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  1. #1

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    Newron

    Il reclutamento richiederà ancora 3-4 mesi ...

    Come d'abitudine Weber non si smentisce.

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    Citazione Originariamente Scritto da Misterch Visualizza Messaggio
    Il reclutamento richiederà ancora 3-4 mesi ...

    Come d'abitudine Weber non si smentisce.

    Questa volta non mi sento di dare la colpa a Weber; le ragazze volontarie che provano il Sarizotan non sono di facile spostamento; richiedono sempre la presenza di un parente e di un medico o infermiere che le accompagnino; poi negli ospedali dove viene fatta la sperimentazione si può fare solo una ragazza per volta; la maggior parte di loro non cammina, quindi richiedono lettini speciali. Purtroppo questa Rett Syndorm è davvero una bruttissima bestia. Speriamo proprio che il nostro Sarizotan porti un po' di sollievo a quelle sventurate e alle loro famiglie.

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    Ci toccherà soffrire ancora parecchio prima di avere i dati del Sarizotan. Io è dal 2007 che soffro e comincio ad esserne un po' stufo.
    Anche l'Evenamide si fa parecchio aspettare. Quando entrerà in fase II ? Speriamo presto.

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    tok tok
    ora di entrare

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    Citazione Originariamente Scritto da DollarDollar Visualizza Messaggio
    tok tok
    ora di entrare
    E' da molto che lo dici, ma l'azione va sempre più giù; decisamente hai sbagliato il timing.
    Io resto alla finestra e aspetto che Zambon decida se provare lo Xadago anche per la discinesia; dovrebbe essere questione di poche settimane.
    Aspetto poi la fine del reclutamento per il Sarizotan e l'inizio della fase IIb per l'Evenamide.
    Insomma, dopo 12 anni di attesa, vivo ancora di attese.

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    il test dura sei mesi e gli ultimi iniziano ora con le loro curre, i primi hanno gia finito, senza nessun problema notevole! ora bisognia aspettare che finiscono anche questi ultimi inloro sei mesi di test...

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    28 febbraio 201809:32
    Malattie rare, 250mila italiani colpiti: 42mila nuovi casi in due anni

    In occasione della Giornata mondiale, lʼIstituto superiore di sanità presenta i dati raccolti fino al 31 dicembre 2017

    Malattie rare, 250mila italiani colpiti: 42mila nuovi casi in due anni

    Salgono a oltre 250mila le persone affette da malattie rare in Italia censiti dall'apposito Registro Nazionale, con quasi 42mila nuovi casi registrati nell'arco di due anni. Lo riferisce l'Istituto superiore di sanità in occasione della Giornata mondiale dedicata alle patologie rare, che si celebra il 28 febbraio, aggiornando le stime sulla base delle segnalazioni raccolte fino al 31 dicembre 2016.


    Il Registro Nazionale Malattie Rare, che annovera solo le malattie riconosciute dai Lea (Livelli essenziali di assistenza), conta ad oggi 250.116 casi (il precedente aggiornamento ne riportava 195.452), di cui 41.920 riferibili al biennio 2015/16.

    Le patologie più diffuse - Secondo gli esperti, l'aumento è frutto dell'ampio lavoro di ricerca e sensibilizzazione, oltre che al miglioramento delle tecniche diagnostiche. Restano però ancora tanti i malati senza diagnosi. Le patologie con maggiore frequenza sono le malattie del sangue e degli organi ematopoietici (15,3%), seguite dalle malformazioni congenite (11,3%) e dalle malattie dell'occhio (11,1%), le neuromuscolari (8,9%) e neurologiche (8,5%).

    Nasce lo sportello legale gratuito - In occasione del Rare Disease Day 2018 sarà inoltre presentato un nuovo servizio dedicato ai pazienti: lo sportello legale "Dalla parte dei Rari", nato per aiutare le persone a orientarsi nei grovigli del mondo legale, fiscale e burocratico. Il servizio, completamente gratuito, è attivo dal 28 febbraio e per accedervi è sufficiente collegarsi al sito.

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    nasdaq arriviamoooo

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    Newron announces 2017 financial results and provides outlook for 2018
    Milan, Italy, March 1, 2018 – Newron Pharmaceuticals S.p.A. (“Newron”), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announces its financial results and operational highlights for the year ended December 31, 2017, and provides an outlook for 2018. Additionally, Newron announces the approved agenda for the Company’s 2018 shareholders’ meeting.

    Highlights:

    Xadago® (safinamide)

    Xadago available in the US for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa, following US FDA approval
    Newron received EUR 11.3 million milestone payment for US approval of Xadago
    Zambon launched Xadago in Portugal, Austria and Finland for patients with mid- to late-stage Parkinson’s disease; Xadago now available in 14 European countries
    Zambon entered into partnerships and collaborations for Australian/New Zealand, Canadian and Israeli markets
    Dossiers for marketing authorization currently under review in Australia, Brazil, Canada and Colombia
    Meji Seika entered into a collaboration with Eisai for the development and commercialization in Japan and key territories in Asia; the partners announced that the primary endpoint was met in Ph II/III clinical study with safinamide as add-on to levodopa (post-period)
    Evenamide

    Evenamide met Phase IIa study objectives of good tolerability, safety, and preliminary evidence of efficacy as an add-on therapy for the treatment of patients with chronic schizophrenia
    Encouraging results presented at International Congress on Schizophrenia Research and at the European College of Neuropsychopharmacology Congress
    Meetings with a number of health authorities confirmed the acceptance of preliminary evidence of efficacy and of the design of two potentially pivotal studies, which are key components of the Phase III development program that is expected to commence towards the end of 2018
    Sarizotan

    Newron amended its “Sarizotan Treatment of Apneas in Rett Syndrome” (STARS) study to include Rett syndrome patients under 13 years of age, following FDA approval of the extension
    STARS study launched at trial sites in Italy, Australia, the UK and India
    Poster presented at 22nd Annual International Meeting of the International Society for Pharmaeconomics and Outcome Research on the largest and most comprehensive qualitative study to examine burden of Rett syndrome
    Burden of Disease Advisory Board Meeting and Thought Leadership Roundtable at European Rett Congress

  10. #10

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    Corporate

    Newron raised CHF 27.0 Million in a private placement of new shares
    Coverage of Newron stock initiated by Bank Vontobel and Kempen (post end of reporting period)
    Stefan Weber, Newron’s Chief Executive Officer, commented:

    “We are delighted by the progress that has been made both with our commercial product, Xadago and with our pipeline products during 2017. In 2018, we hope Xadago will be made available to patients in additional countries and territories. We are excited by the potential of both sarizotan and Evenamide and we look forward to their continued development. We believe their progression has the potential to strengthen our position as a leader in the CNS disease area. With a strong balance sheet, we anticipate our funding will take us to 2020, beyond expected key value inflection points. Newron also continues to evaluate non-dilutive funding opportunities”.

    Xadago®: Launch in the US and additional study to confirm benefits in LID

    In 2017, Xadago (safinamide) received FDA approval and was launched in the United States (US). It is the first New Chemical Entity approved in more than a decade for the treatment of Parkinson’s disease (as an add-on therapy for patients currently taking levodopa/carbidopa and experiencing so-called “OFF” episodes) and an important milestone for the Company. As a result of the approval by the FDA, Newron received a EUR 11.3 million milestone payment from its partner Zambon. In addition to the product’s launch in the US, Xadago was also made available by Zambon in Portugal, Austria and Finland, in 2017. Dossiers for marketing authorization of Xadago in Brazil and Colombia have been submitted by Zambon, and are under review by the relevant authorities.

    Furthermore, Zambon announced partnerships for Xadago with Seqirus in Australia and New Zealand, with Valeo Pharma in Canada, and, post period, informed Newron of its partnership with Medison Pharma in Israel. Seqirus has filed for marketing authorization in Australia and will undertake the commercialization of Xadago in Australia and New Zealand. Valeo Pharma has filed for marketing authorization in Canada and will be responsible for all further regulatory, sales and marketing, quality, and distribution activities in Canada.

    In addition, Newron’s partner in Asia, Meiji Seika, entered into a collaboration with Eisai for the development and commercialization of Xadago in Japan and key territories in Asia. Post-period, both announced that the primary endpoint was met in a Phase II/III clinical study with safinamide as an add-on to levodopa in patients with Parkinson’s disease. Consequently, Meiji plans to file for marketing authorization of safinamide with the Japanese Pharmaceutical and Medical Device Agency (PMDA) during 2018.

    A study to demonstrate the anti-dyskinetic effect of Xadago in Parkinson’s disease patients with Levodopa Induced Dyskinesia (LID) is scheduled to start in the second half of 2018 and is being planned together with the Company’s partner Zambon.

    Newron’s CEO Stefan Weber commented: “We are confident that the prior evidence of Xadago’s benefits in Parkinson’s disease patients with Levodopa Induced Dyskinesia will be confirmed, providing a treatment option for more patients and an enhanced commercial opportunity.”

    Evenamide: Design of two potentially pivotal studies underway

    Newron has also made strong progress with Evenamide, the Company’s innovative drug candidate with a novel mechanism of action, offering a new treatment option for patients suffering from schizophrenia. In 2017, a Phase IIa study demonstrated evidence of efficacy in significantly improving symptoms of psychosis compared with placebo, when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia. It also indicated that Evenamide is a highly selective sodium channel antagonist, and does not interact with any of the neurotransmitters, enzymes, or transporters affected by most antipsychotics. Ravi Anand, Newron’s Chief Medical Officer, commented: “These results, together with earlier preclinical results, which indicated inhibition of stimulated release of glutamate by Evenamide, have been discussed with a number of health authorities; meetings with the EMA’s CHMP and the FDA are being scheduled for Q2 2018.”

    Newron intends to finalize the design of two potentially pivotal efficacy studies within the Phase III development program, which is expected to commence towards the end of 2018, after receiving CHMP and FDA input. The first study will enroll patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and the second study will be performed in treatment-resistant schizophrenia patients not responding to the antipsychotic drug clozapine. It is estimated that this latter cohort consists of approximately 20,000-35,000 patients in the US and potentially provides a separate indication for Evenamide that Newron may commercialize on its own.

    Sarizotan: Expanded STARS study and poster presentation

    The development of Newron’s Rett syndrome candidate sarizotan has been advancing in 2017. The ongoing “Sarizotan Treatment of Apneas in Rett Syndrome” (STARS) study was expanded, with patients as young as six years now included in the trial. This expansion was approved by the US FDA and health authorities in Italy, Australia, the UK and India. Currently, patients are recruited in 15 centers in the US, the UK, Italy, India and Australia.

    In addition to the clinical development of sarizotan, Newron continues to advance its partnership with the Rett community. Newron initiated the first qualitative study to examine the burden of Rett syndrome on individuals and their caregivers with the help of an international panel of experts. A poster entitled “Burden of Disease in Rett Syndrome: A Qualitative Analysis” was presented at the 22nd Annual International Meeting of the International Society for Pharmacoeconomics and Outcome Research, showing the results of a targeted literature search and preliminary findings from a qualitative interview study aimed at describing the burden of Rett syndrome on individuals and their families.

    Initiative for standardized methodology to assess the value of orphan drugs

    In November 2017, at the European Rett Syndrome Congress in Berlin, Newron held a Burden of Disease Advisory Board Meeting, at which the questions for inclusion in a survey that will be distributed internationally to caregivers and allied healthcare professionals were agreed. Alongside the Congress, the Company hosted a thought leadership roundtable discussion to discuss the need for a standardized methodology to assess the health economic value of orphan drugs treating rare diseases that impact multiple organ systems. Although, by definition, only a small number of patients suffer from each rare disease, collectively they present significant medical and socio-economic issues. "We believe that improved methods for assessing the value of orphan drugs will enable better development of drugs to treat these diseases. Improving these methods is an area of research and interest, which Newron will be pursuing further in 2018", emphasizes Newron’s VP Commercial Affairs Dennis Dionne.

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