January 15, 2016 overseas medical morning post

Biomarin received the FDA's full response letter on drisapersen, a DMD drug, whose PDUFA date was December 27, 2015 The FDA has postponed to January, but it still hasn't approved it Sarepta and the DMD drug eteplirsen will hold an Advisory Committee on January 22, and PDUFA will be held on February 26 The fate of Sarepta is unknown PTC pharmaceutical ataluren has entered the FDA review Ataluren is the only DMD drug on the market in the world, which is listed in some European countries [FDA issues complete response letter for kyndrisatm for Duchenne muscular dystrophy amenable to exon 51 skipping] http://t.cn/r4wga1q FDA accepts 505 (b) (2) NDA resubmitted by ADAMIS pharmaceutical precharged adrenaline syringe In March 2015, FDA issued a full response letter, saying ADAMIS is needed to improve CMC data, but there is no defect in safety and effectiveness The new PDUFA is dated June 4, 2015 [ADAMIS pharmaceuticals announcements FDA acceptance of permission of its epiephrine pre filled syringe NDA] http://t.cn/r4wjyp8 statement: if the original news needs to be reproduced, please indicate the source!