19:15 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review during the beginning Feb. 18, according to company announcements. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib...
22:39 , Feb 19, 2019 |  BC Extra  |  Company News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review, according to company announcements early this week. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib and polatuzumab...
22:32 , Aug 16, 2018 |  BC Extra  |  Company News

Management tracks: Achillion, Navidea

Rare disease company Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) hired Anthony Gibney as EVP and CBO. He was managing director and co-head of the biotechnology investment banking team at Leerink Partners. Immunotherapy company Navidea Biopharmaceuticals Inc. (NYSE-A:NAVB;...
18:31 , Nov 18, 2016 |  BC Week In Review  |  Clinical News

Biosimilar teriparatide regulatory update

EMA's CHMP recommended approval of Terrosa/Movymia, a biosimilar of osteoporosis drug Forsteo teriparatide from Eli Lilly and Co. (NYSE:LLY, Indianapolis, Ind.). The biosimilar is under review to treat osteoporosis in postmenopausal women and in men...