North America: Food, Drugs, Healthcare, Life Sciences

On August 18, 2026, the U.S. Court of Appeals for the D.C. Circuit issued an important decision in Teva Pharmaceuticals USA, Inc. v. Kennedy, a challenge to the Centers for Medicare and Medicaid Services...

Le 29 juillet 2026, Santé Canada a annoncé avoir obtenu une injonction permanente contre une entreprise basée au Québec relativement à la vente de peptides injectables non autorisés au Canada.

The FDA has released new draft guidance establishing a comprehensive risk-based framework for evaluating container closure systems used in pharmaceutical packaging, marking a significant update from its 1999 guidance. This framework addresses five critical factors including material safety, environmental protection, performance standards, manufacturing impacts, and storage considerations, with particular emphasis on leachables assessment and quality control programs across different drug delivery routes.

The Federal Circuit vacated a PTAB decision on patent obviousness, establishing that a provisional application must provide written description support for at least one published claim to qualify as prior art under its earlier filing date. This ruling clarifies the requirements for claiming priority from provisional applications and impacts how patent practitioners should approach provisional filing strategies.

Biocon Limited has commercially launched YESAFILI (aflibercept-jbvf), a biosimilar to Regeneron's EYLEA, in the United States following settlement agreements that lifted previous injunction barriers. This marks the second aflibercept biosimilar available in the U.S. market, entering a competitive landscape where patent litigation continues to shape biosimilar entry strategies. The launch follows a complex legal journey involving multiple jurisdictions and settlement negotiations that ultimately permitted ea

On July 29, 2026, Health Canada announced that it had obtained a permanent injunction against a Québec-based company in connection with the sale of unauthorized injectable peptides in Canada. The announcement reflects Health Canada’s continued focus on peptide products and serves as a reminder that injectable peptides intended for human use are regulated as prescription drugs and are subject to Canada's drug regulatory framework.

On August 18, 2026, the U.S. Court of Appeals for the D.C. Circuit issued an important decision in Teva Pharmaceuticals USA, Inc. v. Kennedy, a challenge to the Centers for Medicare and Medicaid Services...

A new CMS rule bars federal Medicaid and CHIP funding for pediatric gender-affirming care, and legal experts are analyzing whether its notice-and-comment process will help it survive court challenges. The rule's reliance on a presidential executive order remains partially unsettled, with potential challenges to Medicaid-related provisions still possible.

Le 29 juillet 2026, Santé Canada a annoncé avoir obtenu une injonction permanente contre une entreprise basée au Québec relativement à la vente de peptides injectables non autorisés au Canada.