Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine. All content is Derek’s own, and he does not in any way speak for his employer.

By Derek Lowe

Posts tagged with "Regulatory Affairs"

• Clinical Trials

  The FDA’s Latest Actions and Problems

  1 June, 2018

  It’s been clear for many years now that some drug companies are abusing the “restricted distribution” idea to keep generic competitors from being able to enter their markets. That, in fact, was a basic part of Martin Shkreli’s entire business plan, but guess what? He was not the first person to think of doing that… Read More

• Clinical Trials

  Federal Right to Try

  25 May, 2018

  So it looks like a Right-to-Try bill is going to be signed into law. People who have been advocating this for years will now get a chance to see how it works out in practice – and in fact, I would encourage them to go ahead and put down some predictions about what they think… Read More

• Regulatory Affairs

  Kratom and the FDA

  8 February, 2018

  The FDA has made an announcement about kratom, a plant preparation (Mitragyna speciosa) that (depending on who you ask) is a drug of abuse or a way for people to get off of other drugs of abuse. Specifically, it’s used as a way to mitigate opioid withdrawal symptoms, which is reason enough to wonder if it… Read More

• Clinical Trials

  A New Look at Clinical Success Rates

  2 February, 2018

  Andrew Lo of MIT and his co-workers have published a really interesting paper on clinical trial probability-of-success numbers. It appears to be the largest such effort yet: In this article, we construct estimates of the POS and other related risk characteristics of clinical trials using 406 038 entries of industry- and non-industry-sponsored trial… Read More

• Business and Markets

  Hospitals Making Drugs?

  19 January, 2018

  This story from the New York Times got a lot of attention yesterday, and understandably so. It’s fundamentally about the shortage of some generic drugs, a problem that’s been with us for some years now in one form or another. My own belief is that much of this is a regulatory problem, and I note… Read More

• Biological News

  Genetic Variation Gets More Real All the Time

  18 December, 2017

  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

  14 November, 2017

  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

  8 November, 2017

  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

  2 November, 2017

  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

  23 October, 2017

  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