Food, Drugs, Healthcare, Life Sciences

On June 11, 2025, Assistant Attorney General Brett Shumate issued a memorandum to all U.S. Department of Justice (DOJ) Civil Division employees outlining enforcement priorities under directives...

In its June 2025 meeting, the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinions for six biosimilar medicines.

The Inflation Reduction Act (IRA) fundamentally changed the economics of the Part D marketplace.

The National Security Commission on Emerging Biotechnology (NSCEB) announced on July 1, 2025, that it is gathering input to modernize U.S. biotechnology product regulation and create simpler...

On June 18, 2025, the U.S. Supreme Court delivered a major decision in United States v. Skrmetti, allowing Tennessee's ban on gender-affirming care for minors to take effect.

On June 20, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-04, in which it declined to approve a proposal by a medical...

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.

Dr. George Bonanno, professor of psychology at Columbia University and head of the Loss, Trauma, and Emotion Lab, joins us to challenge everything you think you know about trauma and resilience.

On June 11, 2025, Assistant Attorney General Brett Shumate issued a memorandum to all U.S. Department of Justice (DOJ) Civil Division employees outlining enforcement priorities under directives...

Effective January 1, 2026, the Texas Responsible Artificial Intelligence Governance Act (TX H.B. 149, 2025) takes a unique approach to AI regulation—pulling threads from the EU AI Act...