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Latest From Immunomedics, Inc.
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.
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.
After immuno-oncology, mRNA is fast becoming a hot area in China as a flurry of biotechs from I-Mab to Kangtai partner with a little-known developer.
Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.
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