Editor

Karen A. Spindler

Partner

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…

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: 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…

Introducing Our 2026 Life Sciences Industry Outlook Series

As the life sciences industry kicks off the new year and convenes at the JP Morgan Healthcare Conference this week, we are launching a weeklong Biotech Briefings series highlighting key insights from our 2026 Life Sciences Industry Outlook. Following a pivotal year in which deal activity accelerated and capital markets reopened selectively, the industry enters…