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News Breaks
November 27, 2012
05:12 EDTREGNRegeneron's Eylea Injection approved by European Commission
Regeneron Pharmaceuticals announced that Eylea Injection has been approved by the European Commission for the treatment of patients with neovascular, or wet, age-related macular degeneration, also known as wet AMD. According to the European Medicines Agency, or EMA, approved Summary of Product Characteristics, Eylea treatment is initiated with one 2 mg injection per month for three consecutive months, followed by one injection every two months. There is no requirement for monitoring by the physician between injections. After the first twelve months of treatment with Eylea, the treatment interval may be extended based on visual and anatomic outcomes. In such cases, the frequency of monitoring visits is determined by the treating physician and may be more often than the schedule of injections.
News For REGN From The Last 14 Days
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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.
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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