The More Things Change: Gene Therapy Reopens Orphan Drug 'Sameness' Debate
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Orphan Exclusivity For Gene Therapies Hinges On Two Big Factors
US FDA draft guidance says that ‘minor differences’ in transgenes and/or vectors won’t be enough for orphan exclusivity, but agency will consider ‘additional features of the final product’ in making the determination.
Medicare Reaffirms Faith In Formulary Review Process Ahead Of Part D Changes
Dramatic transformation in the US Medicare Part D benefit design does not require any changes to CMS’ overall approach to reviewing formulary submissions from private drug plan sponsors, the agency says in its final guidance implementing the design changes for 2025.
Cost-Based Pricing: The Real Threat Hiding In Latest US Drug Price Headlines
Bernie Sanders is back at it, getting headlines for demanding immediate price cuts to Novo’s blockbuster GLP-1 brands. But behind the familiar rhetoric is a newer threat: academic research on cost-based pricing that could one day feed into the emerging Medicare ‘negotiation’ system.