nov 17 2013
Regulators in Europe have given the green light to Bayer and Algeta's prostate cancer therapy Xofigo.
The marketing authorisation for Xofigo (radium Ra 223 dichloride) granted by the European Commission was expected given that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug in September. The alpha-pharmaceutical, which works by binding with minerals in the bone to deliver radiation directly to bone tumours, was approved by the US Food and Drug Administration in May.
http://www.pharmatimes.com/Article/13-11-17/Bayer_Algeta_prostate_cancer_drug_gets_Europe_OK.aspx
http://newdrugapprovals.wordpress.com/2013/09/21/xofigo-injection-recommended-for-approval-in-eu/
Regulators in Europe have given the green light to Bayer and Algeta's prostate cancer therapy Xofigo.
The marketing authorisation for Xofigo (radium Ra 223 dichloride) granted by the European Commission was expected given that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug in September. The alpha-pharmaceutical, which works by binding with minerals in the bone to deliver radiation directly to bone tumours, was approved by the US Food and Drug Administration in May.
http://www.pharmatimes.com/Article/13-11-17/Bayer_Algeta_prostate_cancer_drug_gets_Europe_OK.aspx
http://newdrugapprovals.wordpress.com/2013/09/21/xofigo-injection-recommended-for-approval-in-eu/