Skip to main content
Menu

Posts tagged with "Alzheimer’s Disease"

  • 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
  • Alzheimer's Disease

    Lilly’s Alzheimer’s Data

    That’s a post title that I could have used eight or ten times over the lifetime of this blog – Eli Lilly has been hammering away at Alzheimer’s for a long time now. They have yet another anti-amyloid antibody study out this week, and (as has happened over and over in this area) it as… 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
  • Alzheimer's Disease

    Congo Red

    Many roots of organic chemistry, and of medicinal chemistry in particular, often originate in what might seem like an unlikely place: the dyestuff industry of the late 19th century. I had already known this to some degree, but writing the historical vignettes in The Chemistry Book really brought it home to me. And if you… Read More
  • Alzheimer's Disease

    A Prospective Alzheimer’s Trial Reports

    For the past several years, a clinical trial from Washington University (St. Louis) has been underway in people with genetic mutations that lead to early-onset Alzheimer’s. The Dominantly Inherited Alzheimer’s Network (Trials Unit), DIAN-TU, has been dosing 194 such patients with one of two anti-amyloid antibodies, either Lilly’s… Read More
  • Alzheimer's Disease

    They Don’t Know

    Well, Biogen has released more data on its Alzheimer’s antibody, aducanumab. The people (like me) who were doubtful (or worse) that they had enough to make a case for FDA approval remain doubtful. And the people (there are some) who think that it’s approvable haven’t changed their minds, either, from what I can see. Frankly… Read More
  • Alzheimer's Disease

    More, Unfortunately, on the Chinese Alzheimer’s Drug Approval

    I wrote yesterday about the surprise decision by the Chinese regulators to allow a new Alzheimer’s drug on the market. That drug (GV-971) was developed by Green Valley Pharmaceuticals, a company (and a drug, for that matter) that frankly I had never heard of. But other people have heard of both, and they’ve been contacting… Read More
  • Alzheimer's Disease

    A New Alzheimer’s Approval in China

    Edit: tomorrow’s post will be on this subject too, with some information that I’ve been learning today. . . Today brought the rather surprising news that the Chinese government’s National Medical Product Administration (NMPA) has approved a new Alzheimer’s drug. What’s more, it’s an unusual (and unexpected) mecha… Read More
  • Alzheimer's Disease

    Amgen and Neuroscience

    So Amgen has exited the neuroscience area, with a good-sized round of layoffs at their research site Cambridge. The company has a migraine drug (Aimovig) that they’ll continue to support, and they’ll stick with their existing clinical programs, but it looks like all the early-stage stuff is gone. What does this mean? Not as much… Read More