Drugs

Merck Mulls Anacetrapib NDA After Mixed Study

Responding to varying results in the REVEAL study of anacetrapib, Merck’s investigational cholesteryl ester transfer protein inhibitor, the company says it is reviewing the trial results with external experts and considering whether to submit an NDA to FDA. The study of 30,449 patients with atherosclerotic vascular disease receiving treatment with Pfizer’s Lipitor (atorvastatin) found that anacetrapib reduced the risk of major coronary events by 9% relative to placebo. However, a Merck statement says, a sub-study also showed that anacetrapib accumulates in adipose tissue with prolonged dosing.

Company officials say the benefit of adding anacetrapib to Lipitor was observed across multiple pre-specified subgroups. There were no statistically significant differences in cause-specific mortality, cancer, or other serious adverse events. And while the drug produced small increases in systolic and diastolic blood pressure, there was no statistically significant increase of serious adverse events attributed to hypertension.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome