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News Breaks
November 16, 2012
07:49 EDTSNY, REGNSanofi, 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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September 17, 2014
06:18 EDTSNYSanofi, MyoKardia announce collaboration
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September 16, 2014
07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTREGNRegeneron's EYLEA Injection granted designation for treatment of retinopathy
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September 12, 2014
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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September 11, 2014
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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September 8, 2014
14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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07:15 EDTREGNIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.

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