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Posts tagged with "Regulatory Affairs"

  • Covid-19

    The FDA Weighs Its First Coronavirus Vaccine

    Pfizer and BioNTech have a date on Thursday in front of an FDA advisory committee to review their vaccine data, and the briefing document is available for all to read (here’s the FDA’s own document as well). It’s very interesting stuff, and far more information than we’ve had so far. First off, safety. There continue… Read More
  • Clinical Trials

    Lilly’s Monoclonal EUA

    I’ve been meaning to write about what has to be called a regulatory mystery. Eli Lilly obtained an Emergency Use Authorization for its monoclonal antibody (bamlanivimab) against SARS-Cov-2, but (as detailed in this post) the dosage that they applied for was 700mg. Which is one-quarter of the dose that showed any efficacy against the primary… Read More
  • Alzheimer's Disease

    Aducanumab at the FDA

    So it’s finally time for Biogen to sit down with an FDA advisory committee to look at their proposed Alzheimer’s therapy, the anti-amyloid antibody aducanumab. I last wrote about it here, back in December, and you know what? I haven’t changed my mind a bit, because (1) no new data have emerged (none were expected) Read More
  • Covid-19

    The Vaccine Tightrope

    We’re getting closer to having to deal with a number of tricky issues around the first Emergency Use Authorizations (EUAs) for coronavirus vaccines. These have never quite come up in this way before, because (for one thing) EUAs for vaccines are relatively rare events, and (for another) we’ve never had so many simultaneous vaccine trial… Read More
  • Drug Industry History

    The Sad (and Saddening) History of Makena

    Longtime readers (and longtime drug industry folks!) may remember the Makena story from 2011. That is a progesterone ester drug that has been given to women at risk of preterm labor, and it came into the news when a small company called KV Pharmaceuticals used an FDA program that encouraged modern trials of older medicines… Read More
  • Covid-19

    Trouble at the FDA and CDC

    That title is the only way that I can describe the events of the last few days. Like so many other things this year, what we’re seeing now at the top of the drug regulatory structure is unprecedented, and not in a good way at all. Let’s recap. A few days ago, HHS Secretary Alex… Read More
  • Covid-19

    Vaccine Transparency

    I’ve been emphasizing for some time that our efforts to find and deploy a coronavirus vaccine have to be as transparent as possible to increase the chances for success. Recent events make that more clear than ever – and not in a good way. Update: Moderna has now published their complete clinical trial protocol, and… Read More
  • Covid-19

    Convalescent Plasma: The Science and the Politics

    I suppose that I’m going to have to say something about yesterday’s convalescent plasma announcement. First, the medical aspects: in my view, for what that’s worth, convalescent plasma is likely to be at least somewhat helpful to hospitalized coronavirus patients. I think that its safety profile is likely to be good as well, and I… Read More
  • Regulatory Affairs

    Not Approved Until It’s Approved

    For some years now, Biomarin has been working on a gene therapy for hemophilia A. That’s the form of the disease caused by a deficiency in Factor VIII, which is a necessary part of the blood-clotting cascade. Like many such conditions, it comes in a wide range of phenotypes. One group of patients (around 10%) Read More
  • Current Events

    The Politics of Hydroxychloroquine

    I had not been planning to return to the topic of hydroxychloroquine so soon, but here we are. This will not be a calm, measured blog post – fair warning. Yesterday, Dr. Rick Bright was pushed out of his post at HHS, where he was deputy assistant secretary for preparedness and response and director of BARDA… Read More