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Last updated on April 17, 2014 at 15:50 EDT

Latest Denosumab Stories

2011-07-15 06:01:00

THOUSAND OAKS, Calif., July 15, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has granted marketing authorization for XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. This approval of XGEVA applies to all 27 European Union (EU) member states. The EC also granted XGEVA...

2011-06-27 15:37:00

THOUSAND OAKS, Calif., June 27, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or delay the spread of cancer to the bone. The...

2011-05-20 06:30:00

THOUSAND OAKS, Calif., May 20, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a positive opinion for the marketing authorization of XGEVA(TM) (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. If approved by the...

2011-05-17 15:01:00

THOUSAND OAKS, Calif., May 17, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced primary results of a pivotal Phase 3 trial ('147) demonstrating that XGEVA(TM) (denosumab) significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone. Full results of the '147 study were presented for the first time today in a late-breaking plenary session at the American Urological...

2011-04-21 08:00:00

NEW YORK, April 21, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today outlined the Company's strategy, capital allocation plans and provided financial guidance for 2015 during a meeting with investors in New York. Kevin Sharer, chairman & CEO opened the meeting by outlining key elements of the Company's strategy: Bring medicines to market that advance treatment of serious illness; Make significant and sustained investment in research and development (R&D) and participate in a...

2011-03-23 15:06:00

THOUSAND OAKS, Calif., March 23, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced new long-term data showing that during the fourth and fifth years of Prolia® (denosumab) treatment, postmenopausal women with osteoporosis receiving Prolia continued with further, statistically significant, year-over-year increases in lumbar spine and total hip bone mineral density (BMD), a key measurement of bone strength. The overall adverse event profile was similar for the...

2011-03-23 15:05:00

THOUSAND OAKS, Calif., March 23, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced new data that showed postmenopausal women with osteoporosis had significantly greater adherence, compliance, and persistence during Prolia® (denosumab) treatment than during alendronate treatment, an oral bisphosphonate commonly used to treat osteoporosis. Adherence to treatment, which includes both compliance (a measure of how well patients follow directions for taking...

2011-03-22 15:15:00

NEW YORK, March 22, 2011 /PRNewswire/ -- A study in the prostate cancer space completed this week by ITG's Majestic Market Research reveals that Amgen's (Nasdaq: AMGN) Xgeva (a.k.a. denosumab, Prolia) is on track to achieve its blockbuster sales potential and is already stealing share from the leading agent for skeletal related events, Novartis' (NYSE: NVS) Zometa. As for Dendreon's (Nasdaq: DNDN) Provenge, the first FDA-approved therapeutic cancer vaccine, physicians are still clouded...

2011-02-24 18:05:00

THOUSAND OAKS, Calif., Feb. 24, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA(TM) (denosumab) to Zometa(®) (zoledronic acid) in preventing bone complications called skeletal-related events (SREs) in 1,901 men with prostate cancer and bone metastases. The study, published in The Lancet, met its primary and secondary endpoints and demonstrated XGEVA's superiority compared to Zometa...

2011-02-22 15:05:00

THOUSAND OAKS, Calif., Feb. 22, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors (not including breast and prostate cancer) or multiple myeloma, which compared XGEVA(TM) (denosumab) to Zometa® (zoledronic acid) in preventing skeletal-related events (SREs). The study, which appeared today in the Journal of Clinical Oncology, found that...