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Latest Denosumab Stories

2010-07-16 16:51:00

THOUSAND OAKS, Calif., July 16 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events (SREs) in patients with cancer. Filed in mid-May with the FDA, the Biologics License Application (BLA) submission summarizes clinical experience from nearly 6,900 patients across 18...

2010-06-05 07:09:00

THOUSAND OAKS, Calif., June 5 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3, head-to-head trial which compared the efficacy and safety of denosumab versus Zometa® (zoledronic acid) in 1,901 patients with hormone-refractory prostate cancer and bone metastases. The study met its primary and secondary endpoints and demonstrated denosumab's superiority over Zometa in delaying or preventing skeletal related events (SREs). These...

2010-06-05 07:08:00

THOUSAND OAKS, Calif., June 5 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced positive results from several new analyses of two Phase 3 trials studying denosumab compared with Zometa® (zoledronic acid), the current standard of care, for the treatment of bone metastases in patients with advanced breast cancer ("136 study") and solid tumors or multiple myeloma ("244 study"). Results from these trials reinforce denosumab's consistent ability to delay the...

2010-06-01 17:10:00

THOUSAND OAKS, Calif., June 1 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia(TM) (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK...

2010-06-01 16:21:00

SILVER SPRING, Md., June 1 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO ) Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the...

2010-05-28 03:34:00

THOUSAND OAKS, Calif., May 28 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the European Commission (EC) has granted marketing authorization for Prolia® (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 risk of fractures. Prolia has been approved in all 27 European Union member states...

2010-05-20 17:08:00

THOUSAND OAKS, Calif., May 20 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that results from studies involving nine molecules in the Company's oncology portfolio will be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4( )- 8, 2010 in Chicago. "Cancer is a complex disease that requires a comprehensive approach. Our goal is to help patients battle cancer by leveraging our understanding of cancer biology and pharmacogenomics to...

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...


Word of the Day
cenobite
  • One of a religious order living in a convent or in community; a monk: opposed to anchoret or hermit (one who lives in solitude).
  • A social bee.
This word comes from the Latin 'coenobium,' convent, which comes from the Greek 'koinobios,' living in community.
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