The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs. 

Ahead of Friday’s hearing on US Chamber of Commerce's suit against HHS, attorneys discuss potential remedies and carveouts to Inflation Reduction Act's drug price negotiation provisions, harms to industry that may support a preliminary injunction, and what would prompt Supreme Court review.

Private drug developer Fabre-Kramer is expecting approval for its antidepressant gepirone hydrochloride in September 2023. The drug has been rejected multiple times by the FDA as a treatment for major depressive disorder. 

In comments to regulators, manufacturers express concerns about the extensive R&D information being sought as part of the negotiation process. Pharmacy benefit managers also caution against reliance on R&D spending data for pricing decisions, but for a different reason.