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Posts tagged with "Clinical Trials"

  • Clinical Trials

    Drug Dosing

    First in humans! That’s a big step for a drug project – you’ve identified a clinical candidate with enough potency, selectivity, etc. to be a plausible drug, you’ve made it past toxicity testing (always a black-box cross-your-fingers exercise), and you’ve figured out a way to dose the stuff in human subjects. But how d… 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
  • Clinical Trials

    Opening the Lid on Sarepta’s Drug Approvals

    Let’s talk Sarepta. And FDA approval, because you can’t bring up that company without immediately starting a regulatory affairs argument. I was not happy when their initial exon-skipping therapy (Exondys, eteplirsen) for Duchenne muscular dystrophy was approved in 2016, because I thought that the efficacy data were simply not strong eno… Read More
  • Academia (vs. Industry)

    Getting Around to Reporting Clinical Data, Real Soon Now

    Science has an interesting report on the publication of clinical trial results. Some readers will recall similar efforts from 2015 and 2017/2018 in the US and Europe; this is actually a follow-up by one of the same US authors. It should actually be a dull report, because the requirements for such disclosure are clear. The rules… 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
  • Business and Markets

    Another Shot at Major Depression Fails

    This is a big day for clinical trial data, and unfortunately it didn’t get off to a very good start. Everyone is waiting for more data on Biogen’s Alzheimers program later today, but another anticipated trial has already read out. Sage Therapeutics made quite a few headlines in 2017 and 2018 when their trials of… 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

    The Return of Aducanumab

    When last heard from, Biogen and Eisai’s aducanumab (another amyloid-targeting antibody for Alzheimer’s) had failed in Phase III and the whole effort was being terminated. Then came Tuesday. Biogen then startled everyone by announcing that a review of the clinical data had convinced them that the drug had actually worked – or at l… Read More
  • Clinical Trials

    An AI-Generated Drug?

    There were some headlines the other day about the “first AI-discovered drug”, so that should send us to the work in question to see what’s going on. The company in question is called Deep Genomics, and here’s what its founder has to say: “Making drugs has traditionally been a gambling game. Big Pharma is throwing… Read More
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