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Latest From Evive Biotech

EMA Turns Down Minoryx’s Orphan Drug Nezglyal & Apellis’ Syfovre, OKs Three Others

The European Medicines Agency has recommended against the pan-EU marketing approval of two new medicines, while three others received positive opinions on marketing authorization.

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US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19

CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.

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2023 Review: Chinese-Sponsored Phase III US Trials See Uptick

Companies from China single-handedly sponsored a total of eight Phase III clinical studies that included US sites in 2023 compared to six in 2022 - but the figure was still below the record of 11 in 2021.

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Deal Watch: Lilly Sends European Commercial Rights For Two Migraine Drugs To Organon

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Company Information

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  • Other Names / Subsidiaries
    • Generon (Shanghai) Corporation Ltd
    • Generon BioMed Holding Ltd.
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