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Posts tagged with "Regulatory Affairs"

  • 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
  • Clinical Trials

    Are Things Getting Any Better in the Clinic?

    Here’s an updated look at clinical success rates in the biotech industry, from the BIO industry organization. They’re looking at only company-sponsored programs aimed at FDA registration, nothing investigator-sponsored, and it’s a big data set: This is the largest study of clinical drug development success rates to date. Over the… Read More
  • Clinical Trials

    Nothing Works (Yet) Against Duchenne Muscular Dystrophy

    Duchenne muscular dystrophy (DMD) has always been considered a hard disease to come up with a treatment for. And how we have plenty of evidence to back up that belief: it’s catastrophically hard. Over the last few years, we’ve seen rival therapies go through all kinds of wrenching twists and turns. Prosensa was developing drisapersen… Read More
  • Drug Development

    AstraZeneca’s Nasty Surprise

    Something got severely screwed up here. That’s the only conclusion I can draw after seeing AstraZeneca get a Complete Response Letter (CRL) from the FDA for their drug ZS-9. They bought ZS Pharma last year for this drug, paying an armrest-gripping $2.7 billion for the privilege, and now get to watch it shot down. ZS-9… Read More