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News Breaks
November 16, 2012
07:49 EDTREGN, SNYSanofi, Regeneron report Zaltrap receives CHMP positive opinion
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency adopted a positive opinion and recommended the granting of marketing authorization for Zaltrap Injection for Intravenous Infusion in combination with irinotecan/5-fluorouracil/folinic acid chemotherapy in adults with metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen. The European Commission now needs to ratify the positive opinion from CHMP to grant marketing authorization of Zaltrap in all 27 European Union member countries. A decision is expected from the European Commission in the first quarter of 2013. Zaltrap received approval from the U.S. Food and Drug Administration in August 2012 after Priority Review and marketing authorization applications for Zaltrap are under review with other regulatory agencies worldwide. In the U.S. Zaltrap is approved with the U.S. proper name ziv-aflibercept for use in combination with 5-fluorouracil, leucovorin, irinotecan, in patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.
News For SNY;REGN From The Last 14 Days
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December 22, 2014
06:34 EDTSNYImmunoGen appoints Richard Gregory as Chief Scientific Officer
ImmunoGen (IMGN) announced the appointment of Richard Gregory as Executive Vice President, Research and Chief Scientific Officer. Gregory will join the company on January 5, 2015, at which time current CSO, John Lambert, will assume the position of Executive Vice President, Distinguished Research Fellow. Gregory most recently served as senior vice president and head of research for the Sanofi (SNY) Genzyme Research & Development Center.
December 12, 2014
08:01 EDTREGNPiper predicts two large-cap biotechs could be acquired in 2015
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December 9, 2014
11:19 EDTSNYSanofi reportedly ready to make acquisitions in animal medicine, Bloomberg says
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