Drugs

Icosapent Ethyl Cuts Ichemic Events: Study

A study (REDUCE-IT) funded by Amarin Pharma shows that among patients with elevated triglyceride levels despite use of statins, the risk of ischemic events, including cardiovascular death, is significantly lower among those receiving 2 g of icosapent ethyl twice daily than among those receiving placebo. Researchers from Harvard Medical School and other centers around the world reported the findings in the New England Journal of Medicine.

The researchers write that icosapent ethyl is a highly purified and stable EPA (eicosapentaenoic acid) ethyl ester that has been shown to lower triglyceride levels and may have anti-inflammatory, antioxidative, plaque-stabilizing, and membrane-stabilizing properties.

In the study, the overall rates of adverse events were similar in the trial groups, the report says.

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