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Posts tagged with "Cardiovascular Disease"

  • Cardiovascular Disease

    Remember Vytorin? The Data Are Finally Coming.

    If you follow cardiovascular therapies, you’ll no doubt have seen that a bit of information has come out on Merck’s long, long, long-running IMPROVE-IT trial. That is the massive outcomes study for Vytorin, the combination of ezetimibe (the Schering-Plough cholesterol absorption inhibitor) and simvastatin (Merck’s early statin dru… Read More
  • Business and Markets

    A VC Firm Touts Its Successes – And Its Failures

    Here’s what sounds like a good idea from VC firm Index Ventures, from the latest issue of BioCentury (same one I referenced the other day). Like many others in the biopharma venture capital world, they’re trying to run the “killer experiment” as soon as possible, to see which ideas for new companies look solid. Unlike… Read More
  • "Me Too" Drugs

    Novartis Impresses Where Others Have Failed

    There is some good news from the clinic today. Novartis reported data on LCZ696, a combination therapy for congestive heart failure, and the results have really grabbed a lot of attention. (The trial had been stopped early back in March, so the news was expected to be good). This is a combo of the angiotensin… Read More
  • Cardiovascular Disease

    Ezetimibe In the Marketplace

    Several years ago, the Schering-Plough cholesterol absorption inhibitor (Zetia, ezetimibe) and its combination pill with simvastatin (Vytorin) were the subject of a lot of puzzled controversy. A clinical trial (ENHANCE) looking at arterial wall thickness in patients with familial hypercholesteremia had unexpectedly shown little or no benefit, altho… Read More
  • Cardiovascular Disease

    The Nasty Side of HDL

    A recurring theme here when I talk about cardiovascular drug discovery is how poorly we understand human lipidology. Surprise after surprise has followed on efforts to lower LDL and/or raise HDL, to the point that a person really has to wonder if the success of the statin drugs was a fluke. (And they could be… Read More
  • Cardiovascular Disease

    Merck Pulls One Out

    Merck’s vorapaxar, a thrombin antagonist that many had thought might never make it, has received a positive FDA advisory committee vote. I’m glad to see it – peripherally, I go way back with this compound (well, its ancestors), and I really had doubts that Merck could get things to fly. Anticoagulants are a very tricky… Read More
  • Cardiovascular Disease

    Nasty Odor as a Drug Side Effect

    If you read the publications on the GSK compound (darapladib) that just failed in Phase III, you may notice something odd. These mention “odor” as a side effect in the clinical trial subjects. Say what? If you look at the structure, there’s a para-fluorobenzyl thioether in there, and I’ve heard that this is apparently not… Read More
  • Cardiovascular Disease

    Dietary Fat and Heart Disease

    Here’s a provocative article at the British Medical Journal on cardiovascular outcomes and diet. Now, I free admit that the BMJ has a tendency towards controversialism, but I’m hardly in a position to throw stones. The author, Aseem Malhotra, says “Saturated fat is not the issue”. Human lipidology is a very complex field, an… Read More
  • Cardiovascular Disease

    The First PCSK9 Phase III

    Some long-awaited clinical data has appeared in the cardiovascular area: Sanofi and Regeneron have the first Phase III numbers for their PCSK9-blocking antibody alirocumab. (Here’s some background on this area from John LaMattina). This was a monotherapy trial, run head-to-head against Merck/Schering-Plough’s Zetia (ezetimibe). Patients… Read More
  • Cardiovascular Disease

    Clinical Trial Fraud Uncovered

    Hmmm. This article from Bloomberg says that the BMS/Pfizer anticoagulant Eliquis (apixaban), a Factor Xa inhibitor approved late last year by the FDA, was delayed for months because of misconduct in its Chinese clinical trials. (Its clinical trials had not been without incident even before this). Documents posted by the FDA have the details. Says… Read More
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