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Posts tagged with "Regulatory Affairs"

  • Business and Markets

    The 21st Century Cures Act: A Giant Piñata

    So we have another whopper of a piece of health care legislation before us in the 21st Century Cures Act. I believe that this one runs over 1,000 pages, so anyone who tells you that they’re on top of the whole thing is probably bluffing. Bills like this are giant piñatas, and all kinds of stuff… Read More
  • Business and Markets

    If Design Govern in a Thing So Small

    It will not have escaped the notice of most readers of this site that biopharma stocks have been up strongly since the election. I don’t recall anyone predicting that, but (like most predictions) it works pretty well in hindsight. I think that investors are betting on new corporate tax laws that will make it easier… Read More
  • Regulatory Affairs

    Act Now And We’ll Throw In This Dead Arachnid

    I have a couple of bad-behavior stories today. The first (via ChemJobber’s Twitter feed) is from the FDA. They were inspecting – well, OK, trying to inspect – a Japanese facility owned by Nippon Fine Chemical, supplying APIs (active pharmaceutical ingredients/intermediates) to both the US and Japanese markets. (Readers outside the… Read More
  • Business and Markets

    China’s Internal Drug Market: A Mess

    This story has been making the rounds the last few days, and it’s interesting on several levels. A report in the Chinese newspaper Economic Information Daily says that the Chinese SFDA (State Food and Drug Administration) has been conducting a review of Chinese clinical trial practices, and after reviewing 1,622 trials has found that most of… Read More
  • Business and Markets

    Pfizer Says They Won’t Break Up

    Pfizer has been mulling over the idea of turning into at least two Pfizers for a long time now, but they’re out with an announcement this morning that they’ve decided that their current structure is the one that will help them be the best Pfizer that they can be. That’s going to disappoint a lot of… Read More
  • Regulatory Affairs

    Sarepta Gets An Approval – Unfortunately

    Sarepta got approval yesterday for their Duchenne muscular dystrophy therapy, Exondys (eteplirsen), after many, many twists and turns at the FDA. (When you consider that the advisory committee meeting on this was back in April, you get the idea). I can recommend this summary at Endpoints for what’s gone on with this decision, which has… Read More
  • Regulatory Affairs

    Label the Label Labels

    Here’s a (by now) little-known bit of pharma history, specifically for the companies that had sites in New Jersey. Back around 1990-91, the state passed a “Right to Know” law about chemical labeling. As I understand it, the idea was that any facilities that stored chemicals had to clearly label them with identifiers like the… Read More
  • Clinical Trials

    Valeant Sure Picks the Winners

    You may remember brodulamab, the anti-IL-17-receptor antibody (update: fixed a mistake in the mechanism) that was under development by Amgen and AstraZeneca for psoriasis (among other indications). But it was abandoned last year when the clinical trials showed “suicidal ideation” turning up. But those canny market-driven Valeant folks p… Read More
  • Current Events


    I’ve been thinking about “right to try” laws, the ones that are trying to open up access to not-yet-approved drugs for patients who wish to take their chances with them. There are a lot of practical considerations that bear on this idea (differences with existing “compassionate use” programs, effect on clinical trial e… Read More
  • "Me Too" Drugs

    Isotope Labeling For Fun and Profit

    Here’s an article on a company called Molecular Isotope Technologies, and their bid to “revolutionize the drug industry”. From the name, you might expect that this is another deuterium-for-proton idea, and you would say to yourself “But that’s already been done”. But read on. The company is perhaps better known b… Read More