00:05 , Jul 27, 2019 |  BC Extra  |  Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
22:56 , Jun 28, 2019 |  BC Extra  |  Company News

CHMP knocks Evenity for osteoporosis, backs Giapreza for hypotension

EMA's CHMP issued a basket of opinions Friday, including a negative opinion for Amgen's osteoporosis drug Evenity, and a recommendation for La Jolla's hypotension therapy Giapreza. The agency recommended against approval of Evenity romosozumab-aqqg from...
00:23 , Apr 19, 2019 |  BC Week In Review  |  Company News

Amgen launches osteoporosis drug at $21,900 per treatment course

Amgen launched Evenity romosozumab-aqqg in the U.S. at $1,825 per month to treat osteoporosis in postmenopausal women at high risk of fracture. Amgen Inc. (NASDAQ:AMGN) said the list price for a full course of Evenity...
20:10 , Apr 9, 2019 |  BC Extra  |  Company News

FDA approves Evenity for osteoporosis

FDA approved Evenity romosozumab-aqqg from Amgen and UCB to treat osteoporosis in postmenopausal women at high risk of fracture. In January, an FDA advisory committee voted 18-1 in favor of the drug's approval (see "FDA...
16:39 , Apr 5, 2019 |  BC Week In Review  |  Company News

Hangzhou Just licenses Lilly’s bone disease program

Transcenta Holding’s subsidiary Hangzhou Just Biotherapeutics gained exclusive greater China rights from Lilly to develop and commercialize a portfolio of biologics, including blosozumab, for bone disease. Eli Lilly and Co. (NYSE:LLY) will receive an undisclosed...
00:54 , Jan 18, 2019 |  BC Week In Review  |  Clinical News

FDA panel backs Amgen's Evenity for osteoporosis

FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 18-1 in favor of Evenity romosozumab from Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) to treat osteoporosis in postmenopausal women at high risk of fracture. Amgen...
22:39 , Jan 16, 2019 |  BC Extra  |  Company News

FDA panel backs Amgen's Evenity for osteoporosis

FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 18-1 in favor of Evenity romosozumab from Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) to treat osteoporosis in postmenopausal women at high risk of fracture. Amgen...
21:02 , Dec 14, 2018 |  BC Week In Review  |  Company News

Mereo, OncoMed announce merger

Mereo BioPharma Group plc (LSE:MPH) announced a merger with OncoMed Pharmaceuticals Inc. (NASDAQ:OMED); the resulting entity will focus on development of Mereo's orphan disease pipeline and will be listed on London Stock Exchange and NASDAQ....
17:11 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

Amgen, UCB again seeking FDA nod for osteoporosis mAb

A year after receiving a complete response letter for Evenity romosozumab, Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) have resubmitted a BLA to FDA for the mAb to treat osteoporosis. During Evenity's initial FDA review...
20:22 , Jul 13, 2018 |  BC Extra  |  Company News

Amgen, UCB again seeking FDA nod for osteoporosis mAb

A year after receiving a complete response letter for Evenity romosozumab, Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) have resubmitted a BLA to FDA for the mAb to treat osteoporosis. During Evenity's initial FDA review...