BeiGene/Novartis's Tislelizumab Faces US Delay Over China Inspection Challenges
No Timetable in Sight
An inability to conduct manufacturing field inspections in China due to strict local COVID-19 policies is cited as the only reason for the delay for the anti-PD-1 drug, for which the timescale for resolution is currently unclear.
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Keeping Track: Longer US FDA Reviews For Tislelizumab, Toripalimab, Olipudase; Perrigo Wants OC To Go OTC
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.
Chinese drug makers have more to lament and plenty to learn from as Junshi, HutchMed follow Innovent Bio with FDA rejections. A holistic not opportunistic approach is needed, one ex-FDA expert suggests.