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.
Government Regulation
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: 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 priorities, including deregulation, the use of policy levers to encourage domestic manufacturing and development, and efforts to reduce healthcare costs for American consumers. We expect this unpredictable atmosphere to continue into 2026. In particular, we anticipate regulatory and enforcement developments in FDA regulation, drug pricing and reimbursement, government contracts, tariffs, and antitrust oversight, although specific outcomes and impacts remain difficult to predict.
Getting Ready for Your Q3 Quarterly Reports: Updated Disclosure Regarding Tariffs and Government Shutdown
As public companies prepare their third quarter Form 10-Q filings, the rapidly shifting policy landscape has created new disclosure challenges for the life sciences sector. The recently announced pharmaceutical tariffs and ongoing government shutdown both carry potential financial and operational implications that warrant close attention. For biotech companies, these developments underscore the need for clear, proactive disclosure around supply chain resilience, pricing exposure, and regulatory uncertainty. In this post, we outline key disclosure considerations to help issuers navigate this evolving environment and manage investor expectations heading into the end of the year.
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.
Trump’s 100% Pharma Tariffs: Manageable for Large Pharma; Challenging for Biotechs
On September 25, 2025, President Trump announced 100% tariffs on imported branded or patented pharmaceuticals, effective October 1, 2025, unless the importing company is building U.S. manufacturing capacity (defined in President Trump’s announcement as “breaking ground and/or under construction”). The policy is being advanced under Section 232 “national security” authority.
What Life Sciences Companies Should Know About the New Trade Fraud Task Force
On August 29, 2025, the Department of Justice (DOJ) launched the Trade Fraud Task Force that will coordinate efforts between DOJ’s Civil and Criminal Divisions and the Department of Homeland Security (DHS) to bring enforcement actions against importers who unlawfully evade tariffs and other customs duties, as well as against parties who unlawfully import prohibited goods.[1] This is the latest sign that, amid legal battles over the legality of President Trump’s tariffs, DOJ remains deeply committed to using all available legal tools to police customs and tariff compliance. It is also the latest example of this Administration’s top-down approach to generating investigative targets.
Expanded QSBS Benefits: What Biotech Founders Need to Know After the “One Big Beautiful Bill” Act
Why this matters for biotech start-ups
Raising capital for drug discovery often pushes early-stage biotech companies above the gross asset limit for qualifying for the U.S. federal income tax benefits associated with qualified small business stock (“QSBS”). The law commonly referred to as the One Big Beautiful Bill Act (the “OBBBA”), signed into law on July 4, 2025, lets founders and other investors greater access these tax savings—potentially reducing their tax bill by millions when the company is sold.
Getting Ready for Your Q2 Quarterly Reports: Trends in Biopharmaceutical Disclosures from Q1 Quarterly Reports
Earlier this year, the new Presidential Administration introduced a series of policies, legislative proposals and regulatory actions that have impacted the business and regulatory environment and contributed to a climate of uncertainty—particularly in the biopharmaceutical sector. These developments gave companies much to address in their first quarter 10-Q filings. To shed light on how biopharmaceutical companies addressed these developments, we conducted a survey of the Q1 Quarterly Reports of the top 100 biopharmaceutical companies. Our analysis revealed that most companies are actively assessing the potential impact of these changes, with more than two-thirds (68%) of companies updating their risk factors and more than half (53%) updating their Management’s Discussion & Analysis (MD&A) accordingly. Below is a summary of the key disclosure changes, with a focus on topics of heightened relevance to the industry—including tariffs, changes in laws related to Medicaid or Medicare, federal workforce disruptions and other issues such as the Section 232 investigation and the Section 340B Drug Pricing Program.
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.