Two of Japan's largest pharmaceutical companies, Tanabe Seiyaku and Taisho Pharmaceutical, are merging in response to hard times in the Japanese pharma industry. Their union, which will take at least a year to complete, will create a combined company with $4.3 billion in sales, ranking it third in Japan in revenues. The move won't solve both companies' weak pipeline problems, but it will increase their total R&D budget and give them more sales clout in the domestic market. And as many Japanese pharma companies struggle for survival, analysts believe more merger activity is inevitable.

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 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.