------------------------------------------------------------------------

Mercato farmaceutico mondiale in crescita a $880 miliardi


11 ottobre 2010


Si stima che nel 2011 il mercato farmaceutico mondiale possa raggiungere gli 880 miliardi di dollari, con una crescita del 5-7% sul 2010. Un miglioramento, in termini economici, rispetto all'anno in corso, in cui si prevede una crescita del 4-5%. Lo rende noto un recente report dell'IMS, la società leader mondiale nella rilevazione dei dati sul consumo dei medicinali.

L'andamento è fortemente condizionato dal trend dei cosiddetti "pharmemerging markets", cioè i 17 paesi emergenti per quanto riguarda i consumi farmaceutici, che da soli oggi valgono 170-180 miliardi di dollari. Sono paesi in cui la spesa per i farmaci cresce a un ritmo molto sostenuto (15-17%).

Nel 2011, si prevede che in Cina il mercato dei farmaci occidentali varrà circa 50 miliardi di dollari, facendone il terzo mercato mondiale (dopo Usa e Giappone), con una crescita del 27%. Oltre alla Cina, questi paesi includono Brasile, Russia, India, Venezuela, Turchia, Polonia e Ucraina.
Visti questi dati ci è più facile capire come mai tutte le big pharma stanno espandendo le proprie reti di informazione medica in questo paese e stanno insediando anche centri di ricerca e produzione

In Usa, dove la spesa per I farmaci è molto elevate e la recessione è ancora in atto, nel 2011 la spesa per i farmaci crescerà "solo" del 3-5% e si assesterà sui 320-330 miliardi di dollari.

Anche in Europa i consumi sono stabili (1-3%) a causa degli sforzi degli Stati al fine di contenere la spesa farmaceutica. In totale, nel 2011 nel nostro continente si spenderanno 135-145 miliardi di dollari.

Nel 2011 perderanno la copertura brevettuale farmaci che oggi generano un fatturato di circa 30 miliardi di dollari, ampliando così il campo di azione dei generici e dei biosimilari. Anche se il pieno effetto della scadenza di questi brevetti si farà sentire solo nel 2012. Tra i brevetti in scadenza il prossimo anno vi sono quelli di Lipitor (novembre 2011), dell'antipsicotico Zyprexa e dell'antibiotico Levaquin. Il brevetto di Plavix, invece, scadrà nel mese di maggio del 2012.

Sono attese anche forti innovazioni farmacologiche per la prevenzione dello stroke, per la cura del melanoma, della sclerosi multipla, del tumore della mammella, e dell'epatite C. L'IMS prevede che nel corso del 2011 verranno lanciati alcuni nuovi potenziali blockbuster (farmaci con vendite superiori al miliardi di dollari): ticagrelor, apixaban, iniparib e telaprevir.

Comunicato dell'IMS

calopre 26-10-10 15:52

History of NCT00215813
Brief title: Study of Ampligen in Chronic Fatigue Syndrome
Record State: RELEASED

Updated View Type of info changed
2005_09_21 Study Nothing (earliest version on record)
2005_11_01 Study Changes Protocol, Administrative, Misc.
2005_12_08 Study Changes Internal-use (not shown)
2006_10_23 Study Changes Protocol, Recruitment, Misc.
2006_10_24 Study Changes Protocol, Recruitment, Misc.
2010_04_08 Study Changes Protocol, Recruitment, Location/Contact, Misc.
The New Ampligen Diaries per le ultime considerazioni

calopre 27-10-10 12:49

mi sembra interessante
ROCKVILLE, Md.--RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the Company” or “RegeneRx”) today announced that the abstract entitled Treatment of Acute Stroke With Thymosin β4 has been honored with a score in the top 10 percent of all abstracts presented at the American Heart Association’s specialty conferences during the year, and therefore has been selected for re-presentation as a poster at the AHA’s Scientific Sessions on November 15.

The Scientific Sessions will be held in Chicago from November 13 through 17.

“We congratulate Dr. Daniel C. Morris, senior staff physician, Department of Emergency Medicine, Henry Ford Health Systems and his team on this recognition of their important work”

“We congratulate Dr. Daniel C. Morris, senior staff physician, Department of Emergency Medicine, Henry Ford Health Systems and his team on this recognition of their important work,” said J.J. Finkelstein, president and chief executive of RegenerRx. “With more than 20,000 attendees at this significant conference, this poster presentation will provide greater visibility and broader reach for the potential use of Tβ4 to treat stroke. This exposure is particularly welcome at this time as we formulate our plans to advance Tβ4 into the clinic for various CNS indications and hold strategic partnership discussions,” Mr. Finkelstein added.

The research was performed under a Material Transfer Agreement between RegeneRx Biopharmaceuticals, Inc. and the Henry Ford Health System and was originally presented at the International Stroke Conference, San Antonio, TX, in February of this year. Dr. Morris and his researchers showed that TB4, administered to rats one day after embolic stroke, improved neurological functional outcome compared to control animals. Improvement in neurological function was measured at various time intervals over a seven week period and was statistically significant.



Read the full report: regenerx-announces-tb4-stroke-study-to-be-honored-at-american-heart-association-scientific-sessions | wall-street | penny-stock-news

calopre 27-10-10 13:01

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the Company” or “RegeneRx”) today announced that the following letter to stockholders will be posted today to the investor relations section of the Company’s web site at Utilizing Thymosin Beta 4 (T&beta;4) to develop drug candidates in three principal areas: dermal, ophthalmic, and cardiovascular wound healing. - RegeneRx
More on Press Releases
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Regenerx Biopharmaceuticals Inc.| RGN To Our Stockholders, As we enter the final quarter of 2010, we would like to review our Company’s recent progress while providing a blueprint for the coming months. We are proud of the tremendous strides made by RegeneRx Biopharmaceuticals in advancing the development of Thymosin beta 4 (Tβ4) in a number of clinical applications.
Tβ4 is a novel therapeutic peptide for tissue and organ protection, repair and regeneration. RegeneRx is developing a synthetic copy of this conserved molecule for pharmaceutical use. In preclinical studies Tβ4 was shown to promote progenitor cell differentiation and migration in the heart and central nervous system, promote angiogenesis in cardiac and dermal tissues, increase keratinocyte migration and collagen deposition and decrease inflammation by down-regulating inflammatory cytokines.
Each of our three products in clinical development – RGN-352, RGN-259 and RGN-137 – is a unique formulation of Tβ4.
RGN-352
RGN-352 is an injectable formulation of Tβ4 to treat cardiovascular and central nervous system diseases, as well as other medical conditions. Based on a large body of preclinical efficacy data, we initially are targeting RGN-352 for the treatment of acute myocardial infarction (AMI), or heart attack. We recently completed a Phase 1 trial, which showed RGN-352 to be safe and well-tolerated. Planning for the Phase 2 trial began in the second quarter of this year, a contract research organization (CRO) has been retained to manage the trial and the clinical protocol is expected to be submitted to the U.S. Food and Drug Administration (FDA) shortly. We anticipate enrolling the first of 100 patients during the first quarter of 2011 at approximately 25 clinical sites in the U.S., Israel and Russia with the goal of completing enrollment in the trial by the end of 2011. We will also have an interim evaluation at the midpoint of the trial. We recently received a $3 million, three-year development grant from the National Institutes of Health (NIH) to support our AMI program.

calopre 27-10-10 15:17

Cel-Sci: Impact on Cancer Immunotherapy? PDF | Print | E-mail
Written by Vinny Cassano
Sunday, 24 October 2010 04:24
retweet0CEL-SCI Corporation (AMEX:CVM) announced last week that seven hospital Institutional Review Boards (“IRB”) in India will begin enrollment for the pending world wide Phase III Multikine trial.

India looks to be a big player in the trial, with Cel-Sci expecting fifteen clinical centers out of an expected forty-eight clinical centers world-wide to be located in that country. Slowly, but surely, the Phase III approvals are rolling in, but as I've stated before - it's news of the trial commencement that investors and followers of Multikine's progression are waiting for. The site approvals are nice, but the slow tease is quickly becoming mundane. Let us know when the first patient has received the treatment and then we'll pop the Dom Perignon.

In the meantime, CEO Geert Kersten presented at a recent Precision IR virtual conference. Nothing very noteworthy came from this presentation, but Geert did reiterate quite a few key points regarding Multikine. He emphasized the fact that Multikine is intended to be a first line standard of care, different from any other cancer immunotherapy in what he called the "first generation" of immunotherapies.

Of note, Geert lumped Dendreon's Provenge in with that first generation.



Read the full report: cel-sci-multikines-impact-on-cancer-immunotherapy | biotech-news | stock-tips

calopre 29-10-10 12:44

momemto un pò buio per i titoli pharma,anche i migliori subiscono un pò questa negatività generalizzata,puntare adesso sul titolo giusto significa grossi guadagni, basta crederci fino in fondo e accumulare sempre più. esempio lampante exas e non è finita. bisogna trovare uno due titoli similari. ma quali? se potete non pompate il vs portfolio, ma segnalate titoli che abbiano un reale potenziale di crescita. i miei li conoscete già.
Vi faccio un esempio RGN a 0,24, chi lo conosce? dove sta l'imbroglio?
a me sembra che ad un anno possa pure andare a 7 dollari o no.

furo 29-10-10 15:51

Citazione:

Originalmente inviato da calopre (Messaggio 26975587)
momemto un pò buio per i titoli pharma,anche i migliori subiscono un pò questa negatività generalizzata,puntare adesso sul titolo giusto significa grossi guadagni, basta crederci fino in fondo e accumulare sempre più. esempio lampante exas e non è finita. bisogna trovare uno due titoli similari. ma quali? se potete non pompate il vs portfolio, ma segnalate titoli che abbiano un reale potenziale di crescita. i miei li conoscete già.
Vi faccio un esempio RGN a 0,24, chi lo conosce? dove sta l'imbroglio?
a me sembra che ad un anno possa pure andare a 7 dollari o no.

Non ho capito il perchè del crollo di Exas.
Quando ritorna buono per rientrare secondo te?

calopre 29-10-10 17:58

Citazione:

Originalmente inviato da furo (Messaggio 26978381)
Non ho capito il perchè del crollo di Exas.
Quando ritorna buono per rientrare secondo te?

da tre a nove in pochi mesi, figurati che sono entrato e uscito più volte sperando in un ritracciamento che prima non c'è mai stato, forse adesso riprenderà fiato per farci entrare più in basso ma ne dubito,è un titolo tosto in mano a cassettisti che lo aspettano molto in alto visto che ormai si preannuncia una sicura approvazione.forse un graficista ci potrebbe dire qualcosa in più.tieni conto che il primo target era su 8,50 ma se riuscissimo a riprenderlo a 6 sarebbe buona cosa.

calopre 30-10-10 13:06

rxnews-recap-for-10-29-10 | biotech-news | stock-tips

sbirro 30-10-10 13:26

APP Pharmaceuticals Announces Approval of Metoprolol Tartrate Injection, USP

Oct. 29, 2010 (Business Wire) -- APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Metoprolol Tartrate Injection, USP, and expects to launch the medication soon.

Metoprolol Tartrate Injection, USP is therapeutically equivalent to the reference-listed drug Lopressor®, which is marketed by Novartis International AG. According to IMS Health, sales of this product in the United States for 2009 were approximately $13 million1.

“Heart disease is a leading cause of death in the United States and APP’s approval of Metoprolol Tartrate Injection, USP, will provide an affordable, generic treatment for millions of patients who suffer a heart attack or acute myocardial infarction each year,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “Additionally, this approval further expands APP’s growing Critical Care product line.”

APP’s Metoprolol Tartrate Injection, USP is AP-rated, preservative-free and bar-coded, and is packaged in single dose 5 mg/5 mL vials.

mastrodaniel 31-10-10 08:37

Citazione:

Originalmente inviato da calopre (Messaggio 26975587)
momemto un pò buio per i titoli pharma,anche i migliori subiscono un pò questa negatività generalizzata,puntare adesso sul titolo giusto significa grossi guadagni, basta crederci fino in fondo e accumulare sempre più. esempio lampante exas e non è finita. bisogna trovare uno due titoli similari. ma quali? se potete non pompate il vs portfolio, ma segnalate titoli che abbiano un reale potenziale di crescita. i miei li conoscete già.
Vi faccio un esempio RGN a 0,24, chi lo conosce? dove sta l'imbroglio?
a me sembra che ad un anno possa pure andare a 7 dollari o no.

io sono entrato su snt a 0.23$...anche questa mi pare altamente abbandonata..e sottovalutata..

calopre 31-10-10 12:41

tanto per regolarsi
NEW YORK - Quei gran geni del Dipartimento di giustizia americana si sono accorti dopo decine di anni e 40mila brevetti concessi che i geni dell'uomo non sono brevettabili. Per il mondo delle biotecnologie è una rivoluzione che fa esultare i propugnatori del brevetto libero e gridare allo scandalo le grandi compagnie che nella ricerca genetica a scopo di lucro hanno speso milioni di dollari. Adesso toccherà all'Ufficio brevetti federale decidere se accogliere o meno la decisione del ministero. Presa seguendo la procedura dell'amicus brief: che in giurisprudenza è l'intervento di una corte super partes cioè non chiamata direttamente in causa. La lite infatti è quella tra due non profit - l'American Civil Liberties Union e la Public Patent Foundation - e quella Myriad Genetics che con l'Università dell'Utah ha brevettato due geni chiamati BRCA1 e BRAC2. L'obiettivo della compagnia e dei ricercatori è scoprire se questi geni predispongono al tumore alle ovaie e al ****. Ma per farlo hanno proprio bisogno di brevettare le due "scoperte"? Un tribunale ha già decretato di no ma Myriad si è appellata e la causa continua.

Wolf82 31-10-10 13:01

Citazione:

Originalmente inviato da calopre (Messaggio 26975587)
momemto un pò buio per i titoli pharma,anche i migliori subiscono un pò questa negatività generalizzata,puntare adesso sul titolo giusto significa grossi guadagni, basta crederci fino in fondo e accumulare sempre più. esempio lampante exas e non è finita. bisogna trovare uno due titoli similari. ma quali? se potete non pompate il vs portfolio, ma segnalate titoli che abbiano un reale potenziale di crescita. i miei li conoscete già.
Vi faccio un esempio RGN a 0,24, chi lo conosce? dove sta l'imbroglio?
a me sembra che ad un anno possa pure andare a 7 dollari o no.

io segnalo CLDA, HGSI, IPCI,OGXI poi i soliti CYCC, KERX

oltre a questi ho anche HEB,SOMX,CTIC,ARNA

per quanto riguarda RGN ho visto la pipeline ha 3 farmaci (sclerosi multipla il + importante) tutti in fase 2.. ma ho un dubbio rischia il delisting?

calopre 31-10-10 16:54

Citazione:

Originalmente inviato da Wolf82 (Messaggio 26990949)
io segnalo CLDA, HGSI, IPCI,OGXI poi i soliti CYCC, KERX

oltre a questi ho anche HEB,SOMX,CTIC,ARNA

per quanto riguarda RGN ho visto la pipeline ha 3 farmaci (sclerosi multipla il + importante) tutti in fase 2.. ma ho un dubbio rischia il delisting?

dovrebbero essere ok fino al secondo trimestre 2011
A causa del nostro storico perdite da operazioni, NYSE Amex regole ci impongono di mantenere il patrimonio netto minimo 'di $ 6 milioni,
a meno che la nostra capitalizzazione di mercato superiore a $ 50 milioni. Noi non siamo attualmente in conformità con una di queste norme di iscrizione a listino. Nel secondo
trimestre del 2009, abbiamo presentato un piano rispetto al NYSE Amex previsto che la nostra capacità di riconquistare il rispetto delle norme oggetto
Ottobre 2010. NYSE Amex abbia accettato il nostro piano di conformità, che è soggetta a riesame periodico da NYSE Amex per determinare se ci sono
facendo progressi coerente con il piano.
17 novembre ci sono delle opzioni di acquisto a 0,45
comunque tutto dipende dall'andamento degli studi e relativi risultati,credo positivi.

calopre 31-10-10 20:15

us-may-end-patents-on-dna | biotech-news | stock-tips

RW1392 01-11-10 02:50

2 Allegato/i
Ciao Calopre :bow:

Citazione:

Originalmente inviato da calopre (Messaggio 26992957)
PDLI Biopharma dopo l'ultimo ritracciamento merita attenzione obj 9

Giornaliero e settimanale

calopre 01-11-10 17:52

anche avnr è andata in bene questa volta,complimenti a chi ci ha creduto fino alla fine.
grande selezione tra i titoli pharma,buona resistenza di heb e altri che entrano al centro dell'attenzione visto che ormai siamo alla fine delle bocciature e/o approvazioni.
speriamo di aver visto giusto.

calopre 01-11-10 19:10

sul forum 60 titoli diversi, troppi, non ci sono idee chiare.

calopre 02-11-10 12:05

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that it has been awarded $733,438 under HR: 3590 – Patient Protection and Affordable Care Act in immediately available funds. Under the Act, $1 billion was made available to stimulate promising therapeutic research for serious and life-threatening diseases by small biotechnology companies. Applicants were required to submit detailed information demonstrating that their research conformed to the parameters of the Act, along with a summary of qualifying expenditures that formed the basis for the award. RegeneRx submitted three applications, one for each of its drug candidates under active development. All three applications received an award.



Read the full report: rxnews-recap-for-11-01-10 | biotech-news | stock-tips

Wolf82 02-11-10 12:18

hai ragione troppi titoli sono stati proposti.. dobbiano sceglierne 3/4 in qualche modo

se hai tempo guarda la pipeline di IPCI per me ha potenzialità enormi peccato che non scambia molto..

aross 02-11-10 13:35

Ciao Calo, sei uscito da AVANIR? Temi un downtrend stile Somx?
Citazione:

Originalmente inviato da calopre (Messaggio 27003685)
sul forum 60 titoli diversi, troppi, non ci sono idee chiare.


calopre 02-11-10 16:55

avanir ha già dato per me
rgn riceve comunicazione delisting, chiede appello ma è a rischio
FDA approva piano per Menerba, menopausa Hot Flash Drug Candidate della Bionovo di fabbricazione

8:00a ET 23 settembre 2010 (PR NewsWire)
Bionovo, Inc (Nasdaq: BNVI, BNVID) ha annunciato oggi che l'US Food and Drug Administration (FDA) accettata chimica della società, produzione e controllo (CMC) piano per suo candidato di droga di piombo, Menerba(R), in un tipo "B" o "Fine della fase 2" riunione. Con questa denominazione, le decisioni e gli accordi ora sono considerati vincolanti per la società e la FDA.

"Questa approvazione CMC rappresenta un set rivoluzionario di"primati"," ha detto Dr. Isaac Cohen, del Bionovo, Presidente e amministratore delegato. "Questa è la prima volta che droga botanica sviluppo la FDA CMC orientamento è stato applicato a un farmaco orale in un'indicazione importante. Questa è anche la prima volta nella storia recente che la FDA ha esaminato e approvato un piano di produzione per un farmaco con più actives derivati dall'origine botanica.

Inoltre, Menerba, può essere il primo di classe estrogeno selettivo del recettore beta modulatore di andare in tarda fase di sviluppo. Dopo un lungo sforzo, innovazioni e interazione, Bionovo ha aperto le porte per un nuovo paradigma nello sviluppo del farmaco."

Con l'approvazione della FDA di CMC piano della società, Bionovo è ora in discussione finale con la FDA per completare la progettazione delle sperimentazioni cruciale fase 3 negli Stati Uniti Avendo concluso solo con successo una teleconferenza non vincolante con il FDA, la società ha chiesto un incontro faccia a faccia, per l'approvazione del piano di sviluppo clinico. La FDA dovrebbe concedere un simile incontro in poco tempo.

Come precedentemente comunicato, la società ha inoltre ricevuto approvazione del clinico e piano di sviluppo di CMC dall'Agenzia europea dei medicinali (EMA) per Menerba. L'EMA "orientamento finale" definisce il percorso clinico e regolamentazione europea autorizzazione per Menerba e inoltre è considerato vincolante e definitiva.

Su Menerba

Menerba è un candidato di farmaco orale, un derivato progettato per il trattamento sicuro ed efficacia di vasomotorie sintomi (vampate) connessi con la menopausa. Menerba è un estrogeno recettore beta (ER-b) selettiva farmaco, sviluppato come alternativa ai prodotti attualmente sul mercato, che hanno dimostrato di aumentare il rischio di carcinoma della mammella e del cancro uterino. Test clinici condotti finora, seguendo le indicazioni specifiche della FDA, hanno indicato che Menerba è efficace e sicuro.

Bionovo, Inc.
Bionovo è un'azienda farmaceutica incentrata sulla scoperta e sviluppo di sicuri ed efficaci trattamenti per la salute delle donne e il cancro, mercati con significativi bisogni insoddisfatti e miliardi di potenziali ricavi annuali. La società applica proprie competenze nella biologia del cancro per la progettazione di nuovi farmaci derivati da fonti botaniche con nuovi meccanismi di azione e la menopausa. Sulla base dei risultati delle sperimentazioni cliniche precoce e mid-stage, Bionovo ritiene che hanno scoperto nuove classi di farmaci candidati entro il loro ricco pipeline con il potenziale per essere leader nei loro mercati. Bionovo è acquartierato a Emeryville, in California ed è quotato sul mercato dei capitali al NASDAQ sotto il simbolo, "BNVI, BNVID". Per ulteriori informazioni su Bionovo e dei suoi programmi, visitare Bionovo: Developing Novel Solutions for Women's Health and Cancer Therapy.
Istruzioni di guardare avanti
aspettiamo rilancio del titolo,molto buono.

jellino 02-11-10 17:01

ciao Calopre
su snss cosa ne pensi?
alcuni mese mi dicesti che è una storia un po lunga
intanto le quotazioni sono quasi ai minimi
grazie

andreati 02-11-10 17:11

Citazione:

Originalmente inviato da calopre (Messaggio 27002604)
anche avnr è andata in bene questa volta,complimenti a chi ci ha creduto fino alla fine.
grande selezione tra i titoli pharma,buona resistenza di heb e altri che entrano al centro dell'attenzione visto che ormai siamo alla fine delle bocciature e/o approvazioni.
speriamo di aver visto giusto.

Se ho capito bene Calopre tu credi abbastanza convintamente su HEB e su Ampligen e credo anche che tu ti ci stai posizionando.
Quello che nn capisco è l andamento del titolo in borsa che nonostantejsi avvicini qualche potenziale news positiva, si presenta ancora con prezzi negativi e scarsi volumi.
E' vero che tutto può avvenire in un gg con i titoli bio , ma HEB ha bisogno di maggiore visibilità pena il disinteresse generale.
Saluti

calopre 02-11-10 18:36

Citazione:

Originalmente inviato da andreati (Messaggio 27014579)
Se ho capito bene Calopre tu credi abbastanza convintamente su HEB e su Ampligen e credo anche che tu ti ci stai posizionando.
Quello che nn capisco è l andamento del titolo in borsa che nonostantejsi avvicini qualche potenziale news positiva, si presenta ancora con prezzi negativi e scarsi volumi.
E' vero che tutto può avvenire in un gg con i titoli bio , ma HEB ha bisogno di maggiore visibilità pena il disinteresse generale.
Saluti

E' vero,oggi comunque leggevo di alcune scoperte relative alle difese immunitarie che se potenziate eviterebbero il ricorso a farmaci e guardacaso insieme a me altri hanno commentato facendo riferimento ad ampligen.
strano il comportamento di heb in borsa e nei comunicati ma anche questo potrebbe avere a che fare con lo scarso gradimento della FDA a comportamenti aggressivi nella valutazione di un pharma, vedi arna, dove si è parlato di un complotto.ma in realtà sono i dimagranti che non vengono approvati se presentano effetti collaterali. Ampligen sembra sicuro e valido, i piccoli rilievi riscontrati sembrano facilmente superabili e al momento non riscontro altro sulla abulica HEB.

calopre 02-11-10 18:55

Citazione:

Originalmente inviato da jellino (Messaggio 27014372)
ciao Calopre
su snss cosa ne pensi?
alcuni mese mi dicesti che è una storia un po lunga
intanto le quotazioni sono quasi ai minimi
grazie

Tra i partner di trial clinici, nominati dal Sunesis sono (i) ICON, un organismo di ricerca del contratto con capacità globali, perizia di ematologia e ampia fase 3 esperienza; (ii) Catalent Pharma Solutions, un fornitore globale leader di tecnologie avanzate e sviluppo, clinico, produzione e confezionamento di servizi, compreso il comparatore globale degli appalti, imballaggio secondario e logistica; e (iii) Cytel, un altamente considerato provider di servizi statistici. Sunesis ha anche mantenuto il Clinical Development Group, LLC per aumentare fase 3 il supporto strategico di sviluppo Sunesis per la prova di VALOR, compreso il reclutamento di gestione e paziente sito clinica. Individui chiavi del gruppo di sviluppo clinico hanno recente, multinazionale Phase 3 AML prova esperienza, compresi Ann Cahill, precedentemente il Vicepresidente clinica sviluppo di Vion Pharmaceuticals.

Circa Vosaroxin (ex voreloxin)

Vosaroxin, precedentemente noto come voreloxin, è un derivato quinolone anticancro di prima classe, o attacco rapido AQD, una classe di composti che non è stata usata in precedenza per il trattamento del cancro. Vosaroxin intercalates DNA sia inibisce topoisomerasi II, conseguente dipendono dalla replica, sito selettivo danni al DNA, arresto G2 e apoptosi. Sunesis piani per avviare il processo di VALOR, un multinazionale, randomizzato, doppio cieco, controllato con placebo, cruciale fase 3 trial clinico di vosaroxin in combinazione con citarabina in una popolazione paziente ad AML di casi di ricaduta/refrattari, nella seconda metà di quest'anno
scusa per la traduzione studio molto lungo che si concluderà forse nel 2012, durante questo periodo avrà bisogno di circa 30 milioni l'anno, i primi di ottobre credo abbia reperito 15 milioni circa a 0,42 di esercizio. se ci credi cassetto e via.

calopre 02-11-10 19:18

Citazione:

Originalmente inviato da Wolf82 (Messaggio 27009645)
hai ragione troppi titoli sono stati proposti.. dobbiano sceglierne 3/4 in qualche modo

se hai tempo guarda la pipeline di IPCI per me ha potenzialità enormi peccato che non scambia molto..

rexista è interessante, ha fatto il 100% negli ultimi sei mesi, da seguire.

jellino 02-11-10 19:22

Citazione:

Originalmente inviato da calopre (Messaggio 27016066)
Tra i partner di trial clinici, nominati dal Sunesis sono (i) ICON, un organismo di ricerca del contratto con capacità globali, perizia di ematologia e ampia fase 3 esperienza; (ii) Catalent Pharma Solutions, un fornitore globale leader di tecnologie avanzate e sviluppo, clinico, produzione e confezionamento di servizi, compreso il comparatore globale degli appalti, imballaggio secondario e logistica; e (iii) Cytel, un altamente considerato provider di servizi statistici. Sunesis ha anche mantenuto il Clinical Development Group, LLC per aumentare fase 3 il supporto strategico di sviluppo Sunesis per la prova di VALOR, compreso il reclutamento di gestione e paziente sito clinica. Individui chiavi del gruppo di sviluppo clinico hanno recente, multinazionale Phase 3 AML prova esperienza, compresi Ann Cahill, precedentemente il Vicepresidente clinica sviluppo di Vion Pharmaceuticals.

Circa Vosaroxin (ex voreloxin)

Vosaroxin, precedentemente noto come voreloxin, è un derivato quinolone anticancro di prima classe, o attacco rapido AQD, una classe di composti che non è stata usata in precedenza per il trattamento del cancro. Vosaroxin intercalates DNA sia inibisce topoisomerasi II, conseguente dipendono dalla replica, sito selettivo danni al DNA, arresto G2 e apoptosi. Sunesis piani per avviare il processo di VALOR, un multinazionale, randomizzato, doppio cieco, controllato con placebo, cruciale fase 3 trial clinico di vosaroxin in combinazione con citarabina in una popolazione paziente ad AML di casi di ricaduta/refrattari, nella seconda metà di quest'anno
scusa per la traduzione studio molto lungo che si concluderà forse nel 2012, durante questo periodo avrà bisogno di circa 30 milioni l'anno, i primi di ottobre credo abbia reperito 15 milioni circa a 0,42 di esercizio. se ci credi cassetto e via.

grazie
snss ha tempo fino al 31-03-2011 (lettera dal nasdaq) x quotare almeno 1$ x 10 giorni consecutivi
poi mi sembra le quote vendute era a 0,35 + dei warrant a 0,42 esercitabili 5 anni
certo tra adc r/s e altre quote vendute x far cassa le quotazioni ne potrebbero risentire

sbirro 02-11-10 21:48

CADX FDA approva booyah

calopre 03-11-10 00:22

heb perde i 51 cent e tende a precipitare,salvata sul finale dal ritorno dei volumi, circa 50 mila pezzi così come in apertura. qualche spiegazione?

calopre 03-11-10 12:50

ctic, accolta richiesta per rimanere a listino fino a maggio 2011.

calopre 03-11-10 12:56

Citazione:

Originalmente inviato da sbirro (Messaggio 27017865)
CADX FDA approva booyah

addirittura due giorni prima della scadenza.

calopre 03-11-10 17:50

ANX torna di moda
rprx si muove
(RTTNews) - Adventrx Pharmaceuticals Inc. (ANX: News ) said it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for its product candidate ANX-530, or Exelbine.
ADVENTRX Submits NDA for its lead drug candidate PDF | Print | E-mail
Written by Staff and Wire Reports
Wednesday, 03 November 2010 06:51
1retweet0ADVENTRX Pharmaceuticals (AMEX: ANX), whose focus is on in-licensing, developing, and commercializing proprietary product candidates for the treatment of cancer who announced yesterday that it had been awarded a total of $488,958 in grants under the qualifying therapeutic discovery project ("QTDP") program has issued significant news this morning.

ANX has made it known that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for one of its leading drug candidates ANX-530, or Exelbine. ANX-530 is an emulsion formulation of chemotherapy drug vinorelbine to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, as well as to treat advanced or metastatic breast cancer.


ADVENTRX PHARMACEUTICALS, Inc.
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Brian M. Culley, Chief Executive Officer of ADVENTRX told investors via a press release that the Exelbine submission included twelve months of site-specific stability data from the company's intended commercial manufacturer, which fulfills a request communicated to the company by the FDA earlier this year.

"We believe this submission will be accepted for review in early 2011 and we look forward to working with the Agency toward our first product approval," said Culley.

In October 2010, patent claims related to Exelbine were allowed by the United States Patent and Trademark Office. When they are finally issued, the claims should extend into 2024. The company retains exclusive worldwide rights to Exelbine, other than in China, Hong Kong, Macau and Taiwan.

Exelbine is set to target the same indications as Navelbine®, a branded formulation of vinorelbine, including non-small cell lung cancer.





Read the full report: adventrx-pharmaceuticals-incamex-anx | biotech-news | stock-tips

puppibaluppi 03-11-10 23:55

dsco
 
Amico Calopre cosa ne pensi di discovery lab a questi prezzi? il prox 9 novembre è schedulata una cc per discutere dei risultati dei test richiesti dalla FDA e mi sembra un appuntamento epicale per la società Tu come la vedi? Grazie

calopre 04-11-10 00:09

Citazione:

Originalmente inviato da puppibaluppi (Messaggio 27033285)
Amico Calopre cosa ne pensi di discovery lab a questi prezzi? il prox 9 novembre è schedulata una cc per discutere dei risultati dei test richiesti dalla FDA e mi sembra un appuntamento epicale per la società Tu come la vedi? Grazie

l'andamento in borsa non ha mostrato nessuna fiducia verso il titolo ed anche io è un pezzo che non lo seguo guardandolo ogni tanto per richieste simili alla tua. se sei dentro mantieni almeno potrai godere di eventuali vantaggi derivanti da notizie positive. ma se devi entrarci c'è sicuramente di meglio.

fish782000 04-11-10 11:38

Citazione:

Originalmente inviato da calopre (Messaggio 27033370)
l'andamento in borsa non ha mostrato nessuna fiducia verso il titolo ed anche io è un pezzo che non lo seguo guardandolo ogni tanto per richieste simili alla tua. se sei dentro mantieni almeno potrai godere di eventuali vantaggi derivanti da notizie positive. ma se devi entrarci c'è sicuramente di meglio.

ma in un momento come adesso cosa puo' esserci che bolle ed è in attesa di risposte da fda?

io sono in cxm, sppi, snss e ctic ma non sono convinto....

qcosa a breve??
grazie

calopre 04-11-10 12:29

Orphan drug designation granted to Discovery Laboratories' KL4 surfactant


Read the full report: orphan-drug-designation-granted-to-discovery-laboratories-kl4-surfactant | biotech-news | stock-tips

calopre 04-11-10 17:40

mio portafoglio
ANX
PDLI
HEB
CVM
REPROS THERAPEUTICS
ho lascato perdere RGN per il rischio OTC ma mipiace.
vediamole una per una
ANX ferma da mesi sui 2 dollari,dà buone notizie di se e nel 2011 concludere positivamente la sua pipeline.
PDLI è un colosso del pharma e quota ai minimi.
HEB, AMPLIGEN dovrebbe essere il farmaco del 2011 grande potenziale.
CVM la nuova exas
REpros aspettiamo il 9/11 per saperne di più.FDA Grants Type B Meeting to Be Held November 8, 2010 to Discuss Phase III Protocols for Androxal
mi sa che mi sono esposto troppo. comunque vedremo

calopre 04-11-10 17:54

quello che è già successo e quello che deve succedere
4Q 2010 Catalysts with no specific date announced. Click on individual months ABOVE for catalysts (eg PDUFAs) with definitive dates
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Google Finance Live price Catalyst Notes - Click for details
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AEZS 1.24 Data Ph2 Ovarian Cancer HALO 7.63 Data Ph2 Type 1 Diabetes
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AEZS 1.24 Complete Ph3 Adult Growth Deficiency 4Q '10, File NDA '11 ISTA 4.03 Initiate Ph2 bepotastine besilate nasal spray
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AEZS 1.24 Initiate Ph2 Bladder cancer 2H '10 KERX 5.44 Short term efficacy data due for Zerenex
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AIS 1.39 File NDA overactive bladder late 2010 LXRX 1.66 Data Ph2 RA + autoimmune diseases
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ANX 2.11 Refile NDA Cancer - NSCLC MNOV 5.01 Complete opioid withdrawl Ph 1/2a
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ASTM 2.51 Data Ph2 Stem - Dilated Cardiomyopathy MYRX 3.58 Initiate Ph 2b glioblastoma in 4Q
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BCRX 5.03 Data Ph2 Gout - UPDATE - RELEASED NBIX 7.58 Initiate Ph2a Tardive Dyskinesia
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BNVID 0.93 Initiate Ph3 for hot flashes 2H NLTX 0.68 Data Ph2 ADHF 4Q
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BPAX 1.48 Initiate Ph2 Prostate Cancer vaccine OPTR 9.62 Plan NDA filing for Clostridium difficile infection
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CAPS 0.91 Data Ph2 keloid scarring PATH 5.43 File NDA late 2010 for migraine
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CHTP 4.88 Initiate Ph2 Rheumatoid Arthritis Oct POZN 6.60 Phase 3 FDA mtg December 2010
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CORT 3.66 Data December Ph3 Cushing's PPCO 3.10 Complete Ph2a MELAS 4Q 2010
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CTIC 0.39 Estimated initiation of Ph3 NHL with poss SPA PPCO 3.10 Complete Ph2a Friedreich’s Ataxia 4Q 2010
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CYCC 1.60 Data Ph2 myelodysplastic syndromes PPCO 3.10 Data Ph2 MELAS
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CYCC 1.60 Commence Ph3 AML PPCO 3.10 Data Ph2 Friedreich’s Ataxia
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CYCC 1.60 Data Ph2 NSCLC 2H '10 PPHM 1.64 Ph2 Glioblastoma interim data Oct 18


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CYCC 1.60 Data Ph2b NSCLC 2H '10 PTIE 8.76 Refile NDA Pain - Moderate/severe chronic
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CYTK 2.53 Data Ph2a Amyotrophic lateral sclerosis 2H '10 PTN 1.35 Meet FDA re Ph2 Erectile Dysfunction protocol
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DARA 2.25 Initiate Ph2b Neuropathic Pain 2H '10 SCMP 3.45 Topline Data Ph3 Safety Chronic constipation
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DCTH 8.28 NDA filing melanoma SCMP 3.45 Initiate Ph3 opioid-induced bowel dysfunction
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DRRX 2.64 NDA resubmit Chronic pain SNSS 3.69 Data Ph2 NSCLC 4Q or 1Q '11
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EURX 10.92 Initiate Ph2 Nausea and vomiting SNTA 0.31 Initiate Ph3 AML 4Q 2010
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FOLD 4.28 Initiate Ph2 Fabry Disease SPPI 4.56 Submit data following CRL for Fusilev
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IMGN 7.88 Decision on initiation of pivotal Merkel cell carcinoma trial end 2010 THRX 20.43 Topline Ph2 PUMA data due late 2010
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IMMU 3.89 Initiate Ph3 lupus 2H VICL 2.16 Data Ph3 Ischemia
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INCY 16.16 Initiate Ph3 Polycythemia Vera VPHM 16.99 Prelim data Subcutaneous Delivery of Cinryze late 2010
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INCY 16.16 Data Ph3 Myelofibrosis due December VVUS 6.97 Open label Erectile Dysfunction due late 2010
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INCY 16.16 Data Ph2a Rheumatoid Arthritis November
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INHX 2.00 Data top line Ph2 Shingles

dimenticavo che fa parte del portfolio anche bionovo, un pharma non chimico ma che si avvale di prodotti naturali. sembra sulla buona strada.Menerba® for the Treatment of Vasomotor Symptoms (Hot Flashes) Associated with Menopause

Background

puppibaluppi 04-11-10 18:59

grazie per la risposta..so che dsco annuncerà con una c.c. il 9 novembre i risultati clinici della III fase per farmaco sufacsin.... non potrebbe essere una buona occasione?

calopre 05-11-10 00:34

riportato da altro forum
ANX ha presentato NDA per Exelbine... FDA entro il 2 di gennaio dovrebbe accettare o meno la domanda... ANX la sottopone come 505 (b)(2) basata su uno studio di bioequivalenza con Navelbine. scelta tanto rischiosa quanto potenzialmente remunerativa, per chi fosse interessato.

RW1392 05-11-10 00:40

Citazione:

Originalmente inviato da calopre (Messaggio 27043396)
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BPAX 1.48 Initiate Ph2 Prostate Cancer vaccine OPTR 9.62 Plan NDA filing for Clostridium difficile infection
.

http://www.finanzaonline.com/forum/w...ls-inc-12.html

Io ho in testa un range definito ( appena sopra $ 2.00) anche se ci sono obiettivi di prezzo ben superiori, in area $ 2.70 circa. Che ne pensi Calopre ?

Ciao

calopre 05-11-10 10:22

Citazione:

Originalmente inviato da RW1392 (Messaggio 27047589)
http://www.finanzaonline.com/forum/w...ls-inc-12.html

Io ho in testa un range definito ( appena sopra $ 2.00) anche se ci sono obiettivi di prezzo ben superiori, in area $ 2.70 circa. Che ne pensi Calopre ?

Ciao

se non va nel dimenticatoio,1,80- 2,è possibile.
le notizie per oggi
MannKind shares rocked on alleged scandel. After the bell: Jazz soars on strong earnings


Read the full report: rxnews-recap-for-11-04-10 | biotech-news | stock-tips

calopre 05-11-10 17:41

PDL BioPharma Completes Exchange to Retire $92.0 Million of 2.00% Convertible Notes Due


Read the full report: http://biomedreports.com/2010110559557/pdl-biopharma-completes-exchange-to-retire-$92.0-million-of-2.00-convertible-notes-due-august-2012.html#ixzz14QX8Ww2M

calopre 05-11-10 18:00

Earnings announcement (HEB)
Data: lunedì, 8 novembre 2010

calopre 06-11-10 13:18

dalle 18 di ieri ad ora ricacciato indietro da quattro pagine e mezzo di nuovi titoli quanella normalità delle discussioni si arretrava di non più di una pagina.
mi fa piacere che ci siano tanti utenti ma approfondimenti pochi, mi sa che ognuno lancia il titolo che ha in portfolio o ne cerca notizie.
oppure è la borsa con le sue incertezze e le sue speranze che provoca l'interessamento per un così vasto giardinetto titoli.per cui concentriamoci su quei pochi titoli che possono creare valore e teniamoli in caso contrario si entra in un vorticr di compravendite senza costrutto e con perdite sicure. a lunedì

il-parigino7 06-11-10 13:52

i prossimi appuntamenti sppi cycc gnbt? grazie

calopre 06-11-10 17:23

Citazione:

Originalmente inviato da il-parigino7 (Messaggio 27062937)
i prossimi appuntamenti sppi cycc gnbt? grazie

ah.... sapere cosa riserva il futuro a questi e altri titoli!
cycc in movimento
sppi è sempre stato un mistero per me,non capisco la strategia.potrebbevalere tanto o fare la fine di una ciofeca.
gnbt.....le bibite boom non vanno.
eventuali notizie le trovi a questo sito
FDA committe supports Pozen trial. Somaxon shares surge ahead of earnings


Read the full report: rxnews-recap-for-11-05-10 | biotech-news | stock-tips

calopre 06-11-10 17:31

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SPPI 4.41 Belinostat Cancer - Carcinoma Phase 2 Complete enrolment 2010 11/4/2010
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SPPI 4.41 Fusilev Cancer - Colorectal sNDA CRL - refiled sNDA Nov 1, 2010 11/2/2010
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SPPI 4.41 Apaziquone Cancer - Bladder Phase 3 Topline data 2012 11/4/2010
.
S

calopre 06-11-10 17:43

.
PDLI 5.62 Teplizumab Diabetes Phase 3
.
PDLI 5.62 Solanezumab Alzheimer’s Phase 3
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PDLI 5.62 Bapineuzumab Alzheimer’s Phase 3 Data 2012
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PDLI 5.62 Lucentis RVO sBLA Approved in EU Oct 22 '10 <also approved in US> PDLI get 3% royalties 10/22/2010
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PDLI 5.62 Lucentis DME Phase 3
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PDLI 5.62 trastuzumab-DM1 Cancer - Breast HER2+ Phase 3 First-line trial start mid 2010
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PDLI 5.62 trastuzumab-DM1 Cancer - Breast HER2+ Phase 3 Second-line ongoing
.
PDLI 5.62 trastuzumab-DM1 Cancer - Breast HER2+ Phase 2 Third-line - BLA filed 2010 poss
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PDLI 5.62 Avastin Cancer - Ovarian Phase 3 Completed
.
PDLI 5.62 Avastin Cancer - Gastric Phase 3 Endpoint not met
.
PDLI 5.62 Avastin Cancer - Prostate Phase 3 Endpoint not met
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PDLI 5.62 Avastin + docetaxel chemo Cancer - Metatastic Breast sNDA PDUFA Sep 16 '10, FDA mtg Jul20 voted NO

quanto sopra per significare quale è la differenza fra due titoli e relative quotazioni
.
PGNX 4.96 RELISTOR pre-filled syringes

Wolf82 07-11-10 11:31

PDLI è molto interessante vista la pipeline..
per quanto riguarda SPPI concordo al 100% nn mi piace.. poi sul Belinostat ho fatto la tesi e ci sono 2 aziende già in fase 3..

Cmq nn dimentichiamoci HGSI con BENLYSTA (Lupus) per me potrebbe essere l'approvazione più importante di fine anno..

andreati 07-11-10 11:48

Citazione:

Originalmente inviato da Wolf82 (Messaggio 27066907)
PDLI è molto interessante vista la pipeline..
per quanto riguarda SPPI concordo al 100% nn mi piace.. poi sul Belinostat ho fatto la tesi e ci sono 2 aziende già in fase 3..

Cmq nn dimentichiamoci HGSI con BENLYSTA (Lupus) per me potrebbe essere l'approvazione più importante di fine anno..

HGSI ottimo titolo se pensiamo che 12-18 mesi fa valeva 1 dollaro. Il dubbio è che i prezzi attuali di mercato non scontino già una probabile approvazione .

Sarò incorreggibilmente ottimista e se sconcertato dagli attuali andamenti negativi dei corsi, ritengo HEB con il suo Ampligen una bella opputinità nel medio termine.

Non dimentichiamoci poi CXM visto il vasto bacino d utenza a cui potrebbe rivolgersi in caso di aprrovazione FDA.

Saluti

calopre 07-11-10 16:39

concordo in pieno, sintetiche e validissime considerazioni.
beato chi ha hgsi,primo pharma ad appassionarmi e su cui ho fatto le mie prime esperienze e purtroppo relativi errori,abbandonandolo troppo presto anche per la presunzione di prendere i guadagni e rientrare più in basso finchè non è stato troppo tardi.
è un mio errore frequente,perdo facilmente di vista a fronte di un guadagno le potenzialità del titolo,su cui mi ero convinto dopo tanti ragionamenti.
e comunque con questi titoli bisogna non avere fretta.

calopre 09-11-10 01:25

che succede, nessun contributo,tutti hanno abbandonato i pharma Mahhhhhh

aross 09-11-10 05:30

Capitano, la ciurma non abbandona la nave..almeno per ora.
Sempre dentro con qualche centinaio di avnr. Mi sto studiano i titoli amex come heb, cardium per decidermi ad entrare..

a presto
Citazione:

Originalmente inviato da calopre (Messaggio 27084991)
che succede, nessun contributo,tutti hanno abbandonato i pharma Mahhhhhh


calopre 09-11-10 11:25

studiate,studiate e date qualche buona indicazione.
oggi heb ignorata, non parlano neppure del bilancio nè della conclusioe della mega causa per la quale gli sono stati assegnati 180 milioni peraltro di difficile esigibilità, ma comunque è uscita da un incubo. comunque in cassa ancora 45 milioni.ancora di scena
Biotel soars on CardioNet buyout. Aastrom continues rally. After the bell: SciClone ups forecast



Read the full report: Biotech and Healthcare Stock Market News - BioMedReports.com

calopre 09-11-10 11:31

per gli amici di cardium
Cardium Therapeutics, Inc. Remains in Limbo as FDA Approval for Excellagen Remains Questionable
Cardium Therapeutics, Inc. Remains in Limbo as FDA Approval

calopre 09-11-10 11:35

titoli caldi per chi interessato o in plio
snts slxp endp ymi astm bmod anx azn cris

Wolf82 09-11-10 11:43

DUSA è sottovalutata..
Big Pharma : NVO e SHPGY pareri? dove possono arrivare secondo voi?

PaulHewson80 09-11-10 11:56

Citazione:

Originalmente inviato da calopre (Messaggio 27087925)
titoli caldi per chi interessato o in plio
snts slxp endp ymi astm bmod anx azn cris

Ciao Calopre,
cosa sai su ENDP e ANX?

calopre 09-11-10 16:18

Citazione:

Originalmente inviato da PaulHewson80 (Messaggio 27088243)
Ciao Calopre,
cosa sai su ENDP e ANX?

(RTTNews) - Endo Pharmaceuticals Holdings Inc. (ENDP: News ) said the U.S. FDA has informed that there is no need to convene a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review Endo's New Drug Application for the new oral formulation of long-acting oxymorphone.

FDA has also informed that it has gleaned sufficient information from previous advisory committee meetings to enable the division to reach a decision on the company's application without additional external expert input.

The new formulation of long-acting Oxymorphone designed to be crush-resistant, is a semi-synthetic opioid analgesic intended for the treatment of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

The action date set by FDA under the Prescription Drug User Fee Act is Jan. 7, 2011.
__________________
The market giveth and..the market taketh away. You cannot control the market. You can only increase your odds so that it giveth more than it taketh. Greed however, will make it taketh more than it giveth.

ADVENTRX Reports Third Quarter Financial Results
November 8, 2010 8:00 AM ET
SAN DIEGO, Nov. 8, 2010 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial results for the three and nine months ended September 30, 2010.

"Our balance sheet remains strong due to our commitment to prudent cash management and reflected $29.3 million in cash at September 30," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "We recently submitted a New Drug Application to the FDA for our lead product candidate, Exelbine, as planned, and look forward to working with the FDA toward a potential approval for Exelbine next year," continued Mr. Culley.

Third Quarter Financial Results

ADVENTRX's net loss applicable to common stock for the third quarter of 2010 was $1.8 million, or $0.13 per share, compared to net loss applicable to common stock of $2.7 million, or $0.57 per share, for the same period in 2009. Net loss applicable to common stock and net loss were the same for the three months ended September 30, 2010. Net loss applicable to common stock for the three months ended September 30, 2009 included a non-cash, deemed dividend expense of $0.4 million related to the Company's July and August 2009 equity financings.

Research and development (R&D) expenses for the third quarter of 2010 were $0.9 million, a decrease of $0.5 million, or 36%, compared to $1.4 million for the same period in 2009. The decrease was due primarily to a $1.0 million decrease in research-related manufacturing expenses for ANX-530, or Exelbine�, partially offset by a $0.3 million increase in fees for consulting services related to Exelbine and ANX-514 and a $0.2 million increase in toxicology study expenses related to Exelbine.

Selling, general and administrative (SG&A) expenses were $0.9 million for the third quarter of 2010 and for the same period in 2009.

Year-to-Date Financial Results

ADVENTRX's net loss applicable to common stock for the nine months ended September 30, 2010 was $11.8 million, or $0.94 per share, compared to net loss applicable to common stock of $9.7 million, or $2.40 per share, for the same period in 2009. Included in net loss applicable to common stock for the nine months ended September 30, 2010 and 2009 were non-cash, deemed dividend expenses of approximately $5.6 million and $1.6 million, respectively, related to the Company's January and May 2010 and June, July and August 2009 equity financings.

R&D expenses for the nine months ended September 30, 2010 were $2.8 million, a decrease of $1.8 million, or 39%, compared to $4.5 million for the same period in 2009. The decrease was due primarily to a $0.6 million decrease in external bioequivalence/clinical trial study fees and expenses largely attributable the completion of patient enrollment in the ANX-514 bioequivalence study and the completion of ANX-510 studies in the first quarter of 2009, a $0.6 million decrease in personnel costs attributable to lower headcount and the absence of severance costs in 2010, and a $0.5 million decrease in external nonclinical study fees and expenses largely attributable to a decrease in research-related manufacturing expenses for Exelbine.

SG&A expenses for the nine months ended September 30, 2010 were $3.4 million, a decrease of $0.3 million, or 9%, compared to $3.7 million for the same period in 2009. The decrease was due primarily to a $0.4 million decrease in fees for professional legal, audit and tax services, a $0.3 million decrease in personnel costs attributable to lower headcount and the absence of severance costs in 2010, and a $0.1 million decrease in the cost of the Company's facilities lease, partially offset by a $0.3 million increase in director compensation and stock compensation expense and a $0.2 million increase in fees for accounting, investor relations and commercialization consulting services.

Balance Sheet Highlights

As of September 30, 2010, the Company had cash of $29.3 million and stockholders' equity of $28.8 million.
__________________
The market giveth and..the market taketh away. You cannot control the market. You can only increase your odds so that it giveth more than it taketh. Greed however, will make it taketh more than it giveth.

Holding: DEPO

fabris2000 09-11-10 18:59

PINK:EPIX 0.0100
+0.0030 (42.86%)
Delayed: 12:30PM EST

Vol / Avg. 1.81M/95,499.00 Mkt cap 747,759.00 P/E - Div/yield - EPS -0.78

calopre 10-11-10 01:49

repros venduta situazione complessa.
peccato, ma mi fanno incazzare queste piccole pharma per l'inconpetenza, la superficialità e ladrocinio.sopravvivono per i loro stipendi KO!KO!KO!
non mi voglio convincere che è meglio 100 pdli anzichè 3500 repros.
bene speriamo adesso in ANX CVM BIONOVO e PDLI inoltre si aspettano notizie di heb ma non capisco perchè scenda continuamente forse che deve fare un doppio min intorno a 0,48.graficisti A voi la risposta.

calopre 10-11-10 10:41

Bovie Medical continues run. Genomic Health surges on earnings. Repros falls after FDA meeting


Read the full report: rxnews-recap-for-11-09-10 | biotech-news | stock-tips

Trend64 10-11-10 15:06

Citazione:

Originalmente inviato da calopre (Messaggio 27098404)
repros venduta situazione complessa.
peccato, ma mi fanno incazzare queste piccole pharma per l'inconpetenza, la superficialità e ladrocinio.sopravvivono per i loro stipendi KO!KO!KO!
non mi voglio convincere che è meglio 100 pdli anzichè 3500 repros.
bene speriamo adesso in ANX CVM BIONOVO e PDLI inoltre si aspettano notizie di heb ma non capisco perchè scenda continuamente forse che deve fare un doppio min intorno a 0,48.graficisti A voi la risposta.

Ciao Calopre ,buone news su BNVI

calopre 10-11-10 15:07

sarà come aver buttato soldi in un pozzo senza fine o alla fine ce la faranno?
PHILADELPHIA, Nov. 10, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced today grant awards totaling $488,958 from the U.S. Department of Treasury in support of its Ampligen(R) and Alferon(R) development programs. These awards were approved by the Internal Revenue Service (IRS), in conjunction with the Department of Heath and Human Services (DHHS), under the Qualifying Therapeutic Discovery Project Program, established under the Patient Protection and Affordable Care Act of 2010 for projects that showed significant potential to produce new and cost-saving therapies, support jobs and increase U.S. competitiveness. The amounts granted for these two Hemispherx projects were for the maximum per-project amount set by the IRS based on the limited amount of funds allocated for the program.



The Hemispherx Alferon(R) program grant application was based on the potential to show Alferon N Injection(R), an FDA-approved treatment for refractory HPV, and Alferon(R) LDO (low dose oral), an experimental formulation, to be an efficacious and inexpensive preventative or treatment for seasonal and pandemic flu.



The Hemispherx Ampligen(R) grant application was based on the continuing

tutte le altre pharma o quasi hanno avuto 243000$ o meno

Trend64 10-11-10 15:12

Citazione:

Originalmente inviato da Trend64 (Messaggio 27104492)
Ciao Calopre ,buone news su BNVI

1,25 in pre ,volumi comunque non elevati

calopre 10-11-10 16:28

EMERYVILLE, Calif., Nov. 10, 2010 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's total clinical development plan for Menerba, the company's drug candidate for menopausal hot flashes.


"We had a very positive meeting with the FDA on our clinical program for Menerba. As anticipated, they agreed with our overall clinical development plan which included the number of clinical trials, number of subjects and length of exposure as well as non-clinical studies necessary for New Drug Application (NDA) submission for a non-estrogen drug such as Menerba. They also provided useful suggestions for improving the clinical trial protocols," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "While we are awaiting the formal minutes from the FDA meeting, we are moving forward to implement the agency's suggestions and have forwarded the approved clinical trial design to our investigators and their investigational review boards, or IRBs."


"Menerba is a first-in-class, unique drug candidate that is intended for a large medical need, for the safe and effective treatment of menopausal symptoms," said Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "We want to do everything necessary to bring Menerba to market for the treatment of hot flashes, while we also investigate its potential use in the treatment of breast cancer prevention. Now that we have agreements with the FDA and the EMA (the European Medicines Agency) on the overall development of Menerba, we have accelerated discussions with potential partners to successfully bringing Menerba to market."

calopre 11-11-10 01:44

PDL BioPharma Announces Third Quarter 2010 Financial Results
Tools Email Print
Posted November 10, 2010

INCLINE VILLAGE, Nev., Nov. 10, 2010 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) today reported financial results for the third quarter and nine months ended September 30, 2010.

Financial Results for the Third Quarter Ended September 30, 2010

Revenues for the third quarter of 2010 were $86.4 million, a 21 percent increase when compared with $71.4 million for the same period in 2009. Revenue growth for the third quarter of 2010 over the same period in 2009 was primarily driven by increased second quarter 2010 sales by the Company's licensees of Avastin® and Herceptin®, which are marketed by Genentech and Roche; Lucentis®, which is marketed by Genentech and Novartis; and Tysabri®, which is marketed by Elan and Biogen Idec. PDL received royalties for these product sales in the third quarter of 2010.



Read more: PDL BioPharma Announces Third Quarter 2010 Financial Results - FiercePharma PDL BioPharma Announces Third Quarter 2010 Financial Results - FiercePharma
Subscribe: Pharmaceutical Newsletter, Pharma Newsletter - FiercePharma

furo 12-11-10 09:12

Ciao Calopre, sempre grazie per i tuoi interessantissimi post.
Come la vedi PARD, ha ritracciato molto ultimamente, e se non ricordo male, era un titolo che stimavi.
Grazie

calopre 12-11-10 14:41

Citazione:

Originalmente inviato da furo (Messaggio 27127489)
Ciao Calopre, sempre grazie per i tuoi interessantissimi post.
Come la vedi PARD, ha ritracciato molto ultimamente, e se non ricordo male, era un titolo che stimavi.
Grazie

picoplatin e altri fase due significa 15 mesi altri di lavoro, molte spese,attualmente quota la cassa, viaggerà attorno 0,38 - 0,70,
con input positivi al miglioramento degli studi. sempre che non imbroglino con i risultati della ricerca mi piace molto la pipeline.

calopre 17-11-10 15:53

vediamo che succede

PHILADELPHIA, Nov. 16, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders, announced today that it will present at the Maxim Group Growth Conference in New York on Thursday, November 18.

puppibaluppi 17-11-10 16:18

ciao calopre.. mi puoi dire qualcosa su arna..sta tracollando... come lo vedi? grazie

calopre 18-11-10 00:36

Citazione:

Originalmente inviato da puppibaluppi (Messaggio 27187268)
ciao calopre.. mi puoi dire qualcosa su arna..sta tracollando... come lo vedi? grazie


solo eisai la può salvare,comunque si è inimicata troppa gente e il prossimo appuntamento se non lo fallisce prima è nel 2012.regolati

furo 18-11-10 10:31

Calopre, Cosa mi dici di RGIN è nell'otc ma ha una tecnica innovativa per la pelle

alex the first 18-11-10 14:43

Ciao Calopre, come vedi siga? in pre sta facendo bene ma il target certi dicono essere a 20 cosa ne pensi, poi bsdm a questi prezzi sarebbe ancora da buy...cosa dici? grazie

calopre 18-11-10 15:40

che vi devo dire, tutti con ottime potenzialità alla pari di altri pharma,purtroppo non li seguo, devo fare delle scelte e scelgo in base a prezzo/potenzialità e al momento sto con PDLI ANX HEB CVM ed ho fatto una puntatina per un rimbalzo che non si vede su sunesit

magolibero 18-11-10 16:04

Citazione:

Originalmente inviato da furo (Messaggio 27195168)
Calopre, Cosa mi dici di RGIN è nell'otc ma ha una tecnica innovativa per la pelle

qui

http://www.finanzaonline.com/forum/o...l#post27181820

c'é qualcuno che la sta già seguendo

andreati 18-11-10 16:42

Citazione:

Originalmente inviato da calopre (Messaggio 27186704)
vediamo che succede

PHILADELPHIA, Nov. 16, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders, announced today that it will present at the Maxim Group Growth Conference in New York on Thursday, November 18.

Ma almeno oggi si nota un aumento di voluni che sepur non significativi, sono maggiori rispetto alla media delle ultime sett.
Anzi anche le quotazioni sembravano approfittarne salendo bene poi tutto rientrato. Vediamo le prossime ore se racconteranno di qualche sorpresa positiva.
.Saluti.

calopre 19-11-10 11:26

le notizie del giorno
rxnews-recap-for-11-18-10 | biotech-news | stock-tips
mi avete insegnato che su questi titoli bisogna portare pazienza, facciamolo,se ci si crede ogni ribasso è buono per accumulare vedi cvm. a lunedì

calopre 22-11-10 15:24

speriamo bene
Hemispherx Publishes New Data on Ampligen�'s Activity in

Chronic Fatigue Syndrome (CFS)

..Improves EKG parameter associated with Sudden-Onset Severe Cardiac Conditions
Philadelphia, PA - November 22, 2010 - Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the "Company"), announced the publication of a peer-reviewed article providing new data on Ampligen� [rintatolimod; poly(I )�poly(C12,U)], an experimental therapeutic in Phase III clinical testing, in the current issue of The Journal of Applied Research. The report is entitled " Cardiac Toxicity in Chronic Fatigue Syndrome (CFS): Results from a Randomized 40-Week Multicenter Double-Blind Placebo Control Trial of Rintatolimod". Findings include discussion of the sedentary lifestyle produced by extreme fatigue which is a significant risk factor for heart disease, a leading cause of death in patients with CFS. Thus, cardiac abnormalities, including abnormal electrocardiograms (EKGs), are common in CFS patients despite their relatively young age.

The AMP-516, Phase III FDA-authorized study in CFS evaluated the therapeutic effectiveness of Ampligen�, an experimental therapeutic, and included repeated measurements of the QT interval, a component of EKG testing. Prolongation of the EKG QT interval is a known risk factor in sudden cardiac death (Long QT Syndrome) due to the induction of fatal cardiac arrhythmias. A greater portion of the placebo patients were found to have a significant prolongation of the QT interval compared to patients who had received Ampligen� twice weekly. The prolonged QT interval in the placebo group was associated with continued use of certain concomitant medications, which are known to prolong the QT interval and used by CFS patients in an attempt to mitigate symptoms of the disease. In contrast, patients randomized to receive Ampligen were able to significantly reduce their dependency on these same medications.

Concomitant medications which increase the QT interval may carry a "black box" warning on their labels since prolonged QT intervals are associated with cardiac arrhythmias which may result in sudden death.

The AMP-516 study was one of the studies submitted to FDA in the Ampligen� NDA, which resulted in the previously-announced November 25, 2009 Complete Response Letter, in which FDA requested that additional data be generated and submitted on effectiveness measures and potential QT interval effects.

andreati 22-11-10 15:57

Citazione:

Originalmente inviato da calopre (Messaggio 27234529)
speriamo bene
Hemispherx Publishes New Data on Ampligen�'s Activity in

Chronic Fatigue Syndrome (CFS)

..Improves EKG parameter associated with Sudden-Onset Severe Cardiac Conditions
Philadelphia, PA - November 22, 2010 - Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the "Company"), announced the publication of a peer-reviewed article providing new data on Ampligen� [rintatolimod; poly(I )�poly(C12,U)], an experimental therapeutic in Phase III clinical testing, in the current issue of The Journal of Applied Research. The report is entitled " Cardiac Toxicity in Chronic Fatigue Syndrome (CFS): Results from a Randomized 40-Week Multicenter Double-Blind Placebo Control Trial of Rintatolimod". Findings include discussion of the sedentary lifestyle produced by extreme fatigue which is a significant risk factor for heart disease, a leading cause of death in patients with CFS. Thus, cardiac abnormalities, including abnormal electrocardiograms (EKGs), are common in CFS patients despite their relatively young age.

The AMP-516, Phase III FDA-authorized study in CFS evaluated the therapeutic effectiveness of Ampligen�, an experimental therapeutic, and included repeated measurements of the QT interval, a component of EKG testing. Prolongation of the EKG QT interval is a known risk factor in sudden cardiac death (Long QT Syndrome) due to the induction of fatal cardiac arrhythmias. A greater portion of the placebo patients were found to have a significant prolongation of the QT interval compared to patients who had received Ampligen� twice weekly. The prolonged QT interval in the placebo group was associated with continued use of certain concomitant medications, which are known to prolong the QT interval and used by CFS patients in an attempt to mitigate symptoms of the disease. In contrast, patients randomized to receive Ampligen were able to significantly reduce their dependency on these same medications.

Concomitant medications which increase the QT interval may carry a "black box" warning on their labels since prolonged QT intervals are associated with cardiac arrhythmias which may result in sudden death.

The AMP-516 study was one of the studies submitted to FDA in the Ampligen� NDA, which resulted in the previously-announced November 25, 2009 Complete Response Letter, in which FDA requested that additional data be generated and submitted on effectiveness measures and potential QT interval effects.

Ben trovato Calopre, nn sapendo tradurre nn riesco a dare un significato alla news che cmq a sensazione fonica nn mi sembra positiva.
Ringraziandoti findora tu come l hai interpretata e di cosa ci racconta?
Eppure sono convinto che siamo in una fase di sentiment per ottime prospettive.
Saluti

calopre 22-11-10 16:18

ampligen sta meglio di come stava nel 2009, ampliate le utilizzazioni,migliori riscontri attenuazione effetti collaterali. siamo sulla buona strada 70/30 diciamo al momento
sta diventando più di una scommessa. non esagerare col dosaggio

calopre 22-11-10 16:26

2011 sarà l'anno degli immunologici e quindi anche di cvm

calopre 22-11-10 17:12

CEL-SCI COMPLETES GLOBAL INVESTIGATOR MEETING IN PREPARATION FOR ENROLLMENT AND TREATMENT OF PATIENTS IN PHASE III HEAD AND NECK CANCER TRIAL

Vienna, VA, November 22, 2010 -- CEL-SCI Corporation (NYSE AMEX: CVM)
today announced that the companyheld a clinical investigator meeting during the week of November 14 for its Phase III clinical trial of Multikine®, the company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. The meeting was held in Prague, Czech Republic. More than 120 individuals from nine countries were in attendance. Attendees included clinical investigators, clinical research associates, clinical research coordinators, medical monitors, quality assurance personnel and CEL-SCI's scientific and management teams.



Clinical investigator meetings are held by clinical trial sponsors to provide protocol and Good Clinical Practice (GCP) training and allow participants an opportunity to ask questions about clinical trial conduct.



"We are excited that our meeting was met with such enthusiasm by all of the participants," said Geert Kersten, CEL-SCI's Chief Executive Officer. "We discussed best practices to ensure that the study protocol will be uniformly executed throughout the world and that GCP requirements will be strictly adhered to when enrolling and treating the research subjects. We look forward to enrolling and commencing treatment of the first subject in our global Phase III clinical trial of Multikine soon."



CEL-SCI's Phase III clinical trial is an open-label, randomized, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall survival rate versus the subjects treated with standard of care only. North Mississippi Health Services was the first site in the United States to approve enrollment of subjects.



CEL-SCI's trial will be conducted in nine countries and is expected to be the largest clinical study of head and neck cancer ever conducted. It will be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted.



Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in Phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration gave clearance for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.

andreati 22-11-10 17:39

Citazione:

Originalmente inviato da calopre (Messaggio 27235588)
ampligen sta meglio di come stava nel 2009, ampliate le utilizzazioni,migliori riscontri attenuazione effetti collaterali. siamo sulla buona strada 70/30 diciamo al momento
sta diventando più di una scommessa. non esagerare col dosaggio

Certo la tentazione ci sarebbe:
- riduzione degli effetti collaterali o per lo meno miglior controllo dei medesimi cosa che era stato motivo del precedente rinvio del dicembre09

- ampliamento della usabilità anche se già i pazienti di CFS negli USA e in Europa sono statisticamente rilevanti

- liquidità per portare avanti il pòrocesso di ricerca e testing a mio avviso sufficente per arrivare in fondo con scarsa probabilità quindi di ADC

Rimane il grosso dubbio sui tempi e sulle òprocedure di pronuncia da parte di FDA che prolungandosi oltre il previsto atteso potrebbero gettare sul titolo sia gli shortisti sia congetture di nn approvazione.
Saluti

exfumatore68 22-11-10 19:14

Citazione:

Originalmente inviato da andreati (Messaggio 27237132)
Certo la tentazione ci sarebbe:
- riduzione degli effetti collaterali o per lo meno miglior controllo dei medesimi cosa che era stato motivo del precedente rinvio del dicembre09

- ampliamento della usabilità anche se già i pazienti di CFS negli USA e in Europa sono statisticamente rilevanti

- liquidità per portare avanti il pòrocesso di ricerca e testing a mio avviso sufficente per arrivare in fondo con scarsa probabilità quindi di ADC

Rimane il grosso dubbio sui tempi e sulle òprocedure di pronuncia da parte di FDA che prolungandosi oltre il previsto atteso potrebbero gettare sul titolo sia gli shortisti sia congetture di nn approvazione.
Saluti

Seguo heb ormai da 2 anni; il punto critico è che nella CRL del dicembre 2009 , la FDA ha chiesto un ultriore trial della durata di almeno 6 mesi e su un campione di 300 pazienti in grado di provare l'efficacia di Ampligen. Successivamente sono emerse importanti novità sul retrovirus XMRV che intersserebbe i malati cfs; per cui ora la società sta cercando di ottenere i consensi dalla comunità scientifica sulla efficacia di Ampligen contro il retovirus, per poi incontrare a breve la FDA, con nuovi dati alla mano, e chiedere una revisione meno onerosa del trial aggiuntivo richiesto inizialmente.
Prevedendo un incontro con la FDA a gennaio 2011 ritengo che non prima della fine del 2011 potremo avere una nuova data per PDUFA.
Certo qualcosa inizia a muoversi dopo 1 anno di silenzio castigato!!!

calopre 24-11-10 14:21

per chi interessato
gli appuntamenti di dicembre

calopre 24-11-10 14:23

per chi interessato
gli appuntamenti di dicembre
Mercoledì, 24 Novembre 2010
Vista Mensile Dicembre 2010

2
BMY
4
ASH Annual Meet ...
CYCC
5
ASH Annual Meet ...

49 6
ASH Annual Meet ...
7
ASH Annual Meet ...
OREX
PCYC
8
MKGAY
NVLT
9
HGSI
10
CPIX
11
16
AZN

25
BMY
26
LCI

29
ALIM
MNKD
30
31

calopre 30-11-10 12:52

si allunga il brodo,evidentemente i risultati non sono ancora validi.
Hemispherx Biopharma Files With the FDA a Request to Maintain as Active Hemispherx NDA for Ampligen(R) to Treat Chronic Fatigue Syndrome (CFS
12 mesi altri per nda
oppure non vogliono sbagliare il colpo e vogliono acquisire ulteriori dati per andare sul sicuro.

calopre 30-11-10 15:57

le ultime
rxnews-recap-for-11-29-10 | biotech-news | stock-tips

exfumatore68 30-11-10 16:40

Citazione:

Originalmente inviato da calopre (Messaggio 27325018)
si allunga il brodo,evidentemente i risultati non sono ancora validi.
Hemispherx Biopharma Files With the FDA a Request to Maintain as Active Hemispherx NDA for Ampligen(R) to Treat Chronic Fatigue Syndrome (CFS
12 mesi altri per nda
oppure non vogliono sbagliare il colpo e vogliono acquisire ulteriori dati per andare sul sicuro.

Non è che i dati non sono validi e che vanno rideterminati alla luce del retrovirus XMRV e previo incontro con la FDA. Semplicemente non vogliono buttare all'aria i risultati precedenti già presentati all' FDA e vogliono che questi tenga aperta la domanda a suo tempo presentata dalla società. Tutto quà quindi i tempi sono abbasatanza lunghi al momento forse più di 1 anno.

cityhunter 30-11-10 19:00

Aggiungerei 29 dicembre psdv... o è stato spostato?
[QUOTE=calopre;27261392]per chi interessato
gli appuntamenti di dicembre
Mercoledì, 24 Novembre 2010
Vista Mensile Dicembre 2010

calopre 30-11-10 19:12

PSDV 29 Dicembre

calopre 01-12-10 13:12

le nuove di oggi
rxnews-recap-for-11-30-10 | biotech-news | stock-tips
occhio a cvm

calopre 01-12-10 19:23

Attenzione a HEB dopo questo rinvio di 12 mesi potrebbe andare a 0,25,vediamo cosa succede magari lo riprendiamo la prossima estate.

calopre 09-12-10 17:16

organizzatevi un bel 2011,siete ancora in tempo
CXM,un pharma pregiato con una pipeline fuori dagli schemi.
CVM, tutti aspettano il suo pharma, si sta organizzando bene,potrebbe aver bisogno di maggiore liquidità,rientrare massicciamente e definitivamente su eventuale ritracciamento.

dimenticavo, exas, a questi prezzi sono rientrato,se posso accumulo e non si esce più fino al valore finale nel 2012

RW1392 09-12-10 18:01

1 Allegato/i
Ciao Calopre. La tua valutazione su BNVI e' rimasta quella di tempo fa ? Oggi su tenuta di area $ 1.20 offre un ingresso per i ritardatari.

Citazione:

Originalmente inviato da calopre (Messaggio 27339066)
occhio a cvm

L'ho aggiornata in queste ultime sedute.
Anche PDLI con un passo regolare, si e' apprezzata di un $ dall'ultimo gap down

http://www.finanzaonline.com/forum/2...8-post248.html

Il giornaliero in formazione

calopre 09-12-10 18:42

Citazione:

Originalmente inviato da RW1392 (Messaggio 27418877)
Ciao Calopre. La tua valutazione su BNVI e' rimasta quella di tempo fa ? Oggi su tenuta di area $ 1.20 offre un ingresso per i ritardatari.



L'ho aggiornata in queste ultime sedute.
Anche PDLI con un passo regolare, si e' apprezzata di un $ dall'ultimo gap down

http://www.finanzaonline.com/forum/2...8-post248.html

Il giornaliero in formazione

tante bio,tanta dispersione,mi sono accorto di non poter seguire tutti gli input dei titoli peraltro validi come quelli da te segnalati. ho ristretto il campo,considerate le varie approvazioni,i settori dove avvengono più facilmente e dove invece sembrano presentarsi difficoltà insormontabili, valutati i prezzi e considerato che voglio un pò staccare e fare un investimento più sul lungo termine anche se per cxm mi aspetto qwualcosa a breve, ho ritenuto validi e ho scelto di puntare su questi titoli
cxm, cvm, exas, sotto osservazione heb anche se giorno dopo giorno dimostra di non avere un management di valore come quello delle tre anzidette.
in bocca al lupo per le vostre scelte.

calopre 10-12-10 19:38

Citazione:

Originalmente inviato da calopre (Messaggio 27419327)
tante bio,tanta dispersione,mi sono accorto di non poter seguire tutti gli input dei titoli peraltro validi come quelli da te segnalati. ho ristretto il campo,considerate le varie approvazioni,i settori dove avvengono più facilmente e dove invece sembrano presentarsi difficoltà insormontabili, valutati i prezzi e considerato che voglio un pò staccare e fare un investimento più sul lungo termine anche se per cxm mi aspetto qwualcosa a breve, ho ritenuto validi e ho scelto di puntare su questi titoli
cxm, cvm, exas, sotto osservazione heb anche se giorno dopo giorno dimostra di non avere un management di valore come quello delle tre anzidette.
in bocca al lupo per le vostre scelte.

nota: menerba mi piace ancora

furo 29-12-10 14:36

non uppa piu nessuno???
Calopre devoe sei finito??
ferie??

the volture 10-01-11 18:52

2 Allegato/i
oggi news di una fase 2 credo...PPHM: Summary for Peregrine Pharmaceuticals Inc.- Yahoo! Finance


oggi scambia 1/3 del totale dell'altra settimana completo

furo 02-02-11 16:05

non si scrive piu su sto forum?
Era interessante....

calopre 17-04-11 18:45

ripartiamo da cxm

RW1392 18-04-11 13:00

5 Allegato/i
Citazione:

Originalmente inviato da furo (Messaggio 27971366)
non si scrive piu su sto forum?
Era interessante....

Posto alcuni grafici, di titoli che sono seguiti nei rispettivi topic.
Io, sono direttamente interessato solo su ZLCS ma sto seguendo anche bnvi, cvm, somx, sppi, exas ...

andreati 20-04-11 15:04

Citazione:

Originalmente inviato da calopre (Messaggio 28814839)
ripartiamo da cxm

Intanto comportamento strano quello di ieri di cxm che nelle prime due ore e mezza è arrivata a perdere quasi il 7 con 450000 azioni scambniate e nelle restanti 4 ore ne ha scambiate solo 100000 recuperando durante per poi perdere con piccoli scambi. Chissà hanno venduto o comprato con forza relativa in attesa di news imminenti?
Per heb invecesilenzio i prospettive congelate a nuovi eventi o informazioni
che tardano ad arrivare facendo galleggiare le quotazioni in modo abulico e senza direzionalità.
Saluti

mazzam 22-05-11 19:45

Asco 2011
 
http://chicago2011.asco.org/LinkClic...%3D&tabid=1190
(ultime pagine)

chi c'è c'è, chi non c'è non credo ci sarà....

no kerx :eek:
no aezs :eek:
no rosg :eek:

si cticd :rolleyes: :D :p
si sppi :specchio:
si ymi :D
si immu :wall: :D
si pphm :fiufiu:
.......

mikiass 22-05-11 21:56

Citazione:

Originalmente inviato da mazzam (Messaggio 29156356)
http://chicago2011.asco.org/linkclic...%3d&tabid=1190
(ultime pagine)

chi c'è c'è, chi non c'è non credo ci sarà....

No kerx :eek:
No aezs :eek:
No rosg :eek:

Si cticd :rolleyes: :d :p
si sppi :specchio:
Si ymi :d
si immu :wall: :d
si pphm :fiufiu:
.......

gnta

miami vice 24-05-11 10:38

ciao a tutti!
qualcuno segue per caso JIANGBO PHARMA DOLLARI (JGBO) ?


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