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DRugwatch Blog > February 2012

  • 2/23/2012 3:16:55 PM
    FDA Advisory Committee Get Behind Qnexa
    Contributor: Gideon Heap

    After a second FDA Advisory Committee meeting, Qnexa received a landslide 20-2 vote in favor of approval. Opinion seems to have turned in...
  • 2/14/2012 3:06:54 PM
    Finally! The FDA Issues Draft Guidance for Biosimilars
    Matt Kileen
  • 2/7/2012 5:51:17 PM
    Good News for Bydureon, but Bad News for Dapagliflozin
    Matt Kileen 2/7/2012 1:44:31 PM
    MDV3100 - Another Novel Agent Extends the Menu of Treatment Options for Prostate Cancer
    Matt Kileen

     

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    DRugwatch Blog

    Quick insight on intriguing drug market developments from Decision Resources’ analysts.

    Recent posts

    Post title:
    Next Steps for Vorapaxar: EU PAD Label and Antidote Development?
    Post date:
    2/17/2015 10:49:37 AM
    Post Summary:

    Stefanie Matlok Graeme GreeneWriiten by: Stefanie Hoffart and Graeme Green

    Topic: Cardiovascular

    On January 19, 2015, the European Medicines Agency (EMA) approved the thrombin receptor antagonist vorapaxar (Merck’s Zontivity) for secondary prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI), co-administered with acetylsalicylic acid (ASA) and, if necessary, clopidogrel.


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    Bococizumab: Late to Great? Dyslipidemia Déjà vu?
    Post date:
    2/12/2015 3:58:28 PM
    Post Summary:
    Tim BlackstockContributor: Tim Blackstock
    Topics: Cardiovascular

    The link between high low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) risk is well established, as is, the evidence showing that agents that reduce LDL-C can prevent CV events.

    Post title:
    Sandoz’s Biosimilar Filgrastim Scores Positive Recommendation from FDA Advisory Committee
    Post date:
    1/22/2015 3:44:26 PM
    Post Summary:
    Contributors: Anees Malik and Hristina Ivanova

    The unanimous recommendation by the Oncologic Drugs Advisory Committee (ODAC) for FDA approval of Sandoz’s biosimilar filgrastim (EP2006; Zarxio)–the first biosimilar filing to be accepted in the United States– moves the biosimilar product tantalizingly close to FDA approval. Oncology, Biosimilars, “Anees Malik”, “Hristina Ivanova”

    Post title:
    AstraZeneca’s Brilinta Meets Primary End Point in PEGASUS-TIM 54 Study
    Post date:
    1/15/2015 4:53:03 PM
    Post Summary:
    Conor WalshContributor: Conor Walsh

    AstraZeneca yesterday (January 14, 2015) announced that the Phase III PEGASUS-TIMI 54 study—a large-scale outcomes trial involving over 21,000 post-myocardial infarction (MI) patients—successfully met its primary efficacy end point. The company also reported that preliminary analysis did not reveal any unexpected safety issues. This study represents the first of several large studies that are set to complete over the next two years seeking to expand Brilinta’s (ticagrelor) label and drive sales growth.

    Post title:
    Cancer Drugs Funding in England is Flawed and Needs Reform
    Post date:
    1/14/2015 4:47:28 PM
    Post Summary:

    Contributor: Dan Roberts PhD

    In 2011, the UK government introduced the Cancer Drugs Fund (CDF) in England, which funds cancer drugs which have not been deemed cost-effective or have not yet been assessed by the National Institute of Health and Care Excellence (NICE).

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