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Posts tagged with "Regulatory Affairs"

  • 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
  • Business and Markets

    Marathon Pharmaceuticals Cashes Out

    You may recall Marathon Pharmaceuticals, the small company that announced plans to sell a long-used steroid treatment (Emflaza, deflazacort) in the US to Duchenne muscular dystrophy patients. The price was set to go up steeply, since the company was awarded years of market exclusivity by the FDA (under their program to reward orphan-drug indication… Read More
  • Regulatory Affairs

    Gottlieb At the FDA

    So today is when FDA Commissioner nominee Scott Gottlieb goes before the Senate committee, and it’s time for some thoughts on him, and some more thoughts on the FDA under the new administration. I purposely did not write about all the names that were mentioned for the post, because I just didn’t feel like spending… Read More
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