What Does The Negative FDA Review For Intercept’s OCA Hold For Other NASH Drugs?
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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While Intercept is calling it quits in NASH with its FXR agonist obeticholic acid following a second complete response letter, other companies are staying the course with Phase II molecules in the class.
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.
In this week's podcast edition of Five Must-Know Things: novel BMS drug shows promise in IPF; Novo’s oral semaglutide compares well with injectable in weight loss; Teva looks to innovative brands to return to growth; US setback for Intercept’s NASH drug; and India’s improving environment for clinical trials.