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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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January 26, 2015
05:14 EDTREGN, SNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 23, 2015
07:39 EDTREGNRegeneron announces EYLEA Injection recommended for approval in EU
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January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTREGN, SNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 14, 2015
06:36 EDTREGNRegeneron price target raised to $474 from $390 at Citigroup
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January 13, 2015
13:50 EDTREGNRegeneron sees FY14 EYLEA U.S. sales about $1.735B
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12:40 EDTREGNAmgen off highs after Express Scripts CEO talks PCSK9 costs
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