Tag Archives: UCB

July, 2018

13 July
Amgen and UCB Resubmit BLA for Evenity to the FDA for the Treatment of Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY increases bone …
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17 July
FDA Rejects Amgen’s Romosozumab for Treatment of Postmenopausal Women with Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, July 16, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY™* (romosozumab) as a treatment for postmenopausal women with osteoporosis. The original submission included data from the pivotal …
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22 May
Amgen, UCB Osteoporosis Drug Demonstrates Positive Efficacy but Serious Cardiac Risks in Late-Stage Trial

THOUSAND OAKS, Calif. and BRUSSELS, May 21, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced that the EVENITY™* (romosozumab) ARCH study met both primary endpoints and the key secondary endpoint. At the primary analysis, treatment with EVENITY for 12 months followed by alendronate significantly reduced …
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3 April
Amgen and UCB Report New Data Examining the Option of A Second Course Treatment with Evenity

THOUSAND OAKS, Calif. and BRUSSELS, April 1, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced results from the fourth year of a Phase 2 study showing the efficacy and safety of a second course of treatment with EVENITY™* (romosozumab), an investigational agent for postmenopausal women with osteoporosis. …
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19 September
In Late-Stage Study, Amgen and UCB’s Romosozumab Reduced Fractures in Older Women with Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, Sept. 18, 2016 /PRNewswire/ — Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced findings from the FRAME study showing that the investigational agent romosozumab significantly reduced the incidence of new vertebral fractures in postmenopausal women with osteoporosis through 12 and 24 months, meeting the …
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22 February
Amgen, UCB Osteoporosis Drug Succeeds in Late-Stage Trial

THOUSAND OAKS, Calif. and BRUSSELS, Feb. 22, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). These data showed FRAME met the co-primary endpoints by reducing the incidence of new vertebral fracture through …
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