January 6, 2016 Overseas Medicine Morning Post

CTI biopharmaceuticals and baxalta completed rolling NDA of JAK2 / FLT3 / irak1 / csf1r kinase inhibitor pacitinib in the treatment of myelofibrosis (platelet count per microliter is less than 50000) CTI biopharmaceuticals submitted rolling NDA to FDA on November 23, 2015, and applied for fast track qualification in 2014 based on the results of phase III clinical study of persist-1 [CTI biopharma and baxalta complete submission of new drug application for pacitinib for unmet medical need in myelofibrosis] http://t.cn/r4a3wcx FDA awarded Ionis pharmaceutical's Huntington protein inhibitor ionis-htt RX the qualification for treating Huntington's chorea orphan drug [Ionis pharmaceuticals receives orphan drug design from the US FDA for ionis-htt Rx for the treatment of patients with Huntington's disease] http://t.cn/r4a3ydg FDA grants steadymed company the qualification of trevyen for the treatment of pulmonary hypertension orphans [steadymed receives orphan drug design for trevyen for the treatment of pulmonary artistic hypertention] http://t.cn/r4a35tn mankind has terminated the cooperation with Sanofi in the development and commercialization of inhaled insulin afrezza, which shall take effect within 6 months at the latest Mannkind's shares fell nearly 50% [announcements termination of license and collaboration agreement with Sanofi] http://t.cn/r4a3fhg two phase III clinical studies (108 and 110 Studies) on the treatment of chronic hepatitis B infection (TAF) reached the main end point, which was not inferior to the listed hepatitis B drug Viread (TDF), and had better renal and bone safety Gillette plans to submit the application for the indication to FDA and EMA in the first quarter of 2016 [Gilead announcements top line results from two phase 3 students evaluating tenofovir alafinade (TAF) for patients with chronic hepatis B infection] http://t.cn/r4a3xrc states: if the original news needs to be reproduced, please indicate the source!