Expert Analysis

• Navigating A Key Inflection Point In Biosimilar Sector M&A

  

  As biosimilar mergers and acquisitions gain notice amid U.S. Food and Drug Administration reforms, a maturing patent framework and a looming patent cliff, companies diversifying into the higher-growth biologics space should align their regulatory, intellectual property and transactional strategies, say attorneys at Skadden.

• AI Meeting Recaps Pose New Discovery And Privilege Risks

  

  The New York City Bar Association’s recent ethics opinion, cautioning attorneys not to record nonclient conversations with artificial intelligence tools, reflects an emerging view that AI meeting recaps are now a distinct business record category, meaning counsel should set meeting-level controls and apply framework-level updates, says William Wright at Faegre Drinker.

• Class Actions At The Circuit Courts: September Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses six recent rulings involving pecuniary loss in false price comparison advertising, privity in an insurance fee class, antitrust standing, immigration class representatives, retirement beneficiary class commonality, and Rule 23(f) appeals in Fair Labor Standards Act claims.

• How Employers Can Navigate NLRB Rulings Ripe For Reversal

  

  Given a recent National Labor Relations Board memo seeking to reverse several precedents — including on severance agreements and workplace policies — employers should prepare now to restore broader protections when the board acts, while following the law as it exists today, says Howard Lavin at Thompson Coburn.

• What Comes Next For Digital Asset Regs After Clarity Act Flop

  

  After the U.S. Senate recently blocked the Digital Asset Market Clarity Act, agency rulemaking could still offer a near-term remedy, and companies meanwhile should monitor the existing framework assembled from enforcement precedent and case law in the absence of a purpose-built statute, say attorneys at Ropes & Gray.

• FDA Bill Shows Risk Of Inexact Statute Text, Post-Loper Bright

  

  A recent House bill to amend the Food and Drug Administration's drug preclusion framework reveals the increased importance of precision when drafting statutory rules in a post-Loper Bright landscape, as several minor errors in the text could lock in unintended results that will be difficult to repeal, say attorneys at Venable.

• Species 'Harm' Definition Rollback Brings Risk For Developers

  

  A rule recently adopted by federal agencies rescinds the definition of "harm" in Endangered Species Act regulations to exclude habitat destruction — but while the move is aimed at reducing regulatory burdens, it creates new uncertainty for developers, and may trigger increased environmental protections in California, say attorneys at Cox Castle.

• $95M Nev. Case Provides Clues On Wound Care Enforcement

  

  Federal prosecutors’ recent U.S. v. Dubin indictment, charging a Nevada physician with healthcare fraud over an alleged $95 million Medicare billing scheme involving amniotic wound allografts, provides a clearer picture of an increasingly data-driven enforcement strategy that follows the entire wound care transaction, say attorneys at Bass Berry.

• DOJ Fraud Memo Highlights Trade Enforcement Playbook

  

  A recent U.S. Department of Justice memo that outlines the Fraud Enforcement Division's priorities demonstrates that customs and trade fraud enforcement has entered a new and far more aggressive phase, with recent cases highlighting how the False Claims act is driving the new push, say attorneys at Foley & Lardner.

• HPE-Juniper Settlement Teaches Key Tunney Act Lessons

  

  A California federal court's recent approval of the U.S. Department of Justice's settlement with Hewlett Packard over its Juniper Networks acquisition offers legal practitioners some crucial lessons, including on unique tech-sector remedies for mergers and acquisitions and the continued viability of the Tunney Act, says Shubha Ghosh at Syracuse University College of Law.

• What Opt-In Framework Means For Novel Space Activities

  

  The U.S. Department of Commerce's Office of Space Commerce is advancing a voluntary certification framework for commercial space activities not covered by existing licenses — but it's unclear whether this approach becomes a durable mission authorization regime, and separate legal permissions from agencies may still be necessary, say attorneys at Morgan Lewis.

• Negotiating The Scope Of The Stablecoin Customer ID Rule

  

  Though comments on bank regulators’ proposed rule for stablecoin issuers under the Genius Act generally agree that oversight would help prevent illicit activity, agencies must reconcile disagreement over whether to extend customer identification requirements from issuers' primary-market relationships to secondary-markets activity, say attorneys at Ballard Spahr.

• How To Improve Hiring Transparency Amid Ghost Job Scrutiny

  

  Recent regulatory and state law scrutiny of ghost job postings for roles that don't exist or aren't being filled signals a shift toward hiring transparency, and employers that fail to adapt risk enforcement actions, consumer protection claims and financial penalties, say attorneys at Foley & Lardner.

• FTC Push May Create Dual Origin-Claim Risks For Contractors

  

  Recent Federal Trade Commission actions involving Made in USA advertising requirements offer a preview of enforcement themes that may impose dual compliance burdens on government contractors that are also subject to Federal Acquisition Regulation Buy American restrictions, says Amy Hoang at Seyfarth.

• Series

  Playing Bid Whist Makes Me A Better Lawyer

  

  As a child, I viewed bid whist as a family tradition and a source of friendly card game competition, but as a lawyer, I see it as a tool that has helped me cultivate skills like communication, teamwork, risk assessment and composure, says Keyonn Pope at Riley Safer.