United States: Food, Drugs, Healthcare, Life Sciences

On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi)...

The EU's manufacturing waiver for supplementary protection certificates (SPCs) permits third parties to manufacture medicinal products for export outside the EU, but divergent court interpretations have led to a 2026 CJEU referral. As national courts grapple with notification requirements and stockpiling provisions, the European Commission has announced a public consultation to evaluate whether the waiver has achieved its intended objectives.

The Inflation Reduction Act, signed into law in August 2022, enacted significant changes in the way the government treats certain prescription drugs under the Medicare program.

On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi)...

CVR usage surged from 7 publicly disclosed deals in 2024 to 27 deals in 2025, with some CVRs representing over 70% of total deal value.

The written description and enablement analyses are context-dependent; claim type may affect the written description and enablement analyses.

On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi)...

The legal challenge recently filed by Express Scripts against Tennessee’s Fair Rx Act is about far more than a single state law. At its core, the lawsuit is a fight over whether states have the authority to address...

On June 12, 2026, the Centers for Medicare and Medicaid Services (CMS) issued Proposed Rule CMS-4215-P, which would establish a permanent regulatory framework for the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act (IRA).