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Posts tagged with "Regulatory Affairs"

  • Biological News

    Genetic Variation Gets More Real All the Time

    This study goes firmly into the file marked “You never could have done this one a few years ago, sonny”. We already know that there’s genetic variation in every population and in every individual. And we know that a large number of marketed drugs (about a third of them) target G-protein coupled receptors (GPCRs). But… Read More
  • Clinical Trials

    Not How You Speed the Process Up, Exactly

    Now, this truly does not sound like the way to run a clinical trial. Dr. William Halford of the Rational Vaccines company invited 20 patients to St. Kitts for a trial of a putative herpes vaccine. The consent forms explicitly stated that this was done to evade the jurisdiction of the US Food and Drug… Read More
  • Clinical Trials

    When Small Trials Convince

    This is a good piece by Bruce Booth in Forbes, and it points out something that’s changing in the biopharma landscape. Readers will have noticed over the years here the occasional eye-rolling at companies that run underpowered clinical trials and go to the FDA hoping for the best. That’s not a good place to save… Read More
  • Pharmacokinetics

    Fewer Flashy Drug Delivery Papers, Please

    Drug delivery – now that’s a tricky field. The variety of drug substances is large, and the ways that they’re taken up and distributed in living systems are many. And we’d like control over the process, which we don’t often have. A typical kid’s question is “How does the aspirin know where the headache is?… Read More
  • 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
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