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Posts tagged with "Regulatory Affairs"

  • Business and Markets

    Mongersen Fails

    Readers may recall a post here last year about an odd trial of an antisense drug for Crohn’s disease. Celgene had acquired the drug (mongersen, GED-301) from Nogra Pharma of Ireland back in 2014 as a late-stage candidate, and for a while, things looked good. In fact, going back and reading the stories, you’d think that… Read More
  • Cancer

    A Painful, Unacceptable Lack of Data

    Okay, this paper is not going to make a lot of people happy. The authors are reviewing oncology approvals by the European Medicines Agency (EMA) from 2009 to 2013 – overall, there were 48 drugs approved for 68 indications, which sounds like good news. 24 of the 68 were approved with survival benefit shown in… Read More
  • Alzheimer's Disease

    Bad News – But Not the Unexpected Kind

    Yesterday was not a good day for small companies trying to get drugs to regulatory approval for tough diseases. You may well remember Axovant, a company that I’ve written about several times (most recently here). To recap, AXON was started by a fund manager, who bought a failed Alzheimer’s candidate off GSK, announced that they’d… Read More
  • Pharmacokinetics

    Adverse Events: A Look Under the Hood

    As most people know, there’s an FDA Adverse Event Reporting System, which is supposed to capture any sort of problems that turn up with approved drugs. Certainly if you have any kind of job in the industry, you know about it – every corporate training program includes a section about how if you hear about… Read More
  • Cancer

    The Keytruda Story

    This is a good history of Keytruda, the Merck immuno-oncology blockbuster, from David Shaywitz. Most big drugs have a tangled history, and this one is certainly not going to break tradition. As witness: It was discovered accidentally, by biotech scientists looking for drugs that would tamp down the immune response in patients with autoimmune diseas… Read More
  • Business and Markets

    Does An Insurance Company Really Want to Develop New Therapies?

    Via David Shaywitz on Twitter, I’ve been seeing comments from the insurance company startup Clover Health that raised my eyebrows a bit. The misalignment between existing health insurers and their customers is that insurers view customers in terms of annual income instead of customer lifetime value. This is where (Vivek) Garipalli believes Cl… Read More
  • Business and Markets

    Mylan Begins Harvesting the Crop It’s Sown

    There’s an interesting fight going on inside Mylan Pharmaceuticals. They, of course, are the longtime generic drug maker whose EpiPen prices have (understandably) made them a lightning rod for complaints about drug pricing in general. This New York Times article will give you the flavor of the company, and most unappetizing it is: To understa… Read More
  • Drug Prices

    Fixing the Generic Drug Process

    It’s very early in Scott Gottlieb’s tenure at the FDA, but I like what he has to say about generic drug approvals. Several times here, I’ve gone on about how a lot of the terrible pricing situations we’re seeing in generics are due to gaming of the regulatory system, and how the FDA could do… Read More
  • Clinical Trials

    I’m Surprised That They’re Surprised

    This article at the Wall Street Journal should not come as a particular surprise to anyone who followed the Sarepta/eteplirsen story over the last few years. But it’s a good overview of it, and it brings up several questions. (My own take on the drug approval is here – I didn’t think it should have… Read More
  • Alzheimer's Disease

    There Are Failures, You Know

    This exact point came up around here when we last discussed FDA reform, so it’s good to see it made at length in the New England Journal of Medicine. Remember solanezumab? That was the amyloid-targeting antibody that Eli Lilly kept on investigating in trial after trial, looking for some effect on Alzheimer’s. Last November, the final… Read More
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