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Latest Denosumab Stories

2010-05-14 15:03:00

THOUSAND OAKS, Calif., May 14 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denosumab, a subcutaneous RANK Ligand inhibitor. The BLA submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus...

2010-04-19 15:04:00

THOUSAND OAKS, Calif., April 19 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced results of a preclinical study demonstrating a positive response to administration of RANK-Fc against mammary tumor formation in mouse models. OPG-Fc and RANK-Fc bind to and block the action of RANKL. These molecules have a comparable mechanism of action to denosumab. The study was presented today in a late-breaking abstract at the American Association for Cancer Research (AACR) 101st Annual...

2010-02-19 17:06:00

THOUSAND OAKS, Calif., Feb. 19 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010. In October 2009, the...

2010-02-16 04:11:00

DALLAS, February 16, 2010 /PRNewswire/ -- - ReportsandReports announce to have Pipeline/Commercial Insight: Supportive Care in Oncology - Innovation and market growth limited to bone metastases management and emerging supportive care challenges ( http://www.reportsandreports.com/market-reports/pipeline-commercial-insight-s upportive-care-in-oncology-innova/) Market Research Report in its store (Due to the length of this URL, it may be necessary to copy and paste this hyperlink...

2010-02-08 17:20:00

THOUSAND OAKS, Calif., Feb. 8 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints. Denosumab demonstrated superiority over Zometa for both delaying the time to the first on-study skeletal related event (SRE) (fracture, radiation to bone, surgery...

2009-12-18 06:06:00

THOUSAND OAKS, Calif., Dec. 18 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for the marketing authorization of Prolia((TM)) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased...

2009-12-10 12:30:00

SAN ANTONIO, Dec. 10 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced further detailed results from a Phase 3, head-to-head trial of denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases in 2,046 patients with advanced breast cancer. In this trial denosumab met both primary and secondary endpoints and demonstrated superiority for both delaying the time to the first on-study skeletal related events (SRE) (fracture, radiation to bone, surgery to...

2009-12-10 12:30:00

An estimated 70 to 80 percent of patients with advanced or stage four breast cancer develop bone metastases. Bone metastases occurs when the disease progresses to a patient's bones. When cancer spreads to the bone, it can make the bones weaker resulting in skeletal complications like fractures. Results of a new treatment option for the treatment of bone metastases in patients with advanced breast cancer was recently presented at the 2009 San Antonio Breast Cancer Symposium (SABCS) in...

2009-11-23 14:05:00

THOUSAND OAKS, Calif., Nov. 23 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) was honored with two 2009 Scrip Awards, winning for Best Overall Pipeline and for Best New Drug for Nplate® (romiplostim), at a Nov. 18 ceremony in London. The Best Overall Pipeline award was presented to Amgen by Scrip in recognition of the size, quality, novelty and market potential of the company's pipeline, as well as its mix of candidates across development stages. According to the...

2009-10-19 07:00:00

THOUSAND OAKS, Calif., Oct. 19 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval. The Complete Response...


Word of the Day
jument
  • A beast of burden; also, a beast in general.
'Jument' ultimately comes from the Latin 'jugum,' yoke.
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