Worldwide: Food and Drugs Law

The landscape of pharmacy regulation in Ohio continues to evolve, and pharmacies licensed in the state should pay close attention to the Ohio State Board of Pharmacy’s latest proposed rulemaking. On July 1, 2026...

This month, the U.S. Food & Drug Administration (“FDA”) quietly published its Unified Agenda, which includes a proposed rulemaking that — if finalized — would fundamentally reshape the landscape...

The Federal Trade Commission's landmark settlement with Caremark fundamentally restructures how one of America's three largest prescription drug benefit managers operates, targeting allegedly anticompetitive practices that artificially inflated medication costs. The agreement mandates sweeping reforms to formulary design, rebate strategies, and fee structures that the FTC claims have cost patients billions while enriching PBMs as pharmaceutical supply chain gatekeepers.

Teva Pharmaceuticals and Polpharma Biologics have entered into a global licensing agreement for the commercialization of a biosimilar candidate to Genentech's OCREVUS (ocrelizumab), a treatment for multiple sclerosis. The agreement combines Polpharma Biologics' development expertise with Teva's commercial capabilities across major markets including the United States, Europe, and several other territories. Under the terms, Polpharma Biologics will handle development and manufacturing while Teva manages regul

The first half of 2026 brought significant M&A activity and regulatory developments in life sciences, with the FTC returning to traditional antitrust enforcement principles. While this shift has added predictability to the regulatory landscape, practitioners must remain vigilant as agencies continue to scrutinize problematic transactions, particularly those involving emerging therapeutic areas or novel competitive dynamics.

This comprehensive update examines major antitrust enforcement actions and regulatory developments across seven jurisdictions during mid-2026, including landmark U.S. litigation over pharmaceutical pricing, DOJ investigations into agricultural markets and healthcare contracting, and significant European Commission proceedings involving vaccine disparagement and foreign subsidies. The report also covers enforcement activities by competition authorities in Mexico, Poland, Italy, the Netherlands, and Germany's

On July 7, the Centers for Medicare & Medicaid Services (CMS) published a proposal to cut Medicare Part B payment rates to certain hospitals in the 340B drug pricing program for separately payable drugs purchased...

Vertex Pharmaceuticals has secured FDA approval to expand CASGEVY's indication to children as young as two years old with sickle cell disease or transfusion-dependent beta thalassemia, making it the first CRISPR-based gene-editing therapy available for this younger patient population. The approval, reviewed under the FDA's Commissioner's National Priority Voucher pilot program, follows recent European data presentations demonstrating efficacy and safety in pediatric patients. This expansion allows clinician

The FDA has proposed a major regulatory shift that would eliminate the "adequate provision" option for broadcast prescription drug advertisements, potentially requiring pharmaceutical companies to include full risk disclosures in every TV and radio ad.