23:23 , Jan 11, 2019 |  BioCentury  |  Politics, Policy & Law

Supreme Court may reset FDA-State power balance

Following oral arguments in Merck v. Albrecht on Jan. 7, the Supreme Court is pondering a decision that could reset the balance of power over drug label warnings between FDA and state courts. The outcome...
22:18 , Jan 7, 2019 |  BC Extra  |  Politics & Policy

Supreme Court hears Merck label preemption case

Merck & Co. Inc. (NYSE:MRK) received support during oral arguments Monday from at least four Supreme Court justices regarding its position that FDA’s rejection of a proposed warning about the company’s Fosamax alendronate precludes failure-to-warn...
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...
18:46 , Jul 21, 2017 |  BC Week In Review  |  Clinical News

Amgen/UCB osteoporosis therapy gets CRL

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) said FDA issued a complete response letter for Evenity romosozumab (CDP7851, AMG 785) to treat osteoporosis in postmenopausal women. Amgen said in May that it no longer expected...
21:52 , Jul 17, 2017 |  BC Extra  |  Company News

Amgen/UCB osteoporosis therapy gets CRL

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) said FDA issued a complete response letter for Evenity romosozumab to treat osteoporosis in postmenopausal women. Amgen said in May that it no longer expected FDA to approve...
17:17 , May 26, 2017 |  BC Week In Review  |  Clinical News

Amgen, UCB report CV safety signal in Phase III of osteoporosis candidate Evenity

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) no longer expect FDA to approve Evenity romosozumab (AMG 785, CDP7851) this year after data from the Phase III ARCH trial in 4,093 postmenopausal women with osteoporosis at...
23:09 , May 22, 2017 |  BC Extra  |  Clinical News

CV signal in osteoporosis trial sinks UCB, Amgen shares

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) no longer expect FDA to approve Evenity romosozumab this year after new data from the Phase III ARCH trial revealed a previously unseen cardiovascular safety signal in postmenopausal...
08:00 , Mar 7, 2016 |  BioCentury  |  Product Development

Getting hip in osteoporosis

Investors were quick to conclude that Amgen Inc. and UCB Group's romosozumab may be at a disadvantage in the osteoporosis market after the partners reported a miss on non-vertebral fracture rates, and an apparently lower...
02:39 , Feb 23, 2016 |  BC Extra  |  Clinical News

Amgen, UCB pass second Phase III osteoporosis test

Amgen Inc. (NASDAQ:AMGN) and partner UCB Group (Euronext:UCB) said romosozumab ( AMG 785 ) met the co-primary endpoints of significantly reducing the incidence of new vertebral fracture through months 12 and 24 in the 7,180-patient...