Drugs

Alcohol Use Disorder Drug Gets Fast Track

FDA has granted Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder. The company is currently evaluating pemvidutide in the Phase 2 RECLAIM trial. The primary endpoint is a reduction in the number of heavy drinking days, with secondary measures including improvements in World Health Organization risk drinking levels and biomarkers of alcohol consumption.

The company says pemvidutide has a dual mechanism of action — acting on both GLP-1 and glucagon receptors — that could reduce alcohol cravings while addressing liver fat and inflammation. In preclinical studies, the therapy produced a rapid and significant reduction in alcohol intake, it says.

Pemvidutide is also in development for metabolic dysfunction-associated steatohepatitis (MASH), alcohol-associated liver disease, and obesity, according to the company. In earlier trials, the drug demonstrated significant weight loss, improvements in liver fat and fibrosis, and favorable tolerability. A 48-week readout from the ongoing IMPACT Phase 2b MASH trial is expected in late 2025.

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