MundiPharma Survey Finds 23 Million Japanese Suffer From Chronic Pain
This article was originally published in PharmAsia News
Executive SummaryNearly one in four Japanese adults ( roughly 23.15 million) suffer from chronic pain, according to a survey conducted by MundiPharma
You may also be interested in...
US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca choose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.
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.