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Posts tagged with "Clinical Trials"

  • Cardiovascular Disease

    What PCSK9 Is Telling Us About Drug Discovery

    Friday’s news about the real-world effects of PCSK9 drugs continue to reverberate. It’s worth going into the topic again, but from a wider view of genomics-driven medicine, because this is currently one of the biggest strategies for drug discovery in the industry. The reasoning behind this is pretty compelling. If you comb through the h… Read More
  • Business and Markets

    PCSK9: Real World Data Arrives, Unfortunately

    So, PCSK9. A wonderful story of genetics-based drug discovery, and a huge commercial opportunity. People with loss-of-function PCSK9 genes have very low LDL cholesterol, with no other ill effects, and people with gain-of-function mutations have chronically high cholesterol. That’s about as good as the validation gets, so a number of drug co… Read More
  • Business and Markets

    PARP Inhibitors Do It Again

    When we last looked in on the long-running saga of PARP inhibitors around here, Tesaro had posted excellent clinical results for their compound and re-invigorated the whole field. At the time, I wrote “It’ll be quite interesting to see the clinical results of the other PARP compounds in this light. You’d expect more differences to… Read More
  • Clinical Trials

    The Coming Landscape?

    Adam Feuerstein has an important list of companies (the “Gnarly Nine”) that will be going to the FDA soon. That process is always important for the companies involved, but these will serve as indicators of how the agency is dealing with the pressures for lowering the standards for drug approval. We don’t have a new FDA… Read More
  • Biological News

    Gene Therapy Needs Machines

    News came recently of an apparent cure, via gene therapy, of sickle-cell disease in a young patient (whose condition was refractory to hydroxyurea and the other standards of care). Blood-cell diseases are naturally one of the main proving grounds for things like this, since their stem cell populations are in easily localizable tissues and the… Read More
  • Cancer

    Nativis Lives the Life

    I sort of hate to bring them up again, but a reader sent along this link to a story at Geekwire, all about how there’s a Seattle company has raised $10 million for their new cancer-fighting device “that uses electromagnetic fields to mimic the effects of drugs” and yeah. . .it’s Nativis again. Here’s the… Read More
  • Alzheimer's Disease

    Guess How This Latest Alzheimer’s Trial Came Out

    Yes indeed, Merck announced last night that the first Phase III trial of their beta-secretase (BACE) inhibitor verubecestat was stopped because of futility. The monitoring committee, after looking over the data so far (the trial’s been running since 2012) concluded that there was no real chance of seeing efficacy. Merck had been enrolling pa… Read More
  • Clinical Trials

    Are Phase I Trials Ethical?

    It’s been a year since the clinical trial disaster in France that led to several participants being hospitalized with brain damage. Back in November, the New England Journal of Medicine had an article about the affair, summarizing what was known: The healthy volunteers described in this article participated in a phase 1 study of BIA… Read More
  • Clinical Trials

    I Do Hate To Tell You This, But. . .

    The timing of this report from the FDA is surely no accident, but it’s always a good time to think about this: the great majority of all drugs that enter clinical trials fail. They fail because they don’t do anyone any good, or because what good they might do is outweighed by some serious and… Read More
  • Alzheimer's Disease

    Vivek Ramaswamy’s Plans

    I last wrote about Vivek Ramaswamy in the context of his first company (Axovant). That one went public on the hopes for a retread Alzheimer’s drug to work out in Phase III, and if that sounds a little iffy to you, then join a fairly large club. Alzheimer’s is truly the approach-avoidance conflict writ large: from… Read More
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