Biotech Briefings

One and Done: FDA’s New Single-Trial Default and What It Means for Drug Developers, Investors, and Counsel

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…

When Should Companies Disclose Drug Safety Risks?

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…

MFN Drug Pricing in 2026: Voluntary Deals Are Giving Way to Mandatory Rules — Five Things Life Sciences Companies Need to Know

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…

2026 Life Sciences Industry Outlook: Regulatory Environment

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…

2026 Life Sciences Industry Outlook: Collaborations and Licensing

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…

2026 Life Sciences Industry Outlook: Royalty Finance

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…