International Horizon Scanning Initiative To Level Pricing Playing Field
Transparency In Data Is A Key Concern
Nine countries are joining forces on horizon scanning with the aim of improving their chances of securing lower prices for high-cost drugs.
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Francis Arickx from the cross-country coalition BeNeLuxA spoke this month about how the initiative had delivered proof of concept and discussed why uniting across borders is important for delivering access to transformative but expensive medicines.
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.