Biotech Briefings

False Claims Act 2026 Mid-Year Update

This update summarizes noteworthy enforcement activity from the first six months of 2026. We discuss significant federal policy and state legislative developments, including the current status of state false claims statutes. We also analyze the most consequential court decisions of the first half of the year.

New DEI Compliance Requirements for Federal Contractors – What Life Sciences Companies Need to Know

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…

Recent China Actions Elevate Conflicts of Law Risks for Global Companies; Trump-Xi Summit Signals Hope for “Détente” in Some Areas

Despite recent high-level U.S.-China talks, several recent developments in China have elevated international trade-related compliance risks and challenges for companies with commercial ties to mainland China or dealings with Chinese counterparties.  While it is unclear the extent to which these developments move the needle in terms of practical legal and enforcement implications in China, there…

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…