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.
M&A
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: Mergers and Acquisitions
Welcome to Part 1 of our 2026 Life Sciences Industry Outlook series. We are kicking off the week with a look at life sciences M&A activity in 2025 and what it may signal for 2026.
M&A activity in 2025 accelerated sharply, marking one of the busiest years on record. Aggregate deal value and the number of announced transactions rose meaningfully from 2024, buoyed by marginally improving financing conditions, greater boardroom confidence, and clearer regulatory expectations in the second half of the year. Mega-cap and upper‑mid‑market deals returned alongside a still‑healthy cadence of bolt‑on acquisitions and other smaller transactions by companies focused on incremental pipeline enhancements and portfolio gaps. Therapeutically, 2025 activity remained anchored beyond traditional oncology into cardio-metabolic (including obesity-adjacent assets) and neuroscience/CNS, while radiopharmaceuticals continued to command strategic interest and autoimmune/immunology remained a steady source of durable, de-risked, later-stage pipeline reinforcements.
M&A Thirty Days into the Government Shutdown: First Transaction to Close That Launched During the Shutdown
Thirty days into the U.S. government shutdown, most federal agencies are operating with only “essential” personnel. The SEC and FTC are running with minimal staffing, authorized to take only limited actions. At the SEC, no registration statements have been declared effective since the shutdown began, and a backlog of more than 1,000 filings is expected to await review once operations resume.
The Current Landscape of Reverse Mergers: An In-Depth Analysis and Q&A
Branden Berns and Ryan Murr are the authors of “The Current Landscape of Reverse Mergers: An In-Depth Analysis and Q&A” [PDF] published by DealLawyers.com on April 2, 2025.
Webcast: M&A Insights: Earn-Outs, New HSR and Investment Rules, and Fraud Liability
Join us for a 45-minute briefing covering several M&A practice topics. The program is part of a series of quarterly webcasts designed to provide quick insights into emerging issues and practical advice on how to manage common M&A problems. Steve Glover, a partner in the firm’s Global M&A Practice Group, acts as moderator.
Federal Circuit Decision in Allergan v. MSN
On August 13, 2024, the Federal Circuit issued a precedential decision on the issue of obviousness-type double patenting (ODP) and patent-term adjustment (PTA) in Allergan USA, Inc. et al., v. MSN Laboratories Private Ltd., et al., No. 24-1061 (Fed. Cir. Aug. 13, 2024). While the decision also addressed other issues, this update focuses on summarizing the Court’s holding on the ODP issue.
Delaware Court of Chancery Opines on Meaning of ‘Commercially Reasonable Efforts’ in Pharmaceutical Earn-Out Provision
Ryan Murr, Karen Spindler, Todd Trattner, Marina Szteinbok and Artin Au-Yeung are the authors of “Delaware Court of Chancery Opines on Meaning of ‘Commercially Reasonable Efforts’ in Pharmaceutical Earn-Out Provision” [PDF] published by the Deal Lawyers in its May-June 2024 issue.
Delaware Court of Chancery Opines on the Meaning of “Commercially Reasonable Efforts” in a Pharmaceutical Earn-Out Provision
Observations and drafting suggestions for CRE terms in merger agreements, licenses, and royalty purchase agreements.
On April 30, 2024, the Delaware Court of Chancery held that the buyer in a life sciences merger and its successor had not breached their contractual obligations under an earn-out provision to use commercially reasonable efforts (“CRE”) to achieve regulatory approvals for a pharmaceutical product. In Himawan, et al. v. Cephalon, Inc., et al., Vice Chancellor Glasscock found that the merger agreement’s definition of CRE for purposes of the earn-out provision, which referred to the efforts of a company with substantially the same resources and expertise as the buyer, required the Court to analyze whether a reasonable actor faced with the circumstances would continue to pursue the development of a drug that had failed to meet one of its co-primary endpoints in an earlier clinical trial.[1]
Behind The ‘CVR Spin’ Method Of Unlocking Assets In M&A
San Francisco partner Ryan Murr, Washington, D.C. partner Stephen Glover and San Francisco partner Branden Berns are the authors of “Behind The ‘CVR Spin’ Method Of Unlocking Assets In M&A” [PDF] published by Law360 on March 11, 2024.