Keeping Track: US FDA Approvals Include Novel Agents Zepzelca And Uplizna, Biosimilar Nyvepria, Follow-On Semglee
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Plus deals involving Zai Lab/Karuna, Zai Lab/Blueprint, Lotus/PharmaMar, Nippon Shinyaku/Dynacure, Alphamab/Ascletis, Aptose/Hanmi, Shanghai Pharmaceuticals/HUYABIO, KoBioLabs/SPH Sine, CURACLE/ Théa Open Innovation, Signet/XtalPi, Curi Bio/NEXEL, CANbridge/Scriptr and Ligand/CRDC.
US FDA’s John Concato cites rigorous collection of data and study design in getting Prograf lung transplant indication. Use of real-world evidence in Opdivo trials had mixed results, BMS exec notes.
Horizon will gain the commercial product Uplizna and three pipeline products for rare diseases, where it can build on its success with Tepezza. Horizon is also interested in Viela's R&D team.