Friday, December 18, 2009
Amgen Receives CHMP Positive Opinion for Prolia(TM) (Denosumab) in the European Union
THOUSAND OAKS, Calif. – Dec 18, 2009 – 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 risk of fractures. If approved by the European Commission, Amgen would receive marketing authorization for Prolia in all European Union (EU) Member States.
Read the rest of this entryPosted in Press Releases
Wednesday, December 16, 2009
Amgen Issues Statement on Update to U.S. Prescribing Information for Erythropoiesis-Stimulating Agents (ESAs)
On December 16, 2009, Amgen updated the boxed warning in the labeling information for the class of drugs known as erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), to reflect an increased risk of stroke when ESAs are administered to chronic renal failure patients to target hemoglobin levels of 13 g/dL and above. The update was made based on results from the recently completed clinical study, TREAT (the Trial to Reduce Cardiovascular Events with Aranesp Therapy), a large, randomized, double-blind, placebo-controlled, Phase 3 pivotal study of patients with chronic kidney disease (CKD) not on dialysis, moderate anemia and type-2 diabetes. In addition, the Warnings section has been updated to include a description of TREAT and the increased risk of stroke found in the study.
Read the rest of this entryPosted in Company Statements
Thursday, December 03, 2009
New Amgen Scholars Web site Launches to Build a Global Network for Future Scientists
THOUSAND OAKS, Calif. (Dec. 3, 2009) – Each year, hundreds of undergraduate students from across the United States (U.S.) and Europe participate in the Amgen Scholars Program to gain hands-on laboratory experience under renowned faculty members at the world’s leading universities. Now, the Amgen Scholars – past, present and future – will have exclusive access to the online Amgen Scholars Community at www.amgenscholars.com.
Read the rest of this entryPosted in Press Releases
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