Keeping Track: Cloudy Horizon For Teplizumab, Roxadustat; Nuplazid Stumbles Over Subgroups; CAR-T Submissions From Gilead, J&J
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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While much earlier in its development, the drug may be able to rival Gilead’s Trodelvy, which also targets TROP2 and showed similar response rates.
Bouncing back from the pandemic more strongly than its peers, AbbVie sees 40% growth for Botox and Juvederm, a good launch for Ubrelvy and continued strength from its mainstays.
Roxadustat Approval Might Hinge On Additional Safety Analyses After FibroGen Admits Manipulating Data
With superiority over epoetin apparently off the table, FibroGen and AstraZeneca expect a US FDA advisory committee in July, and hope that additional safety analyses for roxadustat will help support a positive overall risk-benefit profile.