Gates Foundation, 13 Biopharmas Will Work To Eradicate Or Control Neglected Tropical Diseases By 2020
This article was originally published in The Pink Sheet Daily
The effort, led by WHO, the World Bank and governmental agencies, will focus on donating drugs for 10 neglected tropical diseases, as well as a research collaboration to come up with new therapies.
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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.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.