Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.
Iambic Therapeutics Inc.’s multiyear technology and discovery pact with Takeda Pharmaceutical Co. Ltd. could help the San Diego-based firm advance its own pipeline in a big way.
Iambic Therapeutics Inc.’s multiyear technology and discovery pact with Takeda Pharmaceutical Co. Ltd. could help the San Diego-based firm advance its own pipeline in a big way.
Amgen Inc. quit a development deal with Kyowa Kirin Co. Ltd., returning global rights for rocatinlimab, Kyowa Kirin’s T-cell rebalancing therapy being investigated for moderate to severe atopic dermatitis.
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
Amgen Inc. quit a development deal with Kyowa Kirin Co. Ltd., returning global rights for rocatinlimab, Kyowa Kirin’s T-cell rebalancing therapy being investigated for moderate to severe atopic dermatitis.
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
RSS
