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Posts tagged with "Regulatory Affairs"

  • 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
  • Business and Markets

    EQRx’s Challenge, And My Challenge to Them

    It’s time to talk about a new venture called EQRx. This has made quite a splash in the last few days at the JP Morgan investor conference, and it’s been launched by Alexis Borisy (involved with founding and/or helping run CombinatoRx, Foundation, Blueprint, WarpDrive Bio, Editas, Relay and others) with the aim of generating cheaper… 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
  • 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
  • Regulatory Affairs

    Tales From FDA Site Inspections

    It’s a summer Friday, so I’ll just send along this link to a story at Wired. It’s similar to this recent post, in that it details some of the ridiculous ways that small overseas manufacturers have tried to get around FDA site inspections. As a correspondent noted, though, the title of the Wired article isn’t… Read More
  • How Not to Do It

    Got It All Ready For You, Mr. FDA Inspector

    Many folks outside of this industry don’t realize that the FDA sends inspectors to drug manufacturing facilities in other countries. That might sound a bit odd, but agreeing to such inspections is in fact a condition of being able to sell pharmaceutical substances in the US (or to supply other companies that do). It’s a… Read More
  • Drug Prices

    Catalyst Sues the FDA

    So now we have another couple of twists in the Catalyst/Jacobus story (for background see these earlier posts). Jacobus, now that their version of amifampridine (3,4-diaminopyridine) has been approved by the FDA, has announced their price for the drug. And it’s definitely not the price they had before, which was free to the few people… Read More
  • Alzheimer's Disease

    A Missed Alzheimer’s Opportunity? Not So Much

    The Washington Post made quite a splash with this story about Pfizer, Enbrel (etanercept), and Alzheimer’s disease. There’s already been a lot of comment about it yesterday on Twitter and in some other venues, but I thought it might be useful to try to sum things up in an easily accessible place. Here we go: Read More
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