The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of lorcaserin (Lorqess, Arena). The vote was 18 in favor of approval, 4 against, and 1 abstention.
Pfizer will no longer aggressively market Lipitor (atorvastatin), its former crown jewel and the most lucrative pharmaceutical product ever. At the same time, generic drug manufacturer Ranbaxy posted record revenue for the last business quarter, growth fueled largely by sales of generic atorvastatin in the United States. Pfizer told the Wall Street Journal that it was abandoning…
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In an elderly population, when compared to men with atrial fibrillation, women with AF have a significantly elevated risk for stroke. This increased risk occurs regardless of warfarin use.
The FDA has posted briefing documents for Thursday’s meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to reconsider the new drug application for lorcaserin (Lorqess, Arena). The reviewers do not appear to have substantially altered their view of lorcaserin.
Primary PCI is widely recognized as the best early option for patients with ST-segment elevation myocardial infarction (STEMI). However, efforts to deliver primary PCI to the broadest possible population inevitably result in an increased number of false-positive activations of the cardiac catheterization laboratory. Now, a new study published in the Archives of Internal Medicine finds that…
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Roche announced today that it has ended development of dalcetrapib, its entry into the once-promising class of HDL-raising CETP inhibitors. A data and safety monitoring board recommended that the dal-OUTCOMES phase 3 trial be stopped due to a lack of clinically meaningful efficacy. The DSMB found no evidence of safety problems.
A new meta-analysis criticizes earlier work warning that the smoking-cessation drug varenicline (Chantix) poses increased cardiovascular risks. The analysis appears in BMJ. It was performed by researchers with no current ties to the drug maker, but one of whom had received a Pfizer investigator-initiated research award. The new analysis examined the risk of treatment-emergent serious…
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Boehringer Ingelheim failed to fully disclose data suggesting that one of its drugs, pramipexole, a dopamine agonist sold under the brand name of Mirapex, is associated with a significantly increased risk of heart failure, according to a recent news report. The drug, which was originally developed for the treatment of Parkinson’s disease, is now also used to treat…
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A new study offers “no compelling reason” to use warfarin instead of aspirin in heart failure patients who don’t have atrial fibrillation. In a paper published in the New England Journal of Medicine, Shunichi Homma and members of the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) study group report the results of a trial in which…
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The Centers for Medicare & Medicaid Services (CMS) issued on Tuesday its national coverage decision (NCD) for transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic…
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