Drugs

Bimagrumab Enhances Weight Loss: Study

New data from a Phase 2 study on Eli Lilly’s experimental bimagrumab showed that when combined with Novo Nordisk's Wegovy (semaglutide) it led to preservation of muscle mass while achieving significant weight loss. The data were presented 6/23 at an American Diabetes Association scientific session in Chicago.

The BELIEVE Phase 2b trial was a randomized, double-blind, placebo-controlled, multicenter study evaluating the effects of bimagrumab, alone and in combination with semaglutide, in overweight adults. The results showed that the combination led to greater reductions in weight, body fat, visceral fat, and markers of inflammation compared to either treatment alone. “The combination therapy yielded 92.8% of total weight loss from fat mass compared to semaglutide alone (71.8%) and a 22.1% decrease in bodyweight (−10.8% bimagrumab alone; −15.7% semaglutide alone),” according to a news release.

Bimagrumab is described as a first-in-class monoclonal antibody that targets activin Type II receptors, promoting muscle preservation and growth.

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