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Posts tagged with "Clinical Trials"

  • Animal Testing

    Formally Undecideable

    A comment to the last post asked a good question, one that occurs to everyone in the drug industry early in their career: how many useful drugs do we lose due to falsely alarming toxicity results in animals? The answer is, naturally, that we don’t know, and we can’t. Not in the world as we… Read More
  • Clinical Trials

    A Question For the Crowd

    A quick request: I’d be interesting in hearing anyone’s experiences with any of the various adaptive clinical trial designs. I’m starting to work on an article on the subject, and thought it would be worth hearing some real-world experiences. Feel free to e-mail me or use the comments – thanks! Read More
  • Clinical Trials

    Access to Phase I Drugs: A Constitutional Right?

    So, as mentioned, the DC Circuit Court of Appeals came down with an interesting ruling (PDF available here). Here’s the background of the case, as summarized in the majority opinion: The Abigail Alliance for Better Access to Developmental Drugs (“the Alliance”) seeks to enjoin the Food and Drug Administration (“FDA”) f… Read More
  • Clinical Trials

    A Word to the Wise About TGN1412

    Here is the voice of someone who is under a great deal of stress and is not thinking clearly: Thomas Hunig, the German professor who founded the TeGenero company, said he still hoped the drug, TGN1412, could be brought to the market. He said he was devastated that the six men were taken ill but… Read More
  • Clinical Trials

    TNG1412: Was There a Warning?

    When everyone first heard about the TeGenaro/TGN1412 Phase I disaster, the immediate question was whether it could have been prevented. As mentioned before, the main problem I had was that the volunteers seem to have been dosed fairly quickly, rather than waiting longer to see how the first patient did. That alone would have contained… Read More
  • Clinical Trials

    Update on TGN1412

    I don’t often do updates on the weekends around here, but I wanted to point out this update from the BlackTriangle blog in the UK on the TGN1412 antibody trial. Anthony Cox has all the latest information from the medical and the British press, including many details which haven’t been mentioned in most reports. For… Read More
  • Clinical Trials

    No Immunity From Immunity

    (Update, March 17: See also later entry here. There’s been a severe problem with the first-in-man dosing of a new antibody in England. TeGenero, a small company in Germany, was testing their most advanced candidate, TGN1412, which is a monoclonal antibody against CD28. That’s a glycoprotein on the surface of many types of T cells… Read More
  • Clinical Trials

    But His Name Lives On. . .

    I currently have a piece up on the Medical Progress Today site, about what an 18th-century minister has to offer modern clinical trial design. (Statistics groupies will have already guessed the subject matter from that clue)! Read More
  • Clinical Trials

    The FDA Loosens Its Tie

    The FDA has released some new guidelines intended to make it easier to get drugs into the earliest stages of human trials. Considering how often we fail at those stages of development, anything that increases our number of shots on goal is good news. The first part of the new approach is a set of… Read More
  • Cardiovascular Disease

    An Expensive Way Back for Celebrex

    Pfizer’s going to pull out the stops and spend up to $100 million to try to show that their COX-2 drug Celebrex is worth it. And they’re going right to the source: the Cleveland Clinic. The study will be run by Steve Nissen, and he’s forbidding the investigators under him from accepting money from all… Read More