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Keeping Track: US FDA Approvals Include Novel Agents Zepzelca And Uplizna, Biosimilar Nyvepria, Follow-On Semglee

Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Failed Confirmatory Trial Won’t Force Withdrawal Of Zepzelca’s Accelerated Approval, US FDA Says

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.

Asia Deal Watch: CJ Group Continues Spree With Majority Stake Acquisition In Batavia Biosciences

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.

What Astellas Did Right In Using Real-World Evidence For Prograf Approval

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.

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