Amgen’s Rebate Bundling Makes It ‘Economically Unfeasible’ For Regeneron To Sell Praluent

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.