Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Novartis has filed the PD-1 inhibitor tislelizumab, licensed from BeiGene, for second-line esophageal cancer with the FDA, the first submission outside China for the closely-watched therapy.
US FDA Restricts JAK Inhibitors To Second-Line In Rheumatoid Arthritis Amid CV, Cancer, Mortality Risks
Now that the analysis of Pfizer’s postmarketing trial for Xeljanz is complete, though, application reviews of other products will likely be completed. The Xelijanz study revealed elevated risk of heart-related events, cancer, blood clots and death, resulting in a class-wide indication restriction and a revised boxed warning.
The Chinese biotech is set to extend the reach of its PD-1 candidate to the global market with a second major clinical win and following an earlier major deal with Novartis.