Drugs

Novo Nordisk Seeks Preliminary Injunction Against Lilly

Novo Nordisk has filed a motion for a preliminary injunction in the New Jersey District Court, seeking to stop Eli Lilly's “misleading” GLP-1 advertising campaigns while an earlier Novo Nordisk lawsuit proceeds.

The move follows Novo Nordisk's lawsuit last week (see story) alleging that ads for Lilly’s Zepbound and Mounjaro (both tirzepatide) are deceptive because they reference outdated studies in an attempt to demonstrate the Lilly products are superior to Novo Nordisk’s Ozempic and Wegovy (both semaglutide). A Novo Nordisk statement says the Lilly ads intentionally compare Lilly’s highest doses against lower doses of Novo Nordisk’s drugs, “deceptively presenting these results as proof of broad, product-level superiority while burying or omitting critical clinical context.”

Novo Nordisk says that since filing the lawsuit, Lilly failed to remove the “confusing and deceiving” direct-to-consumer campaigns. “We welcome competition grounded in honest, up-to-date science, but we cannot stand by as advertising continues to withhold the information patients need and deserve when making decisions about their health," Novo Nordisk group general counsel John F. Kuckelman is quoted in a release as saying. “Millions of Americans living with obesity and Type 2 diabetes rely on these medicines. Misleading advertisements that selectively compare lower doses of Novo Nordisk's medicines against higher doses of Lilly’s medicines, based on outdated studies, leave patients with the mistaken impression that Lilly's drugs are vastly superior, and that is simply not true.”

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