BioMarin Pharmaceutical Inc.
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Latest From BioMarin Pharmaceutical Inc.
Adverum said it would cease developing ADVM-022 for DME and focus on wet AMD, but the adverse events that prompted the shift could invite further scrutiny in an already competitive market.
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.
Japan’s Meiji Seika Pharma and Korea’s Dong-A have struck an exclusive licensing deal with Intas for global rights to the pair’s DMB-3115 proposed ustekinumab biosimilar to Stelara.
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