Drugs

Boehringer Reports Gains on Liver Disease Candidate

Boehringer Ingelheim says data from its recent Phase 2 survodutide study showed that up to 83.0% of adults treated with the drug achieved a statistically significant improvement of the chronic liver disease metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%). “The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring),” the company says. The drug also met all secondary endpoints, including a statistically significant improvement in liver fibrosis, it adds.

Survodutide is described as a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action. “The glucagon agonist component in survodutide has the potential to increase energy expenditure, and has a direct impact in the liver which potentially contributes to the improvement of fibrosis,” Boehringer says, adding that the GLP-1 agonist component curbs the appetite “while increasing fullness and satiety.”

Additionally, Boehringer notes survodutide is being evaluated in five Phase 3 studies for overweight people and those living with obesity, among key sub-populations.

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