Drugs

Novo Nordisk Sues Lilly Over GLP-1 Ads

Novo Nordisk has filed a Lanham Act suit in New Jersey federal court alleging that ads for Lilly’s GLP-1 drug Zepbound and Mounjaro (both tirzepatide) are deceptive because they reference outdated studies in an attempt to demonstrate the Lilly products are superior to Novo Nordisk’s Ozempic and Wegovy (both semaglutide).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 it had issued a formal cease-and-desist order that was not followed by Lilly, leading to the legal action.

The 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.”

It notes that FDA approved a higher dose of Wegovy in March that showed a 19% average weight loss, but that dose was not cited in the Lilly ads. It says there has been no head-to-head trial of the Lilly and Novo drugs at their highest doses.

Novo Nordisk is asking the court to issue a permanent injunction requiring Lilly to pull its “misleading” comparative advertising campaign across all platforms and to conduct a corrective ad campaign.

“As new and more effective treatment options become available,” says Novo Nordisk senior vice president and group general counsel John Kuckelman, “people deserve accurate information that reflects the latest scientific evidence and helps them make informed care decisions. Healthcare companies have a responsibility to keep their public claims accurate and current — ineffective, fine-print disclaimers do not fix the misleading impression created by major national campaigns.”

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