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Osteoporosis

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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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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FDA Approves Radius’ Tymlos for Treatment of Postmenopausal Women with Osteoporosis

WALTHAM, Mass., April 28, 2017 (GLOBE NEWSWIRE) — Radius Health, Inc. (Nasdaq:RDUS), a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced that the US Food and Drug Administration (FDA) has approved TYMLOS (abaloparatide) injection for …

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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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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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Merck Discontinues Development of its Osteoporosis Candidate due to Stroke Risk

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that it is discontinuing the development of odanacatib, Merck’s investigational cathepsin K inhibitor for osteoporosis, and will not seek regulatory approval for its use. Merck previously reported a numeric imbalance in adjudicated stroke events in …

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Amgen Announces Positive Top-Line Results from Late-Stage Prolia Study

THOUSAND OAKS, Calif., Aug. 29, 2016 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced positive top-line results from the primary analysis conducted in a Phase 3 randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia® (denosumab) compared with risedronate in patients receiving glucocorticoid treatment. The study met all …

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Fewer Older Women with Hip Fractures Receive Osteoporosis Care

WASHINGTON, July 18, 2016 /PRNewswire-USNewswire/ — Fewer than 1 in 5 older women who break their hip have at least one of the recommended osteoporosis screening tests or treatments within six months, according to a new AARP Public Policy Institute (PPI) study. Women ages 80 and older who break a …

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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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Amgen Reacquires Rights to Three Drugs from GSK

THOUSAND OAKS, Calif., Dec. 14, 2015 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that it has entered into a definitive agreement with GSK to reacquire all of its remaining rights to Prolia® (denosumab), XGEVA®(denosumab) and Vectibix® (panitumumab) in 48 countries in Asia, South America, Europe, Australia and other regions throughout the world. …

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