Takeda Adds Medicinal Chemistry Heft To NYC Research Partnership
This article was originally published in PharmAsia News
Joint research effort by three New York-based academic research organizations seeks to expedite translation of basic biomedical research into innovative therapies. Initial focus is on small molecules, but the plan is to branch out eventually into monoclonal antibodies and molecular imaging agents, as well.
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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.