Eli Lilly and Co. lost its bid to have the U.S. Supreme Court strike down the whistleblower provisions in the False Claims Act (FCA) as unconstitutional.
It looks like the end of the road for many of the court challenges to the Inflation Reduction Act’s (IRA) provision requiring Medicare to negotiate prescription drug prices. The U.S. Supreme Court denied cert May 18 to petitions brought by six biopharma companies that raised questions about the constitutionality of the negotiations. All but one of the suits involved were denied in the Third Circuit; the other one was denied in the Second Circuit, so there is no circuit split – yet.
Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.
