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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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October 29, 2014
06:00 EDTSNYSanofi downgraded to Neutral from Buy at BofA/Merrill
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05:29 EDTSNYSanofi downgraded to Hold from Buy at Deutsche Bank
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05:28 EDTSNYSanofi downgraded to Equal Weight from Overweight at Barclays
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05:28 EDTSNYSanofi downgraded to Hold from Buy at Jefferies
Jefferies downgraded Sanofi to Hold following the company's Q3 results.
05:27 EDTSNYSanofi board removes Christopher Viehbacher as CEO
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October 28, 2014
10:53 EDTSNYSanofi sees pricing pressure, competition in diabetes sector
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09:20 EDTSNYOn The Fly: Pre-market Movers
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05:40 EDTSNYSanofi reports Q3 business EPS EUR 1.47 vs. EUR 1.36 last year
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October 27, 2014
07:23 EDTSNYAmerican College of Surgeons holds a conference
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07:21 EDTSNYSanofi board explains CEO development not included in meeting, Reuters says
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October 24, 2014
08:04 EDTREGNRegeneron price target raised to $460 from $350 at Canaccord
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October 22, 2014
07:35 EDTSNYCardiometabolic Health Congress to hold annual meeting
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October 21, 2014
07:06 EDTSNYFierce Biotech to hold a breakfast meeting
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06:44 EDTSNYActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the productís U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
08:06 EDTSNYMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:19 EDTSNYIBC Life Sciences to hold a conference
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07:16 EDTREGNAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
07:10 EDTREGN, SNYAmerican Society of Human Genetics to hold annual meeting
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07:02 EDTSNY, REGNRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
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