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News Breaks
July 29, 2014
18:38 EDTREGNRegeneron receives FDA approval for EYLEA for treatment of DME
Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment of Diabetic Macular Edema, or DME. The approval of EYLEA in DME was based on the one-year data from the phase 3 VISTA-DME and VIVID-DME studies of 862 patients. In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for EYLEA in the treatment of DME. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia. A regulatory submission has been made in the U.S. and Europe for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion.
News For REGN From The Last 14 Days
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January 30, 2015
06:34 EDTREGNObama to propose $215M for major medical program, CNBC says
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January 29, 2015
09:07 EDTREGNHead researchers of Vertex, Regeneron, Merck invited to White House, CNBC says
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January 26, 2015
05:14 EDTREGNRegeneron, 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 21, 2015
10:16 EDTREGNLeerink 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.

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