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
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Immuno-oncology therapies have revolutionized the treatment of many cancers over the last decade. This period has also witnessed a dramatic growth in China’s domestic pharmaceutical industry, and significant changes in the interaction between this industry and international pharma. This coalescence has led to excitement about the role that Chinese IO could play on the global stage, tempered by regulatory set-backs and revised marketing timelines.
EU marketing authorization applications for 12 products, including Skycovion, trastuzumab duocarmazine, alpelisib and sparsenta, are now being evaluated by the European Medicines Agency.
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.