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Last updated on April 16, 2014 at 1:21 EDT

Latest Zoledronic acid Stories

2010-11-19 08:30:00

SILVER SPRING, Md., Nov. 19, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration approved Xgeva (denosumab) on Thursday to help prevent skeletal-related events (SREs) in patients with cancer that has spread (metastasized) and damaged the bone. Skeletal-related events include bone fractures from cancer and bone pain requiring radiation. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Xgeva is a monoclonal antibody that targets a protein involved in...

2010-11-18 18:41:00

THOUSAND OAKS, Calif., Nov. 18, 2010 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved XGEVA(TM) (denosumab), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was approved following a 6 month priority review by the FDA, a designation reserved for drugs that offer major advances in treatment or provide a...

2010-11-08 15:27:00

THOUSAND OAKS, Calif., Nov. 8, 2010 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced the publication of results from a pivotal Phase 3 study of 2,046 patients which compared denosumab with Zometa® (zoledronic acid) in delaying or preventing skeletal-related events (SREs) in breast cancer patients with bone metastases. An SRE consists of any of the following: a pathologic fracture, the need for radiation or surgery to ameliorate bone pathology secondary to...

2010-10-16 15:45:00

EAST HANOVER, N.J., Oct. 16 /PRNewswire/ -- Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast® (zoledronic acid) injection in postmenopausal women with osteoporosis.(1) The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada. The study showed that Reclast maintained bone mass in...

2010-10-13 12:29:00

Labeling change adds warning about possible risks of long-term use of osteoporosis drugs SILVER SPRING, Md., Oct. 13 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk. (Logo:...

2010-10-10 05:56:00

THOUSAND OAKS, Calif., Oct. 10 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced results from two integrated analyses of head-to-head pivotal Phase 3 trials comparing denosumab to Zometa® (zoledronic acid), the current standard of care in the prevention of skeletal related events (SREs) in patients with advanced malignancies involving bone. In these separate analyses, denosumab demonstrated a clinically meaningful, consistent and robust treatment effect...

2010-09-14 18:32:36

Expert panel calls for additional product labeling, international patient registry A widely prescribed class of drugs is highly effective in reducing common bone fractures in people with osteoporosis, but an expert panel announced today that these same drugs "“ when used long term "“ may be related to unusual but serious fractures of the thigh bone. In the most comprehensive scientific report to date on the topic, the task force reviewed 310 cases of "atypical femur fractures,"...

2010-06-05 07:27:00

EAST HANOVER, N.J., June 5 /PRNewswire/ -- New data to be presented tomorrow at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, show that the addition of Zometa® (zoledronic acid) to first-line chemotherapy significantly improved overall survival for newly diagnosed multiple myeloma patients by 16% (P=0.0118) and progression-free survival by 12% (P=0.0179) compared with oral clodronate plus first-line chemotherapy(1). The 5.5...

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...