The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…
REGULATORY
US, European Trade Groups Oppose Tighter Re-Pricing Rules
US and European pharma industry associations said on December 6 that they are fully aligned with their Japanese counterparts in their requests towards Japan's next drug pricing reform in April, expressing their positions against the proposed tightening of re-pricing rules…
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