Zydus Looks To NASH Trials In Turkey, Generic Vascepa Launch In The US
Generic Versions Of Revlimid And Trokendi Drive Record US Sales
Zydus, the only Indian company with an NCE for a range of chronic liver diseases, will add Turkey to the list of trial locations for NASH. It is also working “aggressively” to launch a generic to Amarin’s Vascepa after Revlimid and Trokendi generics drove record US sales in the fourth quarter.
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Drug shortages, stable prices and a demand recovery in the US helped drive Aurobindo’s growth in Q4. Meanwhile, the company is developing a biosimilar to Roche/Novartis’s multi-billion product Xolair. Use of decentralized mode for its Phase III trials is a notable aspect.
An FDA advisory committee’s “no” votes for Intercept’s obeticholic acid in non-alcoholic steatohepatitis could augur tough reviews for other NASH candidates. But some could enjoy smoother regulatory tides than OCA.
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