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…
Welcome to Part 5 of our 2026 Life Sciences Industry Outlook series. Today, we are wrapping up the week with a review of the regulatory environment for life sciences companies in 2025 and our expectations for what 2026 could bring. In 2025, life sciences companies faced a fast-moving regulatory environment shaped by the Trump administration’s…
Welcome to Part 4 of our 2026 Life Sciences Industry Outlook series. Today, we’re looking at life sciences collaborations and licensing activity in 2025 and what it may signal for 2026. 2025 life sciences licensing activity remained resilient and increasingly sophisticated, with stable deal volume, heightened structural customization, and growing geopolitical and technology-driven considerations shaping…
Welcome to Part 3 of our 2026 Life Sciences Industry Outlook series. Today, we are turning to royalty finance transactions in the life sciences industry in 2025 and what to expect in 2026. Once again, 2025 marked a year of meaningful growth for royalty finance, underscoring the continued evolution of royalty monetization transactions from niche…