Skip to Content

Posts tagged with "Regulatory Affairs"

  • "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
  • Regulatory Affairs

    Sarepta’s Day at the FDA

    I last wrote about Sarepta and eteplirsen, their proposed therapy for Duchenne muscular dystrophy, here. They’re in front of an FDA advisory committee today, and it will be very interesting to see how it goes. The patients (and their families) are very, very much in favor of approval, as you’d imagine, but the data supporting such… Read More
  • Business and Markets

    The Treasury Wins Over Pfizer. Of Course.

    So the Pfizer-Allergan deal has collapsed. The two companys are walking away from it, since under the new rules announced by the Treasury Department, there would be no tax advantages. And this one was all about the taxes – there was no particular drug development or business rationale other than saving a big bucket on… Read More
  • Business and Markets

    Don’t Try to Leave

    The proposed Pfizer-Allergan deal has entered a new stage, and how. You’ll recall that Pfizer has been shopping for years for a way to change its US tax situation, and a merger with Dublin-domiciled Allergan looked like the one that would finally work out. Until last night, that is. That’s when the US Treasury unveiled… Read More
  • Regulatory Affairs

    Closer Looks at Priority Review Vouchers

      I wrote a bit about Priority Review Vouchers at the FDA back in December, and there are some publications looking over the whole field that I wanted to mention (thanks to @AndyBiotech on Twitter for the pointer to these). For example, I missed this JAMA article from three authors at Harvard Medical School. They believe that… Read More
  • Drug Prices

    Update on Catalyst Pharmaceuticals

    I wanted to update readers on Catalyst Pharmaceuticals, whom I first wrote about here. They’re the ones who have been planning 3,4-diaminopyridine (DAP), a therapy for a rare disorder called Lambert-Eaton Myasthenic Syndrome which is currently being provided at no cost, and run it through the FDA’s regulatory process so as to get market… Read More
  • Drug Prices

    The AG of Massachusetts Has No Chance Against Gilead

    Drug prices too high? Why not just have the state Attorney General’s office set them for you? That’s what I’m taking away from this story. Maura Healy, AG of Massachusetts, is firing a warning shot at Gilead over the pricing of their HepC drugs. Her office is apparently considering whether Gilead is engaging in an… Read More