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Posts tagged with "Regulatory Affairs"

  • Drug Industry History

    The Early FDA

    Here’s a short video history of the FDA, courtesy of BioCentury TV. The early days, especially Harvey Wiley and the “Poison Squad”, are truly wild and alarming by today’s standards. But then, the products that were on the market back then were pretty alarming, too. . . Read More
  • Clinical Trials

    Drug Repurposing

    A reader has sent along the question: “Have any repurposed drugs actually been approved for their new indication?” And initially, I thought, confidently but rather blankly, “Well, certainly, there’s. . . and. . .hmm”, but then the biggest example hit me: thalidomide. It was, infamously, a sedative and remedy for mornin… Read More
  • Cancer

    Incomprehensible Drug Prices? Think Again.

    There’s a post by Peter Bach, of the Center for Health Policy and Outcomes, that’s been getting a lot of attention the last few days. It’s called “Unpronounceable Drugs, Incomprehensible Prices”, and you know what it says. No, really, you do, even if you haven’t seen it. Too high, unconscionable, market can’… Read More
  • Business and Markets

    Allergan Twists and Turns

    It’s getting nasty over at Allergan. They’re still trying to fight off a takeover attempt by Valeant, making the case that the company’s R&D efforts are not a waste of money (which, only slightly simplified, is the Valeant position regarding every company they’re taking over). But Allergan’s had a lot of trouble g… Read More
  • Clinical Trials

    The Virtual Clinical Trial: Not Quite Around the Corner

    Here’s one of those “Drug Discovery of. . .the. . .Future-ure-ure-ure” articles in the popular press. (I need a reverb chamber to make that work property). At The Atlantic, they’re talking with “medical futurists” and coming up with this: The idea is to combine big data and computer simulations—the kind an engi… Read More
  • Clinical Trials

    Stem Cells: The Center of “Right to Try”

    I wanted to point out an excellent editorial on the whole “Right to Try” issue at Nature. The authors note correctly that stem cells are the therapeutic area where these battles are being fought most often, since their regulatory status (particularly with any sort of autologous cell treatment) is sometimes unclear, the number of possibl… Read More
  • Clinical Trials

    Right To Try: Here We Go

    At what point should an experimental drug be made available for anyone to try it? The usual answer is “Unless you’re enrolled in a clinical trial, then not until it’s no longer an experimental drug”. There’s always compassionate use, but that’s a hard topic to deal with, and one that has a different answer for… Read More
  • Regulatory Affairs

    The Reasons for Failure at the FDA

    Here’s a good retrospective in JAMA, from the FDA, about what’s happened when the agency has rejected a new molecule entity (NME). The authors look over the data set from 2000-2012 to see what the most common reasons for trouble were, and what happened after that in each case. Overall, 302 new molecules were submitted… Read More
  • Regulatory Affairs

    The 2013 Crop of New Drugs

    Here’s Lisa Jarvis’s roundup of the 2013 drug approvals (PDF version). There’s also a list of notable late-stage clinical failures, and unfortunately, these tended to be potentially bigger drugs than the ones that got through last year. I have to wonder if the structures included along with the chart were chosen especially to high… Read More
  • Clinical Trials

    PTC’s Latest Ataluren Woes

    I wrote here about PTC Therapeutics and their drug candidate for Duchenne muscular dystrophy (ataluren, PTC124). Opinion has been divided, to put it mildly, about how it works and whether it works at all. Well, the saga continues. The company is having a rough time with that program these days, though. PTC applied to the… Read More