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Posts tagged with "Clinical Trials"

  • Clinical Trials

    Finger-Pointing at Celgene

    Just what is going on at Celgene? They’ve had some odd recent setbacks (such as as the failure of Mongersen), and another such acquisition, Ozanimod, had its filing recently rejected by the FDA. Several things about that incident were eyebrow-raisers – for one, it’s rare for a large, established company to get an outright refusal- Read More
  • Alzheimer's Disease

    An Alzheimer’s Statement

    “Despite this latest setback, Eli Lilly remains committed to plunging through this concrete wall headfirst. This is a sad day for our WallBreaker 2020 program, and some of our longtime head bashers will recall similar periods during SkullButt 2012 and ConcreteCracker 2016. But we continue to believe that the only way past this wall is… Read More
  • Cancer

    More Thoughts on AbbVie’s Rova-T Implosion

    I wrote a couple of months ago about the disappointing results that AbbVie had obtained with their cancer stem cell therapy “Rova-T” (rovalpituzumab tesirine) in small-cell lung cancer. This was the antibody-drug conjugate that they’d purchased from Stemcentryx – OK, let’s clarify that, they bought Stemcentryx out comp… Read More
  • Clinical Trials

    The FDA’s Latest Actions and Problems

    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
  • Cancer

    A Glioblastoma Vaccine? Not Yet.

    If you get your biomedical breaking news from the British press, you will have heard all about a very promising vaccine treatment for glioblastoma. (“Remarkably promising” – BBC. “Could add years” – The Guardian. And there’s the Daily Mail (naturally), The Independent, and more). That would be good news, b… Read More
  • Clinical Trials

    Federal Right to Try

    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
  • Alzheimer's Disease

    Merck’s BACE-Inhibitor Alzheimer’s Wipeout

    I mentioned last year that Merck’s BACE inhibitor trial for Alzheimer’s had been stopped for futility. Now here’s the full writeup in NEJM, and futility appears to have been le mot juste. There were two treatment groups (12 mg and 40 mg), and in neither one did the ADAS-cog or ADAS-ADL scores (scales for degree… Read More
  • Cancer

    Cancer Sequencing Hype And Reality

    This piece in Science says something that needs to be said louder and more publicly. If you live in the US, you’ve surely seen various cancer treatment centers talking about their personalized therapy plans, and especially how they’ll tailor things to your DNA sequence and so on. You would get the impression that we have… Read More
  • Cancer

    IDO Appears to Have Wiped Out

    We have the answer to a question posed here earlier this month. That was after the Merck/Incyte failure of a combination of Keytruda and Incyte’s IDO (indole 2,3-dioxygenase) inhibitor. That mechanism was supposed to increase T-cell activity, but the trial showed it to have no effect on Keytruda’s efficacy at all. Earlier IDO trials had… Read More
  • Clinical Trials

    Tighten Up Your Numbers!

    There’s clearly something wrong with the way that statistics get handled and interpreted in scientific studies, and there have been many warnings. But change in this area is a hard thing to bring about. Biocentury has a good interview with someone who can tell you about that, John Ioannidis, of scientific reproducibility fame. He’s rec… Read More
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