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June 11, 2014
05:36 EDTBAYRY, REGNRegeneron, Bayer submit Eylea Injection for EU marketing authorization
Regeneron Pharmaceuticals (REGN) and Bayer HealthCare (BAYRY) announced that Bayer HealthCare has submitted an application to the European Medicines Agency seeking marketing authorization in the European Union for Eylea Injection for the treatment of macular edema following branch retinal vein occlusion, or BRVO. The EMA submission is based on the positive Phase 3 VIBRANT trial, a double-masked, randomized, active-controlled study of patients with macular edema following BRVO. In the VIBRANT study, 53% of patients who received EYLEA 2 milligram monthly gained at least 15 letters in best-corrected visual acuity, or BCVA, from baseline at week 24, the primary endpoint of the study, compared to 27 of patients who received laser, a standard of care treatment. In addition, EYLEA met a key secondary endpoint, achieving a 17.0 letter mean improvement over baseline in BCVA compared to a 6.9 letter mean improvement in patients who received laser.
News For REGN;BAYRY From The Last 14 Days
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June 26, 2015
05:25 EDTBAYRY, REGNRegeneron reports approval of Eylea by Japan
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June 25, 2015
14:01 EDTBAYRYBayer initiated with a Buy at HSBC
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08:00 EDTBAYRYBayer to hold a meeting
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June 23, 2015
10:31 EDTBAYRYMonsanto says Bayer crop chemicals unit an option, Bloomberg reports
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