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Posts tagged with "Regulatory Affairs"

  • Alzheimer's Disease

    The Aducanumab Approval

    As the world knows, the FDA approved Biogen’s anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I think this is one of the worst FDA decisions I have ever seen, because – like the advisory committee that reviewed the application, and like the FDA’s own statisticians – Read More
  • Alzheimer's Disease

    A Brief Note About Aducanumab

    There’s a big FDA decision coming up in the next few days: whether or not to approve the Biogen antibody for Alzheimer’s (aducanumab). I’ve had several people ask me what I think about this, and I can only refer them to what I said in 2019 and what I said late last year as well. Given… Read More
  • Covid-19

    Waiving IP

    The announcement by the Biden administration about waiving IP rights to the coronavirus vaccines obviously calls for some comment. Keep in mind that I have been doing research in the pharma industry for over 30 years now, so my viewpoint is obviously going to be affected by that, for better and for worse. With that… Read More
  • Covid-19

    Brazil Rejects the Gamaleya Vaccine

    We have two pieces of news about the Gamaleya Institute’s “Sputnik-V” vaccine today. Neither of them are going to be enjoyable to go into. First off, many may have heard that the Brazilian regulatory authorities had a hearing yesterday to see if this vaccine would be approved for use there. They have turned it down… Read More
  • 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