The troubled development program for ataluren took another turn for the worse when the phase III Ataluren Confirmatory Trial (ACT CF) in nonsense mutation cystic fibrosis (nmCF) fell short across the board, missing both primary and secondary endpoints. Developer PTC Therapeutics Inc. said it was halting development of ataluren in CF. Read More
Women whose HER2-positive early breast cancers were treated with Genentech Inc.'s Herceptin (trastuzumab) and chemotherapy after surgery saw greater risk reductions for invasive disease recurrence or death when Perjeta (pertuzumab) was added to treatment, a phase III study found. Read More
Myovant Sciences Inc.'s kickoff to 2017 with a phase III trial testing its oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix in uterine fibroids (UFs) signaled a year of tighter focus on the condition, with a group of heavyweight drug developers involved in that indication as well as endometriosis. Read More
HONG KONG – The prolonged pending time for drug approvals in China that has long been a thorn in the side of drug- and medical device-makers should be drastically cut this year, as regulators take steps to become more efficient and shorten procedures. Read More
Kite Pharma Inc., of Santa Monica, Calif., priced its public offering of 4.75 million shares of its common stock at $75 each. The offering is expected to close on or about March 7. Read More
Engeneic Ltd., of New York, said the FDA granted orphan drug designation to EGFR-targeted, doxorubicin-loaded EDV nanocells for the treatment of glioblastoma multiforme. Read More
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, reported top-line results from its phase IIb AURA-LV study in lupus nephritis, showing that, at 48 weeks, the trial met the complete remission (CR) and partial remission (PR) endpoints, demonstrating statistically significantly greater CR and PR in patients in both low-dose (23.7 mg of voclosporin twice daily [p Read More
