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This article describes the current state-of-play with MFN and key deal drafting considerations. Life sciences dealmaking is running at a record pace — straight into a pricing regime that is still being written. According to Gibson Dunn’s July biopharma M&A survey, the first half of 2026 saw 13 announced acquisitions of public biopharma targets ranging…
On August 3, 2026, the California Supreme Court held in Gilead Tenofovir Cases (Aug. 3, 2026, S283862) ___ Cal.5th ___ (slip opn.), that a drug manufacturer owes no duty of care to users of a non-defective drug when deciding whether and when to commercialize an allegedly safer alternative drug. The Court reached that conclusion on…
Life sciences companies should be aware of a new contract clause and accompanying guidance from the Federal Acquisition Regulatory Council (“FAR Council”) implementing President Trump’s Executive Order 14398, Addressing DEI Discrimination by Federal Contractors. Effective April 24, 2026, all new Federal solicitations and contracts subject to the Federal Acquisition Regulation (“FAR”) must contain a new…
On February 18, 2026, FDA Commissioner Martin Makary and Vinay Prasad, then-Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research, published a landmark policy announcement in the New England Journal of Medicine that a single adequate and well-controlled pivotal trial — supplemented by confirmatory evidence — is now the…
In re BioAge Labs, Inc., Securities Litigation, No. 25-cv-00196, 2025 WL 3038991 (N.D. Cal. Oct. 30, 2025) Case Highlights In October 2025, a federal district court dismissed securities claims against a biopharmaceutical company, BioAge Labs, Inc., arising from disclosures in connection with its initial public offering (“IPO”) concerning the safety of the company’s lead drug…
What began as a series of demand letters in July 2025 has evolved into something significantly more consequential. By February 2026, sixteen of the seventeen largest pharmaceutical manufacturers have signed Most-Favored-Nation (MFN) pricing agreements with the Trump administration, which commit them to Medicaid price parity, MFN pricing on new product launches, and participation in TrumpRx.gov…