FDA's Biosimilarity Guidance Holds Uncertain Implications

The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar competition, and could affect biosimilar access in unexpected ways, say analysts at Analysis Group.

Unpacking Key Themes From NY's New Healthcare Strategy

New York Gov. Kathy Hochul's 2026 State of the State agenda, read together with the state's fiscal year 2027 executive budget, reflect a clear framework to utilize Medicaid as the state's operating platform for healthcare reform, say attorneys at Sheppard.

A Single DOJ Corporate Enforcement Policy Raises Questions

The U.S. Department of Justice's soon-to-be-released uniform corporate criminal enforcement policy could address the challenges raised by the current decentralized approach, but it will need to answer a number of potential questions amid scant details, say attorneys at Pillsbury.

WTO Most‑Favored‑Nation Reform May Hold Promise

When the World Trade Organization meets later this month, it is expected to debate changing the most-favored-nation rule, a carefully calibrated loosening of which may be justified if it enables deeper liberalization and regulatory cooperation, says Alan Yanovich at Akin.

Navigating Exclusion Decisions After SEC's No-Action Change

Following the U.S. Securities and Exchange Commission's November changes to the Rule 14a-8 no-action letter process, shareholder proponents have turned to litigation if companies excluded their proposals under the new framework, with three recent cases offering useful lessons for companies navigating exclusion decisions this proxy season, say attorneys at Cleary.

5 Different AI Systems Raise Distinct Privilege Issues

A New York federal court’s recent U.S. v. Heppner decision, holding that a defendant’s use of Claude was not privileged, only addressed one narrow artificial intelligence system, but lawyers must recognize that the spectrum of AI tools raises different confidentiality and privilege questions, says Heidi Nadel at HP.

Fed's Abbreviated Supervisory Statement Packs A Big Punch

Language used in a recent three-page statement from the Federal Reserve Board charts a very clear shift in the supervision of banks and bank holding companies, departing from traditional "Fed speak" and emphasizing material financial risks in exams, says Joseph Silvia at Duane Morris.

After Learning Resources: A Practical Guide For US Importers

Following the U.S. Supreme Court's Feb. 20 decision in Learning Resources v. Trump, U.S. importers and consumers on whom tariffs were imposed under the International Emergency Economic Powers Act can seek relief through existing administrative procedures or a yet-to-be-determined bespoke refund mechanism, and should plan for more changes in the tariff landscape, say attorneys at Baker Botts.

State, Federal Policies Complicate Fuel And Carbon Markets

As federal and state regulators advance a complex web of mandatory and voluntary programs and incentives that shape how transportation fuels are produced, traded and valued, new compliance obligations present both risks and opportunities for fuel market and carbon market participants alike, says Sarah Grey at Arnold & Porter.

Opinion

AI-Assisted Arbitration Needs Safeguards To Ensure Fairness

As tribunals and arbitral institutions increasingly use artificial intelligence tools in their decision-making processes, ​​​​​​​clear disclosure standards and procedural safeguards are necessary to ensure that efficiency gains do not erode the fairness principles on which arbitration depends, says Alexander Lima at Wesco International.

Paramount-WBD Deal Would Widen Net For Antitrust Scrutiny

The fresh likelihood of a merger between Paramount and Warner Bros. Discovery raises the prospect of added intervention from the U.S. Department of Justice due to the companies' overlaps in key markets, and may signal expanded DOJ scrutiny of potential anticompetitive effects on supply chains, says Shubha Ghosh at the Syracuse University College of Law.

Logistics Update: What Immigrant Driver Rule Means For Cos.

The Federal Motor Carrier Safety Administration's new final rule restricting issuance of commerical driver's licenses for nondomiciled drivers will have immediate operational implications for motor carriers, but the broader effects will ripple through relationships between service providers and their sources of freight, including brokers and shippers, say attorneys at Benesch.

Trans Care Enforcement Landscape Is Evolving Quickly

The recent coordinated federal effort to reshape pediatric gender-affirming care through enforcement and funding pressure has created a rapidly evolving regulatory environment marked by shifting risk assessments and potential downstream market effects for healthcare institutions and life sciences companies, say attorneys at Arnall Golden.

How Del. High Court's Moelis Reversal Fits Into DExit Debate

By declining to decide the facial validity of the provisions at issue in Moelis & Co. v. West Palm Beach Firefighters Pension Fund, the Delaware Supreme Court's recent reversal of the Court of Chancery's 2024 ruling highlights broader implications for the ongoing debate over whether companies should incorporate elsewhere, say attorneys at Akin.

Planning For M&A Complexity After New State 'Mini-HSR' Laws

After the recent enactment of California's mini-HSR law, and with Indiana poised to pass its own, requiring the submission of Hart-Scott-Rodino premerger notifications to state attorneys general, practitioners should expand their deal planning to include state-by-state reportability as more states adopt similar mandatory merger-notification requirements, say attorneys at McDermott.