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The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar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.

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.

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.

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.

Series

Playing Piano Makes Me A Better Lawyer

Playing piano and practicing law share many parallels relating to managing complexity: Just as hearing an entire musical passage in my head allows me to reliably deliver the message, thinking about the audience's impression helps me create a legal narrative that keeps the reader engaged, says Michael Shepherd at Fish & Richardson.

3 Cases Highlight SEC Distinction Between Exec, Co. Liability

Three recent enforcement actions against Spero Therapeutics, Lottery.com and Archer-Daniels-Midland demonstrate that while public companies are subject to liability for misrepresentations, the U.S. Securities and Exchange Commission is focused on individual liability when disclosure violations involve so-called half-truths, say attorneys at Cooley.

AI-Generated Doc Ruling Guides Attys On Privilege Risks

A New York federal court's ruling, in U.S. v. Heppner, that documents created by a defendant using an artificial intelligence tool were not privileged, can serve as a guide to attorneys for retaining attorney-client or work-product privilege over client documents created with AI, say attorneys at Sher Tremonte.

The Law Firm Merger Diaries: Leadership Strategy After Day 1

For law firm leaders, ensuring a newly combined law firm lives up to its promise, both in its first days of operation and well after, includes tough decisions, clear and specific communication, and cheerleading, says Peter Michaud at Ballard Spahr.

Record FCA Recoveries Signal Intensified Healthcare Focus

In its recently released False Claims Act statistics, the U.S. government's emphasis on record healthcare recoveries and government-initiated healthcare matters last year indicates robust enforcement ahead, though the administration's focus on current policy objectives also extends beyond the healthcare sector, say attorneys at Epstein Becker.

Fed. Circ. In Jan.: On The Validity Of Expert Testimony

The Federal Circuit's recent decision in Barry v. DePuy, addressing whether expert testimony is admissible even if it does not strictly adhere to the court's claim construction, suggests that exclusion via a Daubert motion is appropriate only when the line to improper testimony is clearly crossed, say attorneys at Knobbe Martens.

Calif.'s Civility Push Shows Why Professionalism Is Vital

The California Bar’s campaign against discourteous behavior by attorneys, including a newly required annual civility oath, reflects a growing concern among states that professionalism in law needs shoring up — and recognizes that maintaining composure even when stressed is key to both succeeding professionally and maintaining faith in the legal system, says Lucy Wang at Hinshaw.

A Potential Shift In FDA's Approach To Drug Trial Design

Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combine prior knowledge with new data — may be used in clinical trials reflects the agency's continued interest in innovative trial designs that may accelerate drug approvals, say attorneys at Alston & Bird.

Series

Trivia Competition Makes Me A Better Lawyer

Playing trivia taught me to quickly absorb information and recognize when I've learned what I'm expected to know, training me in the crucial skills needed to be a good attorney, and reminding me to be gracious in defeat, says Jonah Knobler at Patterson Belknap.

What FDA Guidance Means For Future Of Health Software

Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.