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Latest Denosumab Stories

2009-08-14 11:07:47

Amgen's bone drug, denosumab, has been partially endorsed by an advisory committee to the U.S. Food and Drug Administration, officials said. In a unanimous vote Thursday, the committee said denosumab should be approved to treat post menopausal women with osteoporosis, The New York Times reported Friday. However, the committee voted 12 to 3 against denosumab being used to prevent osteoporosis in women with moderately low bone density, and it opposed three of four possible uses for prostate and...

2009-08-13 17:37:00

THOUSAND OAKS, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) issued the following statement on the outcome of today's meeting with the U.S. Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD) to review the potential use of Prolia(TM) (denosumab) for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate cancer or breast...

2009-08-13 06:52:00

THOUSAND OAKS, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today will summarize data from the submitted Biologic License Applications (BLAs) for denosumab for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in breast and prostate cancer patients undergoing hormone ablation at a meeting with the U.S. Food and Drug Administration's (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD). "There remains...

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2009-08-12 14:52:34

Studies suggest that a first-of-its-kind osteoporosis drug lowers the risk of bone fractures better than some existing treatments and could soon add a more expensive but easier option to the booming market, The Associated Press reported. Amgen Inc's genetically engineered denosumab only requires two shots a year and could be approved for sale this fall. Many osteoporosis patients stop taking other drugs due to side effects or frequent dosing. But doctors say denosumab's high cost may be a...

2009-08-11 09:05:00

THOUSAND OAKS, Calif., Aug. 11 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced the publication of results from two pivotal Phase 3 studies investigating the safety and effectiveness of denosumab at reducing fracture risk in more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with non-metastatic prostate cancer undergoing androgen deprivation therapy (ADT) leading to bone loss. In both studies, published today in The New England Journal of...

2009-08-11 10:12:11

Twice-yearly treatment with denosumab, a new targeted therapy to stop bone loss, increased bone density and prevented spinal fractures in men receiving androgen-deprivation therapy for prostate cancer. The report from an international research study, the first to document reduced fracture risk in men receiving the hormone-blocking treatment, will appear in the August 20 New England Journal of Medicine and is receiving early online release."Androgen-deprivation therapy is the standard...

2009-08-03 16:03:00

THOUSAND OAKS, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced positive top-line results from a pivotal Phase 3 head-to-head trial evaluating denosumab administered subcutaneously versus Zometa((R)) (zoledronic acid) administered as an intravenous (IV) infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma. For the primary endpoint, patients treated...

2009-07-27 15:08:00

THOUSAND OAKS, Calif. and LONDON, July 27 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) and GlaxoSmithKline (GSK) today announced a collaboration in which the companies will share commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico once the product is approved in these countries. Amgen will commercialize the drug for PMO and oncology in the United States (U.S.) and Canada and for all oncology...

2009-07-07 16:29:00

THOUSAND OAKS, Calif., July 7 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events (SREs)(fracture,...

2009-06-22 14:29:00

Advisory Committee to Review Denosumab Data THOUSAND OAKS, Calif., June 22 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has asked the company to participate in a meeting of the Reproductive Health Drugs Advisory Committee (RHDAC) on Aug. 13, 2009. The RHDAC will review data supporting the Biologics License Application (BLA) for denosumab, a RANK Ligand inhibitor for which Amgen is seeking approval for prevention and...


Word of the Day
mallemaroking
  • Nautical, the visiting and carousing of sailors in the Greenland ships.
This word is apparently from a confusion of two similar Dutch words: 'mallemerok,' a foolish woman, and 'mallemok,' a name for some persons among the crew of a whaling vessel.