Amgen
Amgen Receives CHMP Positive Opinion for Prolia Denosumab in the European Union
Published in FDA Law Weekly, January 7th, 2010
Amgen Inc. (NASDAQ:AMGN) 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™ (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.
"Nearly two decades ago, Amgen researchers described a fundamental biochemical pathway that...
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Source: FDA Law Weekly (2010-01-07)
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