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 in...
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 FDA...
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 Evenity...
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 Phase...
07:00 , Oct 19, 2015 |  BC Week In Review  |  Clinical News

Abaloparatide-SC: Additional Phase III data

Additional data from the double-blind, international Phase III ACTIVE (Study BA058-05-003) trial in 2,463 postmenopausal women with severe osteoporosis showed that once-daily 80 ug abaloparatide-SC for 18 months reduced major osteoporotic fractures by 70% vs....
07:00 , Jun 22, 2015 |  BC Week In Review  |  Clinical News

Abaloparatide-SC: Extension study data

Top-line data from the 24-month, open-label, international ACTIVExtend extension trial of the double-blind, placebo-controlled, international Phase III ACTIVE (Study BA058-05-003) trial in 2,463 postmenopausal women with severe osteoporosis showed that once-daily 80 ug abaloparatide-SC for...
01:19 , Jun 19, 2015 |  BC Extra  |  Clinical News

Radius preparing NDA, MAA for osteoporosis treatment

Radius Health Inc. (NASDAQ:RDUS) gained $7.91 (15%) to $59.64 after it released six-month top-line data from the ACTIVExtend extension study and from a combined analysis of ACTIVExtend and the Phase III ACTIVE study of abaloparatide-SC...