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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Jazz/PharmaMar’s SCLC drug will stay on the market while two more trials with different designs are conducted after confirmatory trial did not meet overall survival endpoint. Citizen petition requesting agency withdraw lurbinectedin underscores vagaries of accelerated approval.
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.