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Latest From AbbVie Inc.
Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker
Round Two: BioMarin Resubmits Hemophilia A Gene Therapy Roctavian In US
BioMarin maintains its lead in the race to win approval for a hemophilia A gene therapy in the US by resubmitting Roctavian two years after the FDA issued a CRL in response to the original BLA.
Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint
Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.
China Drug Price Negotiations: Another Race To The Bottom？
With the fourth quarter just around the corner, China's closely-watched annual drug reimbursement and prices negotiations are entering a key final stage. But will applicants need to be more strategic than expedient?
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