Skip to main content

Posts tagged with "Clinical Trials"

  • Clinical Trials

    Who Needs A Control Arm?

    Why, why would you run a trial of an antisense oligonucleotide without running a control group? That’s what everyone is asking Celgene after they reported results (which Adam Feuerstein correctly calls “uninterpretable”) for their GED-0301 (mongersen) against Crohn’s disease. The response rate was about 15%, but other Crohn… Read More
  • Clinical Trials

    Revusiran’s Failure Revisited

    I wrote about Alnylam’s recent clinical disaster here, where they had to stop a Phase III siRNA therapy trial against a rare amyloidosis with cardiac complications. A reader sends along the link to this 2008 paper that suggests a possible reason for the excess deaths seen in the trial. The authors studied a range of different siRNA… Read More
  • Cancer

    Keytruda vs. Opdivo: No Contest

    You don’t always get to see a head-to-head showdown like this one: Merck’s Keytruda (pembrolizumab) and Bristol Myers-Squibb’s Opdivo (nivolumab) were both the subject of presentations at the European Society of Medical Oncology conference, reporting on non-small cell lung cancer trials, and there doesn’t seem to be any doub… Read More
  • Clinical Trials

    Alnylam Blindsided

    Alnylam, the big name in RNAi therapeutics, had an awful day of it yesterday, and is having another one today. More may be on the way. Rivusiran, their Phase III candidate for transthyretin amyloidosis (ATTR), has been abruptly pulled from trials. This is particularly out of the blue, since the company had just completed enrollment… Read More
  • Clinical Trials

    Cathepsin K: A Promising Target Fades Out

    Here’s another one for the file of huge, long, costly drug discovery efforts that came to nothing (and that no one outside the business ever hears about): cathepsin K inhibitors. I remember “Cat K” from my own (relatively brief) days in osteoporosis drug work some years ago. It’s a target that’s been around since the… Read More
  • Alzheimer's Disease

    Does Axovant Have Any Hope in Alzheimer’s?

    Hey, remember Axovant? That’s the company that acquired a shelved Alzheimer’s candidate from GSK (intepirdine) and promptly went public in June of 2015 at what seemed a ridiculous valuation ($15/share, raising $315 million). People certainly made money on it, but jeez, the whole business really had a nasty look to it. The company’… Read More
  • Cancer

    Precision Oncology Isn’t Quite There Yet

    Here’s a gauntlet thrown down – let’s see how many people show up to the duel. Vinay Prasad has a piece in Nature titled “The Precision Oncology Illusion”, with the subhead saying “Precision oncology has not been shown to work, and perhaps it never will”. (Here’s Prasad earlier this year, with co-auth… Read More
  • Cancer

    Pancreatic Cancer Progress? Maybe

    There’s been a vast amount of work (and excitement) in the immunotherapy approaches to cancer in the last few years. Here’s a report on one that I’d missed: IMM-101, which is not directed to PD-1 or PD-1L1, not an engineered T-cell, or any of the other things that have been in the news. It’s a… Read More
  • Analytical Chemistry

    Not So Fast on the PD-L1 Comparisons

    We may have to rethink what we think about the recent trial in which Bristol-Myers Squibb’s Opdivo was ineffective in non-small cell lung cancer. The arguing has been about the status of the patients, specifically how much PD-L1 protein they were expressing. But writing in BioCentury, Stephen Hansen points out that comparing the various trial… Read More
  • 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