Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Accelerated Approvals: Conversions Still Outweigh Withdrawals, But Takeda’s Exkivity Brings 2023’s Pull Count To Six
US FDA’s Oncologic Drugs Advisory Committee will convene in November for a ‘general discussion about delayed confirmatory trials’ and the ‘continued optimization of the accelerated approval process.’
Takeda Pays Big For De-Risked HutchMed CRC Drug
The Japanese pharma agreed to pay $400m up front plus up to $730m in milestones for a colorectal cancer drug already on the market in China and nearing regulatory filings in the US, EU and Japan.
Pricing Deals Spell Good News For Exkivity & Vimizin In England
Access to Takeda’s lung cancer drug, Exkivity, is being fast-tracked, and BioMarin’s Vimizin, for mucopolysaccharidosis type 4A, is switching to routine use after what the MPS Society called “a long and at times difficult journey.”