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 FDA’s default standard for approving novel drugs.[1] The agency’s longstanding practice of requiring two pivotal trials has not been a statutory mandate since 1997: at that time, Congress amended the Federal Food, Drug, and Cosmetic Act to provide that data from one adequate and well-controlled trial and confirmatory evidence can constitute ‘substantial evidence’ of effectiveness.[2] In some therapeutic areas, such as in oncology and rare disease, FDA increasingly has approved drugs on the basis of a single clinical trial, but, as a matter of general agency policy, two trials have been the baseline norm for decades.[3] That norm has now changed.
License Agreements
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 in exchange for three-year tariff immunity and improved regulatory positioning. But as those voluntary deals settle, the Centers for Medicare & Medicaid Services (CMS) has moved to make MFN pricing mandatory for Medicare through two new models: GLOBE (Medicare Part B) and GUARD (Medicare Part D), both published in the Federal Register on December 23, 2025, with a public comment period that closed on February 23, 2026.
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 how biotechs and large pharmaceutical companies approach partnerships heading into 2026.
Potential Impacts of Most-Favored-Nation Executive Order on Ex-US License Agreements
Introduction
On May 12, 2025, President Donald Trump signed an Executive Order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients”. This order aims to address the perceived imbalance where the United States funds a significant portion of global pharmaceutical profits and pays high prices, while drug manufacturers offer deep discounts to access foreign markets, subsidizing those lower prices through higher prices in the United States. The stated purpose of the Executive Order is to ensure that Americans are not forced to pay almost three times more for the same medicines and have access to the most-favored-nation (MFN) price.