Drug Fix: CMS Listens On Price Negotiations, Elevidys Top-Line Trial Data, Gene Therapy Reg Changes

Pink Sheet reporters and editor discuss take-aways from the first Medicare price negotiation program public listening sessions (:35), next steps after Sarepta reported questionable top-line data for its Duchenne muscular dystrophy gene therapy Elevidys (14:45), and indications the FDA may adjust its regulatory approach to gene editing products (26:27). More On These Topics From The Pink Sheet Could Government Negotiated Prices Curtail Access? PBMs And Potential Perverse Incentives Dominate First Medicare Listening Session: https://pink.citeline.com/PS149097/Could-Government-Negotiated-Prices-Curtail-Access-PBMs-And-Potential-Perverse-Incentives-Dominate-First-Medicare-Listening-Session Elevidys And The EMBARK Trial: Is Another Advisory Committee Meeting Coming? https://pink.citeline.com/PS149282/Elevidys-And-The-EMBARK-Trial-Is-Another-Advisory-Committee-Meeting-Coming US FDA’s Confidence In Gene Editing Safety Growing Enough That Regulatory Bar May Be Lowered: https://pink.citeline.com/PS149289/US-FDAs-Confidence-In-Gene-Editing-Safety-Growing-Enough-That-Regulatory-Bar-May-Be-Lowered Heritable Genetic Modification Debate May Ignite Again As Technology Advances: https://pink.citeline.com/PS149098/Heritable-Genetic-Modification-Debate-May-Ignite-Again-As-Technology-Advances