Titoli con farmaco in approvazione 3

[pansotti]

che dite di INCY ?

[mossetto]

sunesis ppharmaceuticals ... sperem :

Il gruppo biotecnologico produce un farmaco che aumentera' le probabilita' di sopravvivenza delle persone che soffrono di AML, una fomra particolarmente grave di leucemia. I titoli potrebbero di conseguenza quasi triplicare dai livelli attuali. Il mercato dell'AML vale circa $900 milioni l'anno. Se il farmaco dovessere essere approvato, le stime piu' conservative vogliono che SNSS ottenga un terzo dell'intera quota a disposizione. Mettiamo che i margini lordi siano del 50%, che le spese operative siano pari a $50 milioni l'anno - tutte stime molto conservative - e che i flussi di cassa operativi l'anno scorso siano stati pari a 22 milioni. Questo porterebbe ad un reddito operativo di circa $100 milioni. Se si applica un un rapporto tra prezzo di Borsa e valore effettivo di 20 volte, che pure e' una stima conservativa se si tiene conto che le altre biotech come GENZ hanno un rapporto P/E pari a 34 volte, allora si ottiene un capitale di mercato potenziale di $2 miliardi, ovvero un titolo da $10. Facciamo finta che ci sia solo una possibilita' del 50% che la Fda approvi il farmaco, anche se le probabilita' sono a tutti gli effetti piu' alte. Il gruppo tra l'altro non ha avuto che risposte positive dalla FDA nella sua storia. Alla fine abbiamo un prezzo stimato di $5 ento il 2012-13, ovvero quando si prevede che i test siano completati e le vendite siano pronte a partire. Proviamo ad andare indietro un paio di anni, sottraendo dunque un buon 20% e otteniamo un target price di $3.

[esko]

qualcuno ha le prossime date fda? tks

[calopre]

Prana Biotechnology soars on Alzheimer's trial data. Cadence re-submits NDA. After the bell, Array BioPharma flys on Novartis agreement PDF | Print | E-mail
Written by BioMedReports.com Staff
Monday, 19 April 2010 16:26
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Below is a list of the companies that made news in the healthcare sector on Monday, April 19, 2010.
Prana Biotechnology (NASDAQ:PRAN) (ASX:PBT) soared today after the company announced that the authoritative scientific journal, Journal of Alzheimer's Disease, published an article on April 19 about Prana's lead drug candidate for Alzheimer's disease, PBT2, providing new analysis that it is effective in reversing dementia symptoms. The analysis, conducted by Professor Ashley Bush of The Mental Health Research Institute and The University of Melbourne, Australia, is based on tracking and ranking the responses of each individual patient, rather than only groups of patients, in Prana's PBT2's Phase IIa Alzheimer's disease clinical trial.

The results of the Phase IIa clinical trial, previously reported in The Lancet Neurology (July 2008 and an erratum in July 2009), showed that patients with mild Alzheimer's Disease treated with 250mg of PBT2, experienced an overall statistically significant improvement in Executive Function on a Neuropsychological Test Battery (NTB) within 12 weeks of treatment.

"Improvements in Executive Function is strongly related to improvement in daily function and to the quality of the daily life of patients," noted Dr. Jeffrey Cummings, Director, Alzheimer Disease Research Center, UCLA, and Chairman of Prana's Scientific Advisory Board.

"Very few drugs in clinical development have been able to bring these benefits to Alzheimer's Disease patients. I am very encouraged by these findings," concluded Dr. Cummings.

The Journal of Alzheimer's Disease paper reports the results of a post-unblinding analysis of the cognitive data that was not included in the original paper. The objective of the analysis was to see how individual patients who were receiving PBT2 responded compared to the individual patients who only received placebo. Importantly, even placebo patients showed some improvement in the tests because of a 'learning effect' of repeated testing. This new analysis has adjusted for this and demonstrated that: 1) 81% of patients on the 250mg dose of PBT2 responded better on the Executive Factor NTB score than the best performing patient on placebo. 2) 41% of patients on the 250mg dose of PBT2 responded better on the overall Composite NTB score than the best performing patient on placebo.

Shares of Prana raced higher, surging $1.06 or 78.52%, closing the day at $2.41.

Cadence Pharmaceuticals, Inc. (Nasdaq:CADX) moved higher today after the company announced that, based on feedback received during a meeting with the U.S. Food and Drug Administration (FDA) on April 16, 2010, it plans to re-submit a New Drug Application (NDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, within the next 30 days.

The April 16 meeting was a Type A meeting held among the FDA, Cadence, and its third party manufacturer to discuss the deficiencies outlined in the Complete Response letter related to an inspection of the facility used to manufacture OFIRMEV.

"We believe that last week's meeting with FDA was an important step forward to address the observations from the FDA's inspection of our third party manufacturer's facility and move toward potential approval of OFIRMEV," stated Ted Schroeder, President and CEO. "Based upon our discussions with the agency, we believe that it is appropriate to promptly resubmit the NDA for OFIRMEV and intend do so within the next 30 days."

At the meeting, the FDA did not request any additional information related to the NDA, including any new stability studies. The agency will determine the type of resubmission (Class 1 or Class 2) and resulting review timeline (two months or six months, respectively) after the NDA is resubmitted. Cadence will continue to work with its third party manufacturer to ensure that the observations from the FDA's inspection of the manufacturing facility for OFIRMEV are resolved in a timely manner.

Shares jumped more than 13% or $1.26, closing the day at $10.45.

Array BioPharma Inc. (Nasdaq: ARRY) flew after the bell today after the company announced that it has entered into an agreement with Novartis for the worldwide development of the small-molecule MEK inhibitors ARRY-162, currently in a Phase 1 cancer trial, its back-up, ARRY-300, and other MEK inhibitors.

Under the terms of the agreement, Array will initially receive $45 million comprising an upfront and milestone payment and is eligible to receive an additional $422 million if certain clinical, regulatory and commercial milestones are achieved. In addition, Array plans to co-develop ARRY-162 in one or more specific indications and fund a portion of development costs. The agreement provides Array with double-digit royalties on sales of approved drugs outside of the U.S., with a significantly higher royalty rate for U.S. sales provided that Array meets its co-funding obligations. Array also has a co-detailing right in the U.S. for approved drugs.

"This agreement with Novartis is a major advance in our strategic objective to become a fully integrated, commercial-stage biopharmaceutical company," said Robert E. Conway, Chief Executive Officer, Array BioPharma. "We believe ARRY-162 will benefit from the additional resources of a major pharmaceutical company to rapidly maximize its promise as a cancer treatment, both as a single agent and in combination therapy. Novartis is the right partner because of its track record in developing and commercializing important new cancer therapies."

Shares of Array were up more than 33% as more than 1 Million shares were traded in the after hours market. After closing the regular session at $3.02, shares touched $4.79 in the after market before settling at $4.03.

In other news after the market closed:

Amgen (Nasdaq:AMGN) announced results of a preclinical study demonstrating a positive response to administration of RANK-Fc against mammary tumor formation in mouse models. OPG-Fc and RANK-Fc bind to and block the action of RANKL. These molecules have a comparable mechanism of action to denosumab.

ICU Medical, Inc., (Nasdaq:ICUI), a leading low cost manufacturer of safe medical connectors, custom medical products and critical care devices, announced results for the first quarter ended March 31, 2010.

First quarter of 2010 revenue increased 18.5% to $64.4 million, compared to $54.3 million in the same period last year. Net income for the first quarter of 2010 was $4.3 million, or $0.30 per diluted share, as compared to net income of $7.1 million, or $0.47 per diluted share, for the first quarter of 2009.

Scott Lamb, ICU Medical's Chief Financial Officer, said, "We are pleased with our top-line growth during the quarter, which was driven by strong performance of CLAVEs, Custom Sets and critical care. Domestic distributor and direct sales were up 184% and international sales increased 53% year over year."

CombiMatrix Corporation (Nasdaq:CBMX) announced after the bell today that it is implementing a restructuring plan to significantly reduce operating costs, increase the focus on the Company's diagnostic services business and transition senior management. After the restructuring, CombiMatrix will be focused on its diagnostics services business, including increasing utilization of its existing tests, expanding the test menu, increasing the number of customers and partners, and improving reimbursement for its testing services. Management and operations at CombiMatrix's diagnostic laboratory in Irvine, CA will not be affected by this restructuring. Specific components of the plan and additional details will be presented at the company's second quarter earnings call scheduled for May 11, 2010, if not sooner.

XOMA Ltd. (Nasdaq:XOMA), presented results showing that XOMA's antibody to interleukin-1 beta (IL-1 beta), XOMA 052, was highly effective in reducing production of a protein that supports the proliferation of cancerous human myeloma cells in vitro. These results are consistent with a 47 patient clinical trial in early-stage myeloma patients which demonstrated that IL-1 blockade with IL-1 receptor antagonist Kineret(R) (anakinra) in combination with standard therapy improved progression-free survival..

In news from earlier in the day:

Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) soared ahead of its April 22, 2010 FDA Advisory Committee meeting to discuss the New Drug Application ("NDA") for Acurox(R) (oxycodone HCl and niacin) Tablets and the results of studies evaluating the addition of niacin for the purpose of reducing the misuse of oxycodone. The scheduled meeting will be a joint meeting of the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees. Acurox(R) is an investigational new drug product and is not approved for marketing or commercial distribution. Shares were up more than 34% on the day, surging $2.04 to $7.91.

Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) today reported financial results for the quarter ended March 31, 2010. The Company reported total revenue of $174.1 million for the quarter ended March 31, 2010, which includes net product sales of $172.3 million. Non-GAAP operating loss was $3.8 million for the quarter ended March 31, 2010, compared to $19.9 million for the same period in 2009. GAAP net loss was $38.2 million, or $0.27 per share, for the quarter ended March 31, 2010, compared to $47.0 million, or $0.34 per share, for the same period in 2009. At March 31, 2010 the Company held cash, cash equivalents and short-term investments of $598.3 million. "With the submission of our BYDUREON response this week, we are preparing to make this revolutionary treatment option available this year to the millions of patients living with type 2 diabetes," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "We remain focused on driving revenue from our currently marketed products, BYETTA and SYMLIN, and continue to exercise financial discipline so that we remain on track to generate sustainable positive operating cash flow by year end."

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that Firdapse™ (3,4-diaminopyridine) is now commercially available in the European Union (E.U.) for the treatment of the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS). Launching immediately in Germany and the UK, the company expects to subsequently launch Firdapse in all major European markets by the end of 2010. Firdapse received marketing approval in the E.U. for the treatment of LEMS in December 2009 and is the first approved treatment for this indication, thereby conferring orphan drug protection and providing ten years of market exclusivity in Europe.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) will present and separately participate in a cancer immunotherapy panel discussion at the World Vaccine Congress, which will take place April 19-22 in Washington, D.C.

Boston Scientific Corporation (NYSE:BSX) today announced that it has entered into a four-year exclusive marketing agreement with Bladder Health Network (BHN), a privately held company offering advanced testing solutions for urinary incontinence. BHN offers an integrated diagnostic solutions platform that combines software, staffing, equipment, supplies and results analysis, providing physicians and their patients with greater access to testing, interpretation and treatment options for urinary incontinence and other problems related to the urinary system.

Celldex Therapeutics, Inc. (Nasdaq: CLDX), an antibody-based combination immunotherapy company, today announced that CDX-1127, a preclinical therapeutic antibody program for oncology indications, will be the subject of a poster presentation at the 2010 American Association for Cancer Research (AACR) 101st Annual Meeting in Washington, DC on Wednesday, April 21, 2010.

Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it met with and received feedback from the rapporteurs and the European Medicines Agency's medical reviewers regarding a proposed filing of a Marketing Authorization Application for pixantrone in the European Union to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. The rapporteurs, who are assigned by the EMEA, are responsible for providing scientific advice on the evaluation of medicinal products. The feedback was supportive of filing on the basis of the PIX301 trial and the Company expects to submit the MAA in September 2010. "Both the rapporteurs and medical reviewers felt that the totality of the efficacy data from the PIX301 trial including the complete response rate, overall response rate, progression-free survival and the trend in overall survival supports a MAA submission and review," said Jack Singer, M.D., Chief Medical Officer of the Company.

Cord Blood America, Inc. (OTC Bulletin Board:CBAI.ob), 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, today announced that it has signed a Letter of Intent to purchase controlling interest in BioCells, Inc., headquartered in Argentina, with affiliates under development in Peru, Colombia, Bolivia, Panama and Puerto Rico.

BioCells, the second largest stem cell storage company in Argentina, is profitable, with annual revenues in 2009 of $1.2 million (USD), and 12 locations throughout that country, plus recent expansion into Uruguay and Paraguay. On February 8, 2010, Cord Blood America announced that BioCells finalized an agreement to process and store cord blood specimens with Cord Blood America in Las Vegas.

Elan Corporation, plc (NYSE: ELN) reported today that the company has decided to explore the possibility of a separation of its Elan Drug Technologies (EDT) business. If executed, any transaction would create two distinct publicly listed companies: Elan BioNeurology and EDT, with each entity being a leader in its field of expertise. The purpose of this exploration is to accurately assess the opportunity and impact on shareholder value.

On an operating basis, both EDT and BioNeurology are now profitable. Each represents vastly different investment propositions, and each generates distinct and on-going capital requirements for utilization against a broad array of potential opportunities.

The company’s review will include detailed assessment of the possible separation, including timing, market conditions and the impact on all of its key constituencies. The Company expects to make a decision whether to proceed in the coming months. No specific timetable has been set for completion of the review and there can be no assurances that such a transaction will take place.

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that the commercial launch of Ceplene® (histamine dihydrochloride) will take place in the United Kingdom on April 20, 2010 in conjunction with the British Society for Haematology 50th Annual Scientific Meeting in Edinburgh, Scotland. Ceplene is approved in the European Union for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first remission.

Generex Biotechnology Corporation (Nasdaq:GNBT), today announced that it has established an action plan for obtaining cost reimbursement coverage for Generex Oal-lyn(TM), including the development of an insurance product that covers the costs of Generex Oral-lyn(TM) and any additional and/or comparable diabetes products. Some of the objectives in the action plan will include: the creation of a prospectus for use with Insurance Underwriters; the development of cost and risk assessment profile; identifying potential underwriters; and the creation of supporting actuarial and marketing materials.

Hospira, Inc. (NYSE:HSP) and Javelin Pharmaceuticals, Inc. (NYSE - Amex: JAV), today announced that the companies have entered into a definitive merger agreement providing for the acquisition of Javelin by Hospira for $2.20 per share in cash, or approximately $145 million. Hospira expects to commence a tender offer for all outstanding shares of Javelin common stock on or about April 21, 2010, in accordance with the terms of the merger agreement.

The acquisition of Javelin would allow Hospira to take advantage of synergies between Javelin's main product candidate, Dyloject™, a post-operative pain management drug currently awaiting U.S. Food and Drug Administration (FDA) approval, and Hospira's proprietary sedation agent, Precedex™. Both drugs are marketed to anesthesiologists, enabling Hospira to leverage its Precedex sales force to promote Dyloject.

"Dyloject would broaden Hospira's pain management portfolio and offers attractive revenue and margin prospects," said Ron Squarer, chief commercial officer, Hospira. "Dyloject is also a very good fit with Precedex, and further demonstrates Hospira's strong commitment to the acute-care space."

As result of the aquisition of Javelin by Hospira, Myriad Pharmaceuticals, Inc. (Nasdaq:MYRX) today announced the termination, effective as of Friday, April 16, 2010, of its merger agreement with Javelin . In accordance with the terms of the merger agreement, Myriad Pharmaceuticals is entitled to the payment from Javelin of stipulated expenses of $1.5 million plus a termination fee of $2.9 million, within one business day of the termination, and in accordance with the terms of the $8.5 million Loan and Security Agreement, is entitled to the repayment, in full, from Javelin, of the outstanding balance under the agreement, together with accrued interest thereon, within two business days of the termination.

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that Novartis has withdrawn a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval to market JOULFERON® (albinterferon alfa-2b, known in the United States as ZALBIN™) for the treatment of chronic hepatitis C.

The decision to withdraw the application was based on feedback from European regulatory authorities in preliminary response to the EMA application, indicating that additional new data would be requested which could not reasonably be generated within the timeframe allowed in the European Centralized Procedure. Feedback included whether the therapeutic benefit offered by JOULFERON dosed once every two weeks is sufficient relative to risk.

ZALBIN (JOULFERON) is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006. In November 2009, HGS submitted a Biologics License Application (BLA) to the FDA in the United States for ZALBIN dosed every two weeks, which continues under review. HGS and Novartis are also developing ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this ZALBIN regimen.

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[calopre]

Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported the development of a novel protein complex, designated as E1-L-thP1, for targeted delivery of small interfering ribonucleic acids (siRNAs) to diverse solid cancers. E1-L-thP1 was found to internalize in cells that express the TROP-2 antigen, suggesting the binding ability of hRS7 remains intact in the fusion protein. More importantly, it effectively delivered siRNAs into TROP-2-expressing cancer cells, causing cell death. Further evaluation of the in vitro and in vivo efficacy of E1-L-thP1 for delivery of CD74- and CEACAM6-specific siRNAs to treat TROP-2-expressing pancreatic cancer is ongoing. In a separate release Immunomedics reported today at the 101st Annual Meeting of the American Association for Cancer Research (AACR) results from two studies aimed at improving the design of antibody-SN-38 conjugates for targeted cancer chemotherapy.

Lannett Company, Inc. (NYSE AMEX: LCI) tracked higher today after the company announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials. Ondansetron Injection USP, 2 mg/mL is the generic equivalent of GlaxoSmithKline’s Zofran® Injection, 2 mg/mL. For the 12 months ending December 2009 U.S. sales of Ondansetron Injection USP, 2 mg/mL were approximately $58 million at Average Wholesale Price (AWP). A launch date for the product has not yet been set.

"Ondansetron Injection is the first injectable product for which Lannett has filed an ANDA and, importantly, the first product candidate approved for marketing from our joint venture with Wintac Ltd.," said Arthur Bedrosian, president and chief executive officer of Lannett. "The addition of an injectable drug to our product offering will enhance our ability to build our hospital-based business." Shares were up on 3.5% on the news.

MDRNA, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, today announced that the Intellectual Property Office of New Zealand (IPONZ) has issued a Notice of Acceptance for patent application 553828, titled "Methods of Treating an Inflammatory Disease by Double-Stranded Ribonucleic Acid." Allowed claims cover small interfering RNAs (siRNA) directed against the tumor necrosis factor (TNF) gene as well as several of the Company's key nucleic acid condensing and delivery peptide motifs in combination with a siRNA directed against TNF. This patent application was filed in 2005 as part of MDRNA's global intellectual property strategy which comprises a broad comprehensive patent portfolio protecting the Company's proprietary siRNA constructs, nucleic acid chemistry, nucleic acid delivery platforms, and its extensive library of siRNAs directed against therapeutic targets.

Micromet, Inc. (Nasdaq:MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced that results from studies highlighting pre-clinical advances with its proprietary BiTE antibody technology were presented at the American Association for Cancer Research (AACR) Annual Meeting in Washington, DC.

The Company and its collaborators reported pre-clinical data characterizing new BiTE antibodies targeting 11 tumor-associated antigens, including CEA, EGFR, IGFR-1, cMet and FAP-alpha. The data demonstrate that BiTE antibodies can be generated to target a wide range of tumor antigens of highly different function, size and molecular composition, illustrating the wide applicability of the BiTE antibody technology for the treatment of diverse cancer indications.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex mixture drugs, today announced presentation of results from a preclinical study of its novel oncology drug candidate, M402, in a murine pancreatic cancer model. The data showed thatM402, in combination with gemcitabine, significantly prolonged survival and reduced metastasis as compared to groups treated with saline alone or gemcitabine alone.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Matrix Laboratories Limited has received final 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 Didanosine Delayed-release Capsules, 125 mg, 200 mg, 250 mg and 400 mg, the generic version of Bristol Myers Squibb's HIV treatment Videx® EC. This product, which the company expects to begin marketing in the U.S. during the current quarter, will be sold under the Mylan Pharmaceuticals brand. The product will also be sold outside the U.S. in a number of developing countries.

Didanosine Delayed-release Capsules had U.S. sales of approximately $29 million for the 12 months ending Dec. 31, 2009, according to IMS Health.

Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and viral infections, today reported data from a new preclinical study demonstrating that the company's phosphatidylserine (PS)-targeting antibodies reversed immune suppression by tumors and conferred tumor-specific immunity in models of breast cancer. Said Dr. Philip Thorpe, professor of pharmacology at the University of Texas Southwestern Medical Center, a scientific advisor to Peregrine and co-author of this study. "This study shows that the immunosuppressive effects of PS exposed on apoptotic tumor cells can be reversed by PS-targeting antibodies, specifically by reversing the suppression of dendritic cell (DC) maturation caused by the exposed PS. This finding is important since reactivation of the immune system after the primary tumor has been removed is a critical line of defense in fighting cancer recurrence. Additionally, we showed that PS-targeting antibodies have the ability to confer tumor-specific immunity, which could lead to the future development of new cancer vaccine regimens."

Sequenom, Inc. (Nasdaq:SQNM) moved higher today after the company announced the launch of its next-generation mass spectrometry system – the MassARRAY® Analyzer 4. This new high performance nucleic acid analysis platform has been designed to meet customer demand for a bench top instrument with greater flexibility across multiple applications, improved reliability and faster performance. With the capability for quantitative gene expression analysis, epigenetic nucleic acid methylation analysis as well as high-throughput genotyping and SNP fine mapping applications, the MassARRAY Analyzer 4 is designed to empower the basic and translational research community to advance findings from basic genetic and biomarker studies toward clinical utility in diagnosis, prognosis and monitoring of diseases. The MassARRAY Analyzer 4 system will initially be offered to research-use-only (RUO) laboratories, and subject to FDA clearance will be released to CLIA-certified laboratories for the generation and implementation of laboratory-developed tests. Shares of Sequenom were up 4.31% or 25 cents to $6.05.

Sigma® Life Science, the innovative biological products and services brand of Sigma-Aldrich® (Nasdaq:SIAL), today introduced the world's first p53 'knockout' rat model, an important development that is expected to, due to the rat's closer physiological and metabolic similarity to humans, significantly improve timelines for carcinogenicity screening and reduce time to market for therapeutics. "Over the past twelve months, SAGE Labs has been developing novel rat models, in which specific genes associated with defined disease conditions are deactivated or knocked-out, for use in disease research, especially in areas where the existing mouse models poorly mimic human disease," said Dr. Edward Weinstein, director of SAGE Labs.

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 preclinical results presented at the American Association for Cancer Research (AACR) 101st Annual Meeting show that STA-9090, a potent, synthetic inhibitor of heat shock protein 90 (Hsp90), demonstrates synergy with standard of care therapies such as Avastin in non-small cell lung cancer models; penetrates efficiently into hypoxic (low oxygen) regions of tumors; and inhibits both HIF-1a and JAK/STAT signaling, pathways that are critical to the survival and proliferation of certain cancer types.

"STA-9090 has demonstrated encouraging signs of single-agent activity in our Phase 1 and Phase 2 clinical trials, as well as a manageable safety profile," said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. "Results presented today further support the potential for STA-9090 in treating a range of cancers, both as a single-agent and in combination with other anti-cancer agents."

YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), movd higher today after the company announced the pre-publication of pivotal preclinical data for CYT387, the company's highly selective and potent JAK1/2 inhibitor, currently in a Phase I/II trial for myelofibrosis. The paper describes work conducted in the laboratory of Dr. Michael Deininger at Oregon Health Sciences University Knight Cancer Institute, Portland, Oregon, which demonstrates that orally-administered CYT387 normalizes the hallmark MPN features of elevated blood cell counts and enlarged spleen size in an in vivo model of the disease. Importantly, blood cell production is shown to return to the bone marrow with drug treatment.

Also Monday:

Alkermes, Inc. (NASDAQ: ALKS) today announced that it will webcast its Research and Development (R&D) Day being held on Monday, April 26, 2010, at the Nasdaq MarketSite.

CDEX Inc. (OTCBB: CEXI) announces that its Board of Directors has appointed Donald W. Strickland as its new CEO.Mr. Strickland, a Director of the Company, has served in senior management positions for over 30 years and has successfully developed businesses for both large public companies and technology startups.

Celgene Corporation (NASDAQ: CELG) senior management will host a conference call and live audio webcast on Thursday, April 29, 2010 at 9 a.m. ET to discuss the company's first quarter 2010 financial and operational results.

Compugen Ltd. (NASDAQ: CGEN) today announced that the Company will host a live webcast and conference call at 10:00 AM EDT on Tuesday, April 27, 2010 to review first quarter 2010 results and to present an updated slide presentation of the company's current status and outlook.

Eli Lilly and Company (NYSE:LLY) today announced financial results for the first quarter of 2010.

Humana Inc. (NYSE: HUM) announced today that it will extend health insurance coverage for young adults currently covered by their parents’ Humana health plans during what otherwise could have been a gap in their coverage.

Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced today that it plans to report first quarter 2010 financial results on Monday, May 3, 2010. Inspire's President and CEO, Adrian Adams, and Executive Vice President and CFO, Thomas R. Staab, II, will host a conference call and live webcast on Monday, May 3, 2010 at 10:00 a.m. ET.

Millipore Corporation (NYSE: MIL), a leading provider of technologies, tools and services for the global life science industry, today announced it has begun full commercial shipments of its Scepter Handheld Automated Cell Counter to customers worldwide.

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos is presenting three scientific posters, based on collaborations with Drs. Kenneth Tew and Danyelle Townsend of the Medical University of South Carolina, Charleston, SC, and Drs. C. Marcela Diaz-Montero and Alberto Montero of the Sylvester Comprehensive Cancer Center, University of Miami, Miami FL, at the ongoing American Association for Cancer Research (AACR) 2010 Annual Meeting being held in Washington, DC.

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the U.S. Food and Drug Administration (FDA) approved the daily pill Tarceva® (erlotinib) as a maintanance treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex: RGN), a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration in cardiovascular diseases, central nervous system injuries, ophthalmic indications and dermal wounds, announced today that it intends to offer units consisting of shares of its common stock and warrants to purchase shares of its common stock in a public offering.

RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that Anastasia Khvorova, Ph.D., Chief Scientific Officer, is presenting at the 101st annual American Association for Cancer Research (AACR) Conference on April 19, 2010. The presentation will not be webcast.

Sinobiopharma, Inc. (OTC Bulletin Board: SNBP) a fully integrated and highly innovative specialty pharmaceutical company engaged in the research and development, and the manufacture and marketing of biopharmaceutical products in China, has announced its financial results for the third quarter ended February 28, 2010.

Vermillion, Inc. (Pink Sheets: VRML) today announced the appointment of Sandra A. Gardiner as Vice President and Chief Financial Officer (CFO). In her role as CFO, Ms. Gardiner will be responsible for leading all aspects of financial management for Vermillion.

Viral Genetics, Inc., (Pink Sheets:VRAL), is relocating its research facilities to the life science cluster in Georgetown, Texas.

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]

FDA panel raises concern over Acura NDA. CytRx receives positive opinion from EU committee PDF | Print | E-mail
Written by BioMedReports.com Staff
Tuesday, 20 April 2010 15:12
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Below is a list of the companies that made news in the healthcare sector on Tuesday, April 20, 2010.
Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the April 22, 2010 joint meeting of the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees meeting to discuss the New Drug Application for Acurox(R) (oxycodone HCl and niacin) Tablets and the results of studies evaluating the addition of niacin for the purpose of reducing the misuse of oxycodone.

The FDA panel stated, "Although the Acurox formulation includes a nasal irritant to deter abuse by nasal inhalation, this may not prevent an initial attempt of abuse since the formulation does not prevent from crushing the tablets and the drug abuser may not have any knowledge of the irritancy prior to snorting the crushed Acurox. Additionally, we question if the deterrent properties of this irritant could be abated through pre-treating with other substances/drugs which have nasal numbing properties, prior to the snorting of crushed Acurox. We recommend consideration be given during review of the application as to whether these known methods of abuse will be effectively impacted by the abuse deterrents in the Acurox formulation."

Shares of Acura dropped more than 21%, shedding $1.67 to end the day at $6.23.

CytRx Corporation (NASDAQ: CYTR), moved higher today after the biopharmaceutical company specializing in oncology, today announced that bafetinib (formerly known as INNO-406) has received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product for the treatment of chronic myeloid leukemia (CML). The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the community register. Bafetinib also has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the U.S. Food and Drug Administration (FDA).

CytRx recently announced plans to begin three Phase 2 proof-of-concept open-label clinical trials with bafetinib. The clinical trial in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL) is expected to commence in the first half of 2010, and clinical trials in patients with advanced prostate cancer and glioblastoma multiforme (a common and aggressive type of primary brain tumor) are expected to commence in the second half of 2010.

Shares of CytRx surged more than 11% or 12 cents, closing the day at $1.15. Volume was heavy as more than 6 Million shares traded hands.

In other news Tuesday:

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, announced study results today that demonstrate a regimen of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) given in combination with bevacizumab (Avastin®) may have potential in the treatment of triple-negative breast cancers. In the pre-clinical study, fifty percent of mice in the combination therapy group (n=10) had complete regressions of primary tumors and metastases at regional and distant sites. Nab-paclitaxel plus bevacizumab was shown to inhibit tumor growth by 100%, and reduced the incidence of lymph node and lung metastases by 50% and 87%, respectively. The findings were discussed at the 101st Annual Meeting of the American Association for Cancer Research (AACR).

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced plans to initiate a Phase 1 single-dose clinical trial of the Company’s compound, Glial Growth Factor 2 (GGF2), in patients with heart failure in mid-2010, based on an IND filed with the U.S. Food and Drug Administration (FDA) on March 19, 2010. GGF2 has been shown to protect heart muscle and restore cardiac function in preclinical models of heart failure, myocardial infarction and cardiotoxicity.
"This IND is the result of a number of years of research, planning and collaboration. Acorda’s clinical, preclinical and regulatory teams have done an outstanding job designing a development program to explore the potential of GGF2 in heart failure," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "GGF2 may represent a new approach to treating heart failure, and may also have potential applications in neurology, which we hope to investigate in subsequent clinical studies."

Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), today presented a poster on dual Erk/PI3K inhibitors and made an oral presentation on its selective Erk inhibitors, at the American Association for Cancer Research (AACR) Annual Meeting in Washington, D.C.

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that it has completed enrolling patients in all four previously announced prospective, open-label clinical studies investigating Soliris® (eculizumab) as a potential treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS) being conducted in North America and multiple European countries. The four studies have achieved the Company’s enrollment targets, with a total of approximately 35 adult and adolescent patients with aHUS.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), presented new pre-clinical data from its ALN-TTR program at the XII International Symposium on Amyloidosis in Rome on April 18 - 21, 2010. ALN-TTR01 is a systemically delivered RNAi therapeutic being developed for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR), including familial amyloidotic polyneuropathy (FAP) and familial amyloidotic cardiomyopathy (FAC). These new pre-clinical data demonstrate – for the first time – that treatment with an RNAi therapeutic can result in regression of pre-existing pathogenic TTR deposits in peripheral tissues. Additional pre-clinical data presented at the meeting demonstrated the potential application of TTR-specific siRNA for the treatment of ocular disease in ATTR.

American Medical Alert Corp. (NASDAQ: AMAC) a provider of healthcare communication services and advanced telehealth monitoring technologies, today announced that its Telephony Based Communication Services received a large award to provide clinical contact management services and brand support for an internationally recognized pharmaceutical manufacturer. AMAC’s PhoneScreen is a leader in the field of patient recruitment, retention and contact center services. The award is expected to generate approximately one million dollars in revenue over the term of the contract and is expected to commence service on or around July 2010 and run into 2011.

AngioDynamics (NASDAQ:ANGO) today announced the first patient treatment and growing enrollment in a pilot study of the use of the Company’s NanoKnife Irreversible Electroporation (IRE) System in the treatment of early stage hepatocellular carcinoma (HCC), or primary liver cancer. This clinical trial is being conducted under the supervision of Professor Jordi Bruix of the Barcelona Clinic Liver Cancer Group of the University of Barcelona and Professor Riccardo Lencioni of the University of Pisa School of Medicine.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced results of preclinical studies on its investigational anaplastic lymphoma kinase (ALK) inhibitor – AP26113 – showing potent inhibition of the target protein and of mutant forms that are resistant to the first-generation ALK inhibitor, which currently is in clinical trials in patients with cancer. ARIAD scientists presented these data today at the annual meeting of the American Association for Cancer Research (AACR) in Washington, D.C.
Genetic studies indicate that abnormal expression of ALK is a key driver of certain types of non-small cell lung cancer (NSCLC) and neuroblastomas, as well as anaplastic large cell lymphoma. Since ALK is generally not expressed in normal adult tissues, it represents a highly promising molecular target for cancer therapy.

Arrayit Corporation (OTCBB:ARYC), a leader in life sciences and healthcare technology, announced today that members of Arrayit management will present at the Southern California Investment Association (SCIA) Summer Capital Conference in Irvine, California on Saturday, June 5, 2010.

ATS Medical, Inc. (Nasdaq:ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced the first commercial implant of the ATS 3f® Aortic Bioprosthesis was recently completed by Liu Zhi Gang, MD at Fu Wai Hospital in Beijing, China. Fu Wai Hospital is the largest cardiac surgery center in Asia and a full line of ATS products are utilized by their surgeons. ATS received permission from the Chinese State Food and Drug Administration (SFDA) to market the ATS 3f Aortic Bioprosthesis in March. "The ATS 3f Aortic Bioprosthesis is much easier to implant than other stentless valves. This is especially important in the small sizes," stated Dr. Liu. A size 23 mm 3f Aortic Bioprosthesis was implanted with a resulting mean pressure gradient of 5 mmHg, which is considered an excellent hemodynamic performance for the smaller size aortic annulus.

Bovie Medical Corporation (AMEX: BVX), edged higher today after the manufacturer and marketer of electrosurgical products, announced it has been awarded a contract by the General Services Administration (GSA). Bovie’s Federal Supply Schedule (FSS) was awarded by the Office of Acquisition and Materiel Management's National Acquisition Center (NAC), located in Hines, Illinois. The NAC is the largest combined contracting entity within the Department of Veterans Affairs (VA) and is responsible for supporting the health care requirements of the VA as well as the needs of other Government agencies. The initial contract period is for five years..

BioDelivery Sciences International, Inc. (Nasdaq:BDSI), a specialty pharmaceutical company, announced that it has entered into a definitive securities purchase agreement with a group of select institutional investors to purchase US$10 million of its securities in a registered direct offering. No placement agent was utilized in connection with the offering.Under the terms of the securities purchase agreement, BDSI will sell an aggregate of 2,824,858 shares of its common stock at a price of US$3.54 per share and issue warrants to acquire an aggregate of 1,412,429 shares of common stock, which warrants will have an exercise price of $4.67 per share.

Bio-Matrix Scientific Group Inc. (OTC.BB:BMSN) today announced the elimination of an additional $1,109,309 in obligations during the quarter ended March 31, 2010. These obligations, including $251, 528 owed on loans made to BMSN by a company controlled by Chairman & CEO Dr. David Koos as well as $304,500 in accrued salaries, were satisfied through the issuance of 17,337,728 shares of common stock. Dr. Koos stated, "I believe the future of Bio-Matrix Scientific Group Inc. is bright. Our majority owned subsidiary, Entest BioMedical, Inc. is making what I believe to be great strides in developing revolutionary new therapies

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Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announced that it has established a $25 million credit facility with Silicon Valley Bank and up to $4 million in convertible debt with Partners for Growth. Proceeds will be used to consolidate existing outstanding debt, provide working capital for growth and for general corporate purposes.

Celsion Corporation (Nasdaq:CLSN) today announced that Dr. Thanjavur S. Ravikumar, from the Geisinger Health System and a principal investigator of the Phase I ThermoDox® dose escalation trial, gave an oral presentation at the Liver Tumors Panel session of the 9th World Congress of the International Hepato-Pancreato-Biliary Association (IHPBA) in Buenos Aires, Argentina. The presentation, titled "A Phase I Trial of ThermoDox® in Patients Undergoing Radiofrequency Ablation (RFA) of Liver Tumors," provided a summary of the data as well as illustrative patient case studies. The trial results not only support the use of ThermoDox® plus RFA for the treatment of primary liver cancer, but also provide supportive evidence for Celsion to evaluate the effects of ThermoDox in patients with colorectal liver metastases (CRLM).

Cord Blood America, Inc. (OTC Bulletin Board:CBAI.ob),announced that it has signed a Definitive Supplier Agreement with a well respected, accredited, tissue bank providing placenta collection services for therapeutic transplantation, and Cord Blood America is already filling orders.

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 disorders, today announced the presentation of preclinical results for several of its pipeline compounds during the American Association of Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, DC.

DARA BioSciences, Inc. (NasdaqARA) announced today that the company has been selected by the Scientific Programme Committee to present results from its Phase 2 study at the Congress on May 29, 2010 in Athens, Greece..

Dyax Corp. (NASDAQ: DYAX) announced today that it has sold its rights to royalties and other payments related to the commercialization of Xyntha by Pfizer, Inc., a licensee under the Company’s phage display Licensing and Funded Research Program (LFRP), to an investment fund managed by Paul Capital Healthcare. Under the terms of this sale, Dyax received an upfront cash payment of $10 million and will be eligible to receive milestone payments totaling up to $2 million based on Xyntha sales in 2010 and 2011.

Genta Incorporated (OTCBB: GETA) moved higher today after the company announced the presentation of initial results from the first human use of a gallium-containing compound to treat serious infection. In a patient with cystic fibrosis and a highly resistant lung infection, who has been treated over a 2-year period, high concentrations of gallium were achieved in sputum. Moreover, sputum concentrations were higher than simultaneous concentrations in blood and continued to rise even after treatment had been stopped. Measured concentrations in sputum equaled or exceeded concentrations that have been reported lethal to bacteria in laboratory tests. "These data show that gallium is preferentially concentrated in sputum of infected lungs," said Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive Officer. "High levels were achieved and sustained during short courses of treatment -- an especially promising result that should obviate any need to consider direct inhalation. A new clinical trial to formally evaluate IV gallium nitrate in patients with cystic fibrosis will begin next month. These preliminary data also suggest that our oral gallium-containing compound may be useful for this purpose as chronic therapy."

Gilead Sciences, Inc. (Nasdaq:GILD) provided an update today on the development of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg). As part of its First Quarter 2010 earnings call, Johnson & Johnson, which owns Tibotec Pharmaceuticals, announced today that the two pivotal Phase III studies evaluating TMC278 as a treatment for HIV in treatment-naïve patients met the primary efficacy objective of non-inferiority as compared to efavirenz based on the proportion of patients achieving HIV RNA levels of less than 50 copies/mL at 48 weeks. Johnson & Johnson also announced that full study results will be presented at a scientific meeting later this year, and that the submission of TMC278 for regulatory review is on track for the third quarter of this year. In a seperate release the company announced that is stopping its ongoing Phase II clinical trial of GS 9450, an investigational caspase inhibitor, in patients with chronic hepatitis C.

Haemonetics Corporation (NYSE:HAE) announced today that Neoteric Technology Ltd, a corporate acquisition in 2009, currently doing business as Haemonetics Canada, LTD, was named the LifeSciences British Columbia Medical Device Company of the Year. In particular, the award recognized the revolutionary BloodTrack® blood transfusion and inventory management system. The BloodTrack suite is comprised of eight solutions, including the HemoSafe automated blood dispensing system and BloodTrack Tx, a bedside point-of-care system that utilizes the latest mobile bar code technology to ensure that the right blood is transfused to the right patient. Each BloodTrack solution is integrated into BloodTrack Manager, a central dashboard that provides hospitals with a comprehensive, real-time view of their entire transfusion service.

Human Genome Sciences, Inc. (Nasdaq: HGSI) fell today after the company, along with GlaxoSmithKline PLC (NYSE:GSK) announced topline secondary endpoints from BLISS-76, the second of two pivotal Phase 3 trials of BENLYSTA™ (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The results showed that at Week 76 in the BLISS-76 study, belimumab plus standard of care showed higher response rates compared with placebo plus standard of care as measured by the SLE Responder Index; however, this secondary endpoint did not reach statistical significance. Study results, however, showed that belimumab continued to be generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups. Shares fell more than $2.00 on the news.

Hypertension Diagnostics, Inc. (OTC.BB:HDII) jumped higher today as the company reported that new medical research data published in the American Journal of Epidemiology provides significant evidence that Hypertension Diagnostics, Inc.'s (HDI) non-invasive CardioVascular Profiling test, which measures the elasticity of the small blood vessels, is the earliest and best predictor of hypertension when compared to several more established and expensive testing methodologies used by physicians and cardiologists..

Immunomedics, Inc. (Nasdaq:IMMU), today reported that a new blood test using the Company's proprietary humanized antibody, clivatuzumab or PAM4, predicted a partial response in an initial set of patients treated with a combination of the antibody labeled with yttrium-90 (Y-90) and gemcitabine. "We have now demonstrated that the blood assay for PAM4-protein can not only detect early-stage pancreatic cancer, as has recently been reported by us, but may also predict a lack of response to therapy or an early relapse," remarked Cynthia L. Sullivan, President and CEO. "As a result, we believe we may be one step closer to offering an individualized approach for the management of this lethal disease," Ms. Sullivan added.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that it earned a $6.5 million payment from Roche (SWX: ROG.VX; RO.S, OTCQX: RHHBY) as a result of Roche progressing RG7348 into a Phase I clinical trial for the treatment of hepatitis C viral (HCV) infection. The milestone payment arises from a 2008 collaboration and license agreement between Roche and Metabasis Therapeutics, Inc. Ligand acquired Metabasis in January 2010. Ligand’s net proceeds from the milestone payment will be approximately $2.3 million after paying $4.2 million to others including holders of the Ligand-issued "Roche" CVR.

Mannatech, Incorporated (NASDAQ: MTEX), a global pioneer in the development of high-quality health, weight and fitness, and skin care solutions based on nutritional science, announced the results of an independent study that demonstrated its proprietary Ambrotose-complex and Advanced Ambrotose-powder exerted prebiotic effects. Its findings determined both Ambrotose complex and Advanced Ambrotose powder exhibited good selective fermentability throughout the entire colon, positive and selective bifidogenic effects and also demonstrated the possibility of enhancing species belonging to Bacteroidetes.

Marshall Edwards, Inc. (NASDAQ:MSHL), a specialist oncology company focusing on the clinical development of novel anti-cancer therapeutics, today announced that the Company has received notice from the Nasdaq Listing Qualifications Panel that it has regained compliance with the $1.00 minimum closing bid price requirement in accordance with the Nasdaq Listing Rules for continued listing on the Nasdaq Global Market.

Myriad Pharmaceuticals, Inc. (Nasdaq:MYRX) today announced the presentation of preclinical data characterizing MPI-0486348, the lead compound in the company's Nicotinamide phosphoribosyltransferase (Nampt) inhibitor pre-clinical program at the American Association for Cancer Research (AACR) 101st Annual Meeting in Washington, D.C.

NeoPharm, Inc. (OTC: NEOL.PK), moved higher today after the company announced that it has started enrolling patients in its Phase II clinical trial for liposome entrapped docetaxel (LE-DT), as a frontline treatment of pancreatic cancer patients with locally advanced or metastatic disease. LE-DT is a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere.
"Unfortunately, pancreatic cancer is one of the cancers which has no effective treatment. We are hoping that this new modality of treatment with LE-DT will bring some hope and treatment options to those unfortunate patients" commented Dr. Aquilur Rahman, President and Chief Executive Officer of NeoPharm.
"Following the very impressive results of the LE-DT Phase I trial, this open-label, Phase II study will help us determine the antitumor effect of LE-DT in this lethal disease. Progression Free Survival and Overall Survival along with a number of biologic markers such as CA-19-9 and SPARC expression, which are potentially related to the response of the disease, will be monitored. In addition, we will be evaluating the quality of life in these patients with metastatic disease."

Neuralstem, Inc. (NYSE Amex: CUR) shot higher on heavy volume and no apparent news. The stock was up 18.42% or 42 cents to $2.70. Volume of over 3 million shares was more than twenty times the daily average.

Ohr Pharmaceutical Inc. (OTC.BB:OHRP) announced today that it has established its headquarters in New York City. The Company was previously based in Salt Lake City on an interim basis.

Prana Biotechnology (NASDAQ:PRAN) (ASX:PBT) today announced that it is finalising plans to commence a definitive Phase IIb trial of its lead Alzheimer's disease drug, PBT2, before the end of this year.
The Phase IIb trial will involve 525 patients with mild to moderate Alzheimer's disease. Treatment will be over a period of 12 months, with the key performance measure being cognition (including ADAS Cog* and Executive Function tests from the NTB*). The trial, a double blind placebo controlled study, will test the efficacy of 2 doses of PBT2 (250mg and 100mg). "We are excited by this protocol because we already know how patients benefited from a 250mg dose of PBT2 in just 12 weeks, so we are confident the benefit will be even stronger and more pronounced over a 12 month trial," said Mr. Kempler. "This trial is all about cognition and helping patients."

QLT Inc. (Nasdaq:QLTI) (TSX:QLT) jumped up more than 5% after the company today announced interim results from the first 3 subjects enrolled in a Phase 1b clinical proof-of-concept study of QLT091001 in the treatment of Leber congenital amaurosis (LCA), an inherited progressive retinal degenerative disease that leads to retinal dysfunction and significant visual impairment beginning at birth. QLT091001 is an orally administered synthetic retinoid replacement for 11-cis-retinal, which is a key biochemical component of visual function.

Seattle Genetics, Inc. (Nasdaq: SGEN) moved higher today after announcing that Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), will pay $9.5 million to renew exclusive licenses to specific targets and extend the research term under the parties’ existing antibody-drug conjugate (ADC) collaboration agreement. Under the terms of the agreement, Genentech has rights to use Seattle Genetics’ ADC technology with antibodies against targets selected by Genentech. Genentech is responsible for research, product development, manufacturing and commercialization. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on net sales of any resulting ADC products. Seattle Genetics has generated approximately $120 million through ADC technology license agreements with leading biotechnology and pharmaceutical companies. ADCs utilize the targeting ability of monoclonal antibodies to deliver potent, cell-killing payloads to specific cells.

STERIS Corporation (NYSE:STE) today announced it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the terms of a consent decree regarding its SYSTEM 1® liquid chemical sterilization system. Included in the agreement is a Transition Plan with a Rebate Program for current SYSTEM 1 Customers in the U.S. The consent decree is subject to approval by the U.S. District Court for the Northern District of Ohio.
In general, the agreement resolves the government’s complaint relating to the FDA’s allegations in its May 2008 warning letter, prohibits the sale of liquid chemical sterilization or disinfection products that do not have FDA clearance, formalizes STERIS’s Rebate Program and the continued support of SYSTEM 1 Customers during the FDA authorized transition time period, and describes various process and compliance issues.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA), edged higher today after the company announced preclinical results presented at the American Association for Cancer Research (AACR) 101st Annual Meeting that support correlative markers for elesclomol anti-cancer activity. In addition, results were presented by Synta collaborators showing that elesclomol demonstrates activity in cisplatin-resistant lung cancer models.
"The results presented today are encouraging and support the continued clinical development of elesclomol," said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta. "Our improved understanding of the activity of elesclomol will allow us to concentrate our clinical efforts on those patients who are most likely to benefit from treatment."

Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), today announced multiple preclinical presentations on its clinical stage hypoxia-activated prodrug, TH-302, at the American Association for Cancer Research (AACR) Annual Meeting." These are very exciting preclinical results which extend our understanding of the mechanism of action and antitumor activity of TH-302," said Charles Hart, Ph.D., Threshold's vice president of biology. "Our translational observations provide further support that TH-302 is selectively targeting tumor hypoxia and continue to inform the design of our clinical programs."

Viking Systems (OTCBB:VKNG) moved up today as the company announced that preclinical surgical video created using a Viking Systems' "Next Generation" 3DHD prototype visualization system displayed on a Sony prototype medical grade 3DHD monitor was enthusiastically received during The 12th World Congress of Endoscopic Surgery.

Vicor Technologies, Inc. (OTC.BB:VCRT), today announced the results of a pilot study to test the ability of its PD2i nonlinear algorithm to detect acute hypovolemia. "We are very encouraged by the results achieved by the PD2i in this small pilot study, which suggest the prospect of incorporating the PD2i nonlinear algorithm into a noninvasive diagnostic for use in identifying patients who are bleeding internally stated David H. Fater, CEO. The company is currently in the process of commercializing diagnostics that accurately risk stratify specific target populations for future pathological events including sudden cardiac death and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.

Wellstar International Inc. (OTCBB: WLSI) has announced they will be installing a TMI Imaging system in a Doctor’s office in Torrance, California. The system will be used primarily for the detection of inflammation and neuropathy. The practice specializes in treating patients with diabetes. Neuropathy, inflammation and lack of circulation are very prevalent with Diabetes. The TMI System will be able to detect and track the inflammation, neuropathy and possible deep tissue damage caused by lack of circulation.

Winner Medical Group Inc. (Nasdaq:WWIN), a leading manufacturer of medical dressings, medical disposables and non-woven PurCotton(R) materials for the medical and consumer products industries, announced today that since January 1, 2010, it has opened nine PurCotton(R) chain stores, and an additional eight new stores will be opened by the end of April in Shenzhen, Guangdong province, China.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), tracked higher as the company announced today that preclinical data on the novel organic arsenic darinaparsin (Zinapar, or ZIO-101) were presented at the American Association for Cancer Research (AACR) Annual Meeting .

Also Tuesday:

Abbott (NYSE:ABT) today announced the successful completion of the tender offer by its wholly owned subsidiary Amber Acquisition Inc. to purchase all of the outstanding shares of common stock of Facet Biotech.

Aoxing Pharmaceutical Company Inc. (NYSE Amex:AXN) today announced that Aoxing Pharma is invited to present at Deutsche Bank Access Asia Conference 2010 in Singapore from May 10 to May 13, 2010.

Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its first quarter 2010 results.

Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, today announced it has received its first handheld integrated optical biosensor (IOBS) unit from Los Alamos National Security, LLC.

China Pharmaceuticals, Inc. (OTC Bulletin Board: CFMI) today announced financial results for its fiscal year ended December 31, 2009.

CorMedix Inc.(NYSE Amex: CRMD.U), a pharmaceutical company focused on developing and commercializing therapeutic products for the treatment of cardiorenal disease, today announced that the U.S. Patent and Trademark Office has issued a patent for the use of Neutrolin® for preventing infection and clotting in hemodialysis catheters.

CVS Caremark (NYSE:CVS) today announced results of a survey of the company's specialty pharmacy patients that provides insights into their views on medication adherence and their perceptions about the role of their specialty pharmacy.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that preclinical data in neuroblastoma for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR), currently being held in Washington, DC.

Medical Marijuana Inc (PINKSHEETS:MJNA) has begun the pre-launch of its newest division, The Hemp Network.

RAE Systems Inc. (NYSE Amex: RAE) today announced it will showcase its top-of-the-line gas-detection solutions -- including its industry-leading wireless systems -- at the Fire Department Instructors Conference (FDIC 2010) in Indianapolis, Ind. April 19-24 with a "dramatic" enactment of an hazardous-materials incident and real-time response.

Renhuang Pharmaceuticals, Inc. (Pink Sheets: RHGP), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines, today announced the appointment of Dr. Changxiong Sun and Mr. Bingchun Wu to its Board of Directors as independent directors effective April 19.Dr. Sun and Mr. Wu will join the Company's Audit Committee, which is chaired by independent director Mr. Sean Shao.

SuperGen, Inc. (NASDAQ:SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today announced that it will release its 2010 first quarter financial results on Monday, April 26, 2010.

Talecris Biotherapeutics Holdings Corp. (Nasdaq: TLCR) held its annual meeting of stockholders today in Chapel Hill, N.C.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced today that it has given notice of its intention to redeem all of the outstanding Floating Rate Convertible Senior Debentures due 2033 (the "2033 Convertible Notes").

Vermillion, Inc. (Pink Sheets: VRML) today announced that the United States Bankruptcy Court for the District of Delaware approved the final fee application in the case.

XenoPort, Inc. (Nasdaq:XNPT) announced today that it will provide access via the World Wide Web to its presentation at the 35th Annual Deutsche Bank Health Care 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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Charles River Laboratories International, Inc. (NYSE: CRL), a leading global provider of research models and associated services and of preclinical drug development services, and WuXi PharmaTech Inc. (NYSE: WX), a leading drug research and development outsourcing company with expertise in discovery chemistry and with operations in China and the United States, today announced that they have signed a definitive agreement under which Charles River and WuXi will combine in a cash and stock transaction valued at approximately $1.6 billion.

The combined company, which will retain the name Charles River, will offer an expanded portfolio of products and outsourced services to multinational pharmaceutical, biotechnology and medical device companies and academic and government institutions who increasingly seek the flexibility to access high quality, early-stage drug development expertise from chemistry to man from one global company.

Shares of WuXi jumped more than 17%, closing the day at $19.41, up $2.84. Charles River, which also announced lower 1st quarter today, slumped on the news, dropping more than 15%, closing at $33.55, off $6.62.

After the bell Monday:

NexMed, Inc. (NASDAQ: NEXM) surged after the bell today announced that the U.S. Food & Drug Administration has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.

The Company also noted that in IND review communication, the FDA has given NexMed the opportunity to move PrevOnco directly into a Phase 3 trial that would support marketing approval, subject to positive study results. In order to pursue this regulatory path, NexMed would need to expand the proposed Phase 2 study design to use PrevOnco in combination with Doxorubicin as a second-line therapy for patients who have failed NEXAVAR, the currently marketed first-line anticancer treatment for patients with either HCC or advanced renal cell carcinoma (cancer of the kidney).

PrevOnco incorporates lansoprazole, which is the generic anti-ulcer compound approved under the name Prevacid and marketed in the U.S. by Takeda Pharmaceuticals North America, Inc. In vitro and in vivo data generated to date has demonstrated the ability of lansoprazole to inhibit tumor cell growth and enhance survival in mouse models of cancer alone, and in combination with Doxorubicin.

Shares moved up 55% in the after hours market.

Dynavax Technologies Corporation (NASDAQVAX) shot up after the bell today as the company presented preclinical data that confirms the expected immunogenicity and mechanistic effects of its Universal Flu vaccine. In addition to the demonstrated ability of Dynavax's vaccine to generate cytotoxic T-cells and cytotoxic antibodies, the data presented today at the Thirteenth Annual Conference on Vaccine Research in Baltimore, MD, show that the universal components of Dynavax's vaccine enhance the efficacy of a standard flu vaccine by increasing antibody production directed at virus neutralization. These data are key indicators of immunogenicity and the potential for dose-sparing in the event of a pandemic. Dynavax's Universal Flu vaccine is uniquely designed to combine a TLR9 agonist and two conserved antigens, NP and M2e, with a standard trivalent flu vaccine.

"The vaccine candidate presented at the Vaccine Research conference represents the final formulation that we intend to take into the clinic. We have now confirmed the key biological effects of this molecule, and are on-track to begin clinical development imminently," noted Dino Dina, M.D., President and CEO.

After the bell shares jumped nearly 7% on heavy volume.

In other news Monday:

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that Novartis has elected to fully exercise its current right to purchase 55,223 unregistered shares of Alnylam’s common stock in accordance with the terms of the Investor Rights Agreement between Alnylam and Novartis, dated September 6, 2005. The exercise of this right and election to purchase the maximum number of additional shares under the terms of the Agreement allows Novartis to maintain its current ownership level of Alnylam common stock of approximately 13.4%.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has entered into an Option Agreement with an undisclosed large multi-national pharmaceutical company to obtain a non-exclusive worldwide license for the use of BioSante’s 2A/Furin technology in the expression of antibodies. The technology is covered by four issued U.S. patents incorporating BioSante’s 2A/Furin technology into antibody expression in viral vectors in order to rapidly generate stable, high producing antibody cell lines. The subsequent cell lines may greatly reduce the time and lower the cost of antibody production compared to current commercial technologies. Financial terms of the Option Agreement were not disclosed. The option period will last up to six months, at which time the multi-national pharmaceutical company may exercise its option to enter into a non-exclusive license for the use of BioSante’s 2A/Furin technology."The market for antibody products was approximately $31 billion in 2008 and growing," said Stephen M. Simes, president and chief executive officer of BioSante.

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) announced today that it has received notice from The NASDAQ Stock Market confirming that the Company has regained compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market.

Digirad Corporation (NASDAQRAD), surged higher today after the company announced that it has received 510(k) clearance from the U.S. Food and Drug Administration, enabling the Company to market and distribute Ergo, its large field-of-view, general-purpose portable imaging system. Digirad CEO Todd P. Clyde stated, "The ergo system is an important milestone in our strategy to expand our business in the hospital sector by introducing a series of advanced solid-state cameras that are distinguished by their ability to deliver higher clinical value and return on investment than conventional photomultiplier-based camera technologies generally in use today. The ergo provides institutions with the means to dramatically reduce costs for many procedures, improve patient satisfaction, raise productivity and flexibility, and the capability to generate revenues from new procedures -- all critical considerations for hospitals today." Shares closed up 33 cents to $2.39.

Dr. Reddy’s Laboratories (NYSE:RDY) announced today that it launched amlodipine benazepril capsules (2.5mg/10mg, 5mg/10mg, 5mg/20mg, 10mg/20mg), a bioequivalent generic version of Lotrel Capsules, in the US market on April 23, 2010. In September 2009, Dr. Reddy’s had entered into a patent settlement with Novartis on amlodipine benazepril stipulating the dismissal of the lawsuits in the United States. The United States Food & Drug Administration (USFDA) granted an approval of Dr. Reddy’s ANDA for amlodipine benazepril on April 15, 2010.

Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) announced today that Bruce Cozadd, the company's Chairman and Chief Executive Officer, will present at Deutsche Bank's 35th Annual Health Care Conference on Monday, May 3, 2010.

Kinetic Concepts, Inc. (NYSE: KCI) today announced the introduction of V.A.C.Via Therapy System, a next-generation negative pressure wound therapy solution that offers clinicians and patients a mobile healing technology with the proven benefits and outcomes of V.A.C. Therapy. V.A.C.Via’s design and engineering brings to the marketplace a combination of the lightest, most mobile and most intuitive technology in this space, to date. The U.S. Food and Drug Administration cleared V.A.C.Via in March. The company is planning its global launch in the third quarter.

Life Technologies Corporation (NASDAQ:LIFE) today debuted the life science industry’s first benchtop sample preparation system designed to increase productivity while eliminating manual and contamination-related challenges traditionally associated with protein and epigenetic protocols. The Invitrogen MAGic™ Sample Processor enables researchers to cut protocol time in half, dramatically reduce experimental errors, and perform technically challenging experiments in protein purification and epigenetics.

Medtronic (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) 510(K) clearance and U.S. launch of the PoleStar® N30 Surgical MRI system, the latest in neuro oncology surgical solutions.

Providing real-time imaging in the operating room (OR), the PoleStar Surgical MRI provides surgeons with targeting and navigational accuracy despite the anatomy movement that may occur during a surgical procedure. With intra-operative imaging information, neurosurgeons gain more confidence to achieve maximum tumor resection, while avoiding critical areas of the brain. Use of the PoleStar system may also reduce the need for revision surgeries and the length of stay at the hospital for the patient.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market Methamphetamine Hydrochloride Tablets USP, 5 mg, based on an agreement with licensing partner Coastal Pharmaceuticals. This product, used for the treatment of attention deficit hyperactivity disorder or obesity, is the first generic version of Lundbeck's Desoxyn to be approved by the U.S. Food and Drug Administration (FDA).

Methamphetamine Hydrochloride Tablets had U.S. sales of approximately $9.3 million for the 12 months ending Dec. 31, 2009, according to IMS Health. Mylan's version is available for immediate shipment.

Neurocrine Biosciences, Inc. (Nasdaq:NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Deutsche Bank 35th Annual Health Care Conference in Boston which takes place Monday, May 3, 2010.

OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that it has completed enrollment in the RADIANT study, a Phase III clinical trial testing Tarceva as an adjuvant therapy in patients with Stage IB-IIIA non-small cell lung cancer (NSCLC) who have undergone surgery and have EGFR-positive tumors. RADIANT is an international, randomized, double-blinded, placebo-controlled Phase III study that has reached its enrollment goal of 945 patients. The primary objective of the study is to determine whether the targeted therapy Tarceva prolongs disease-free survival when given as an adjuvant therapy. This is defined as a cancer treatment that is given after the primary treatment, which is typically surgery or surgery and chemotherapy in this group of NSCLC patients, to lower the risk of the cancer coming back.

SuperGen, Inc. (NASDAQ: SUPG) today reported financial results for the first quarter ended March 31, 2010.

"SuperGen made significant progress on all critical fronts during the first quarter of 2010, including strengthening our financial position, augmenting our team with new talent, and advancing our portfolio of discovery and development programs and our existing epigenetics partnership with GlaxoSmithKline (GSK). Eisai and Johnson & Johnson continue to expand the worldwide market for Dacogen for Injection, as demonstrated by an 11% growth in current quarter royalty revenue compared to the same prior year period," said James S.J. Manuso, Ph.D., President and Chief Executive Officer. "We were profitable in 2009 and for the 2010 first quarter, our financial position remains strong, and we have sufficient operating cash to fund our anticipated development initiatives during 2010 and beyond."

ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of innovative products for processing and storing adult stem cells, announced today that it has signed two new distribution agreements that will further extend its global reach into Asia and Central and South America for its offerings in the bone marrow stem cell regenerative medicine market. The Company has now completed four new distribution agreements in the past 90 days, significantly enhancing its ability to market and sell its products throughout the world.

Thoratec Corporation (Nasdaq:THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has signed a definitive agreement to sell its International Technidyne Corporation (ITC) division to Danaher Corporation (NYSEHR). The terms of the transaction call for an initial payment to Thoratec of $110 million in cash upon closing. In addition, the agreement includes an earn-out based on annual gross profit levels achieved by the division's Alternate Site business.

Urigen Pharmaceuticals, Inc. (OTCBB: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that the secured debt held by Platinum-Montaur Life Sciences, LLC has been converted into a newly created Series C Preferred Stock of the Company. As a result of the conversion, the lien on the Company’s assets, including its intellectual property will be extinguished.

Also Monday:

Amgen (Nasdaq: AMGN) today announced that the Board of Directors has appointed Robert A. Bradway president and chief operating officer (COO), effective May 11.

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the Company's previously announced 1-for-25 reverse stock split is now effective, and the Company's common stock will begin trading on a split adjusted basis on the NYSE Amex when the market opens today.

Covidien (NYSE: COV), a leading global provider of healthcare products, today introduced EXALGO (hydromorphone HCI) Extended-Release Tablets, (CII), the only extended-release hydromorphone treatment available in the United States.

ChromaDex Corporation (OTC Bulletin Board: CDXC), a natural products chemistry company which provides novel and innovative ingredients to the dietary supplement, food, beverage and cosmetic markets, announced today the launch of pTeroPure™ pterostilbene(tero-STILL-bean).

Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that it will conduct the second of its series of four conference calls focused on the drugs in Isis' development pipeline.

Metropolitan Health Networks, Inc. (NYSE AMEX: MDF), a leading provider of healthcare services in Florida, today announced the appointment of six new independent directors to the company's board and the re-appointment of Michael Earley, as the company's Chairman and Chief Executive Officer.

NanoViricides, Inc. (OTC BB: NNVC.OB), announced today that the mark nanoviricides has now become a registered trademark under the US Patents and Trademarks Office (USPTO). The mark was entered into the principal register of trademarks at the USPTO on April 20, 2010.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Deutsche Bank 35th Annual Health Care Conference in Boston.

PositiveID Corporation (NASDAQ: PSID), in conjunction with its development partner RECEPTORS LLC, ("Receptors") announced today that the companies have achieved a milestone in the development of their in vivo glucose-sensing RFID microchip to detect glucose levels in the body.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will report first quarter 2010 financial results following the close of the U.S. financial markets on Monday, May 10, 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.

[alfvito]

ciao raga che ne pensate di questo titolo ? pensate che possa risalire?

[fabenrico]

Originalmente inviato da bilions

appa è un'ottima opportunità di raddoppio del capitale ,io sono in accumulo tra 6-8 mesi ne riparliamo

scusate, appa che farmaco ha in sperimentazione e quali sono i tempi di un'eventuale approvazione? grazie a chi vorrà rispondermi