United States: Food, Drugs, Healthcare, Life Sciences

On Thursday September 25, the U.S. Department of Justice (DOJ) announced the creation of a new Enforcement & Affirmative Litigation Branch within the Civil Division.

Clinical translation isn't just words; it's a strategy. Mistakes can delay approvals, trigger FDA queries, or even compromise your clinical data credibility.

In an opinion published on September 22, 2025, the Second Circuit affirmed the convictions of Dr. Seth Fishman and Lisa Giannelli for their roles in two conspiracies to manufacture and distribute adulterated and misbranded...

On September 30, 2025, the U.S. District Court for the Northern District of California ordered Biogen MA, Inc.

The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. ("Regeneron") filing suit under the Biologics...

Volatile equity markets and costly debt are fueling interest in monetization transactions. Data, recent deals, and increasing interest suggest the model is set to endure.

In our latest What's Your Moonshot? episode, A&M Healthcare Industry Group's David Shulkin, M.D. and Bionca Jones were joined by Heather Farley, M.D., MHCDS, former inaugural Chief Well-being Officer...

Two new laws, the Civilian Reservist Emergency Workforce ("CREW") Act and the Senator Dole 21st Century Veterans Healthcare and Benefits Improvement Act ("Dole Act") expand the workplace regulations that employers must follow under the Uniformed Services Employment and Reemployment Rights Act ("USERRA").

Welcome to Wiley's update on recent developments and what's next in consumer protection at the Federal Trade Commission (FTC), Consumer Financial Protection Bureau (CFPB), and the state level.

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101.

GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech's Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents.