FTC Wins $448M Ruling Against AbbVie For Sham Litigation Rather Than Pay-For-Delay Deal

Court finds AbbVie used sham litigation to maintain its monopoly on AndroGel but denies FTC request for an injunction; it is the largest monetary award in a litigated FTC antitrust case.

Man Controlling Trade statue in front of the Federal Trade Commission Building

While the Federal Trade Commission lost out on claims AbbVie Inc. engaged in a pay-for-delay deal, it won the overall battle with a court ruling that the company filed sham infringement suits against Teva Pharmaceuticals USA Inc. and Perrigo Co. PLC to block generic competition for its transdermal testosterone replacement therapy AndroGel.

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Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In Lawsuit

 
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Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.

Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 

Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

HHS Wants 340B Rebate Debate Out Of Courts, Returned To Government

 
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An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach’ in weighing the possibility. Past experience suggests otherwise, a pricing expert said.

More from Pink Sheet

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
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Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA