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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 The FDA Issues Draft Guidance for Biosimilars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:
    Obesity drug approvals are like buses…
    Post date:
    3/27/2015 2:53:49 PM
    Post Summary:

    Contributors: Tim Blackstock
    Topics: Obesity, Orexigen, Mysimba, Contrave, Saxenda, "Novo Nordisk", "Takeda Pharmaceutical", approvals

    …there are none for ages and then several come along at once. In the United States, physicians managing obese patients were essentially only able to prescribe Roche’s Xenical (orlistat) and phentermine (and other noradrenergic anorectic agents) for years, and then Arena Pharmaceutical/Eisai’s Belviq (lorcaserin) and Vivus’s Qsymia (phentermine/topiramate fixed-dose combination [FDC]) were approved in June and July, respectively, during 2012.


    Post title:
    Sweet results for Contrave leave a bad taste in the mouth
    Post date:
    3/11/2015 11:26:21 AM
    Post Summary:

    Tim BlackstockContributor: Tim Blackstock
    Topics: Obesity, Contrave, Mysimba, Orexigen, FDA, Regulatory Approval, Cardiovascular Outcomes

    Orexigen has made interim data from the LIGHT study publically available in a financial report; details can be viewed here.
     


    Post title:
    Creating oral versions of injectable therapies for chronic diseases – a “win-win-win” concept
    Post date:
    3/6/2015 11:13:08 AM
    Post Summary:

    Stefanie MatlokContributor: Stefanie Hoffart
    Therapeutic area: Cardiovascular and Metabolic Disorders

    Novo Nordisk recently announced the first positive Phase 2 results for an oral GLP-1 analogue. Oral therapies are typically utilized in the early lines of therapy for type 2 diabetes, but as the disease progresses more aggressive treatment is required so patients can end up on multiple oral medications.


    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.


    Post title:
    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.

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