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Posts tagged with "Clinical Trials"

  • Clinical Trials

    Rules for Modern Drug Development

    Here’s Robert Plenge at Merck, writing in Science Translational Medicine on what currently looks like the best way we have to do drug discovery. I’ll freely admit that I didn’t expect this article to be as good as it is (a lot of things with titles like this are crap). But he’s done a good… Read More
  • Business and Markets

    Opdivo: Euphoria to Panic

    We’ve gotten used to seeing one success after another in the cancer immunotherapy field, so this morning’s news is a bit of a shock: the Bristol-Myers Squibb flagship antibody, Opdivo (nivolumab), seems to have completely missed its endpoints in a trial in non-small cell lung cancer patients. And this was in over 500 patients who… Read More
  • Aging and Lifespan

    A Shady Trial?

    The “young blood” research field is moving right along, but there are reasons to wonder about some of the directions it’s moving in. I’m referring, of course, to the results that have shown profound effects of younger plasma on older animals, and the big question is what the effects are on older humans. The Stanford… Read More
  • Alzheimer's Disease

    TauRx Reports on Their Alzheimer’s Drug. Unfortunately.

    It’s been a while since we heard from TauRx, the company that’s been developing an unusual Alzheimer’s therapy targeting tau protein instead of amyloid. They released interesting Phase II data some time ago, but they’ve been improving their formulation and going into a larger, longer Phase III, which is what anyone working… Read More
  • Clinical Trials

    Valeant Sure Picks the Winners

    You may remember brodulamab, the anti-IL-17-receptor antibody (update: fixed a mistake in the mechanism) that was under development by Amgen and AstraZeneca for psoriasis (among other indications). But it was abandoned last year when the clinical trials showed “suicidal ideation” turning up. But those canny market-driven Valeant folks p… Read More
  • Clinical Trials

    How Much Clinical Research Is Useful?

    John Ioannidis is back with an article titled “Why Most Clinical Research Is Not Useful”. (Thanks to Cambridge MedChem Consulting for the mention of it). His emphasis here on clinical work comes from his own admission that improving the efficiency of early-stage research is much harder to do, since it can lead in so many directions… Read More
  • Clinical Trials

    Sage Therapeutics: Time For Some Real Numbers Now

    I wrote last summer about Sage Therapeutics and their strange four-patient open-label depression study. Well, now they’re back with a placebo-controlled trial in the same indication (post-partum depression), and it’s very much one of those on-the-one-hand things. Because on that one hand, the data look very good indeed. There’s a… Read More
  • Cancer

    CAR-T Deaths Cannot Be Good

    Late yesterday afternoon, Matthew Herper broke the news that Juno Therapeutics had had their CAR-T leukemia trial put on hold after three patient deaths. That’s bad news no matter how you look at it, even for their competitors. It’s too early to say for sure if Juno will be slowed in its path to market. Read More
  • Cancer

    Can’t Shake Failure Yet

    From the new Endpoints site, here’s a roundup of the worst moments in the clinic for drug development in the first half of 2016. Several of them were covered at the time here as well, but there the whole list is worth a look, because it illustrates the many ways that big trouble can hit. Read More
  • "Me Too" Drugs

    PARP Inhibitors Come Through

    PARP (poly ADP-ribose polymerase) inhibitors have had a rough time of it in the clinic. Sanofi had one (iniparib) fail, but it later turned out, embarrassingly, that it wasn’t really a PARP inhibitor at all (update: more on this here). AstraZeneca had a legitimate one fail as well (olaparib). Merck got out of the area… Read More