Drugs

Compounder Says Lilly, Novo Nordisk Violate Antitrust

Strive Specialties, a compounding pharmacy headquartered in Arizona with offices, staff, and customers in Texas, has filed a lawsuit in a Texas federal court, charging that Eli Lilly and Novo Nordisk are violating antitrust laws in their marketing of glucagon-like peptide 1 agonist (GLP-1) drugs, which are indicated for weight loss. Strive says it competes by compounding personalized GLP-1 drugs at lower prices, and says Lilly and Novo Nordisk’s actions have restricted competition and harmed patient access to affordable medications.

Competition between the innovator companies and compounding pharmacies led to the innovators creating online pharmacies that sell GLP-1 drugs at reduced prices, Strive says, but don’t address the clinical needs of patients who need personalized versions of the drugs. It also claims the two companies entered into exclusive agreements with telehealth providers that barred them from working with compounding pharmacies.

According to the complaint, Lilly disparaged compounded drugs by saying they were “always illegal,” and sought to interfere with Strive’s relationship with third-party technology platforms and payment processors.

“Eli Lilly and Novo Nordisk’s conduct is illegal under the United States’ antitrust laws,” Strive says. “It is meant to preserve their supracompetitive prices by forestalling all competition, no matter how small…. As a result, patients are forced to pay inflated prices and suffer reduced access to GLP-1 medicines, particularly personalized versions of those medicines. Strive seeks to restore competition to the world of GLP-1 medicines, allowing patients to benefit from improved access and lower costs.”

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