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June 11, 2014
05:36 EDTREGN, BAYRYRegeneron, 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.
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August 18, 2014
07:57 EDTREGNCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 11, 2014
07:07 EDTREGNRegeneron reports Q2 EPS 9c, consensus 6c
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05:32 EDTBAYRY, REGNRegeneron Eylea injection receives EU approval for DME treatment
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August 7, 2014
17:12 EDTREGNRegeneron reports 8.1% passive stake in Avalanche Biotechnologies
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