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Posts tagged with "Clinical Trials"

  • Clinical Trials

    Moderna’s Vaccine Efficacy Readout

    As expected, we have more vaccine news this morning. And the news is good. Moderna reports that their own mRNA candidate is >94% effective (point estimate), with 95 total cases in the trial to date, split 90/5 between the control group and the vaccinated group. 11 of those were severe infections: all 11 in the… Read More
  • Clinical Trials

    Lilly’s Monoclonal EUA

    I’ve been meaning to write about what has to be called a regulatory mystery. Eli Lilly obtained an Emergency Use Authorization for its monoclonal antibody (bamlanivimab) against SARS-Cov-2, but (as detailed in this post) the dosage that they applied for was 700mg. Which is one-quarter of the dose that showed any efficacy against the primary… Read More
  • Clinical Trials

    The Latest Antibody Data From Lilly and From Regeneron

    We have a new paper in the NEJM from the Eli Lilly effort on monoclonal antibodies against the coronavirus. And there’s no reason not to be up front about it: it’s disappointing. This is the BLAZE-1 trial (mentioned in this recent post), which is studying non-hospitalized patients. It was another trial (ACTIV-3) where this antibody… Read More
  • Cancer

    Click Chemotherapy

    So here’s an ambitious idea that’s about to get a hearing in human clinical trials. A startup called Shasqi is using click chemistry as a drug delivery method, and they have a new manuscript on the idea here at ChemRxiv. The idea is this: you produce a modified version of a hyaluronate biopolymer, decorated with… Read More
  • Clinical Trials

    The SOLIDARITY Data

    OK, we have some more to think about this morning. The large SOLIDARITY trial from the WHO has reported more interim data on its investigation into repurposed drugs for the coronavirus pandemic. And some of this we already knew, but some of it’s a real surprise. One drug reported on is hydroxychloroquine. This showed no… Read More
  • Clinical Trials

    Another Vaccine Trial Halt

    The first advice is “Don’t panic”. You will have heard that last night J&J announced that their coronavirus vaccine dosing has been paused while they investigate an adverse event in the trial. And while you never like to hear that, considering the size of their effort, this sort of thing is likely to happen even… Read More
  • Clinical Trials

    J&J Vaccine Data

    We have more data on the J&J/Janssen coronavirus vaccine, which those keeping score at home will remember is an adenovirus vector candidate. It uses an obscure member of that virus family (Ad26) that very few people have ever been exposed to, as opposed to the ones where significant parts of the population might have pre-existing… Read More
  • Clinical Trials

    The Vaccine Protocols

    We now have the official clinical trial designs for the three biggest and most advanced coronavirus vaccine trials: Moderna, Pfizer/BioNTech and Oxford/AstraZeneca. Now, as for you, J&J, Novavax, Merck, and all the others that are pushing into efficacy trials as fast as possible – don’t think for a moment that you won’t be exp… Read More
  • Clinical Trials

    Monoclonal Antibody Data

    We have a bit of human clinical data from the Eli Lilly/Abcellera collaboration to make a monoclonal antibody therapy against the coronavirus. A full paper is coming soon, the press release says, but for now it looks like this is all we have to go on. It’s a mixed assortment of news. On the cheerful… Read More
  • Clinical Trials

    Serious Adverse Event Time

    Lots of uncertainty in the vaccine world today: as many will have heard, the Oxford/AstraZeneca trial in the UK, the US, and Brazil has been paused due to a serious adverse event. The New York Times, citing a source with knowledge of the event, reported last night that this was transverse myelitis. And Nature has… Read More