BC Extra | Jan 23, 2020
Company News

With established foothold in Japan, Amgen takes over JV from Astellas

Amgen will take over full ownership of the 2013 JV it launched with Astellas in Japan but the two will continue to co-promote Amgen’s three drugs in the country. The U.S. biotech has used its...
BC Extra | Dec 14, 2019
Company News

Dec. 13 Company Quick Takes: Horizon, Intercept, Imfinzi, Evenity and Numab-3SBio

FDA panel backs Horizon's eye disease candidate  FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously Friday that the benefits of teprotumumab to treat active thyroid eye disease outweigh the potential risks. The mAb against...
BC Extra | Oct 19, 2019
Company News

CHMP backs Merck’s Ebola vaccine, a first

EMA’s CHMP issued its first positive opinion for an Ebola vaccine and backed AbbVie’s rheumatoid arthritis treatment. The agency recommended approving Ervebo (rVSV-ZEBOV) from Merck & Co. Inc. (NYSE:MRK), to prevent infection by the Ebola...
BC Extra | Jul 27, 2019
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...
BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BC Extra | Jun 28, 2019
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...
BC Week In Review | Apr 19, 2019
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...
BC Extra | Apr 9, 2019
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...
BC Week In Review | Jan 18, 2019
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...
BC Extra | Jan 16, 2019
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...
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