Drugs

Lilly’s Tirzepatide Meets Trial Weight Loss Endpoints

Lilly says its tirzepatide achieved superior weight loss compared to placebo in the 72-week Phase 3 SURMOUNT-1 study. A company statement says the drug met both co-primary endpoints of superior mean percent change in body weight from baseline and a greater percentage of participants achieving body weight reductions of at least 5% compared to placebo. It says the study also achieved all secondary endpoints at 72 weeks.

Participants taking tirzepatide lost up to 52 pounds in the study and 63% of participants taking the 15 mg dose achieved at least 20% bodyweight reduction as a key secondary endpoint, Lilly says.

Tirzepatide is described as “a once-weekly glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor agonist that integrates the actions of both incretins into a single novel molecule.”

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