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Latest From Evive Biotech
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
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.
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.
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.
Company Information
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- Biotechnology
- Pharmaceuticals
- Other Names / Subsidiaries
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- Generon (Shanghai) Corporation Ltd
- Generon BioMed Holding Ltd.
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