New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 10, 2014
07:32 EDTREGNRegeneron, Bayer announce positive Phase 3 Eylea trial results
Regeneron and Bayer HealthCare announced that in the Phase 3 VISTA-DME trial of EYLEA Injection for the treatment of diabetic macular edema, EYLEA 2 milligrams dosed monthly and EYLEA 2 mg dosed every two months showed a sustained improvement from baseline in best corrected visual acuity at week 100, compared to laser photocoagulation. After two years, patients receiving EYLEA 2Q4 had a mean change from baseline in BCVA of 11.5 letters. Patients receiving EYLEA 2Q8 had a mean change from baseline in BCVA of 11.1 letters. Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.9 letters. In this trial, EYLEA was generally well tolerated with a similar overall incidence of adverse events, ocular serious AEs, and non-ocular serious AEs across the EYLEA treatment groups and the laser control group. Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA.
News For REGN From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
January 30, 2015
06:34 EDTREGNObama to propose $215M for major medical program, CNBC says
Subscribe for More Information
January 29, 2015
09:07 EDTREGNHead researchers of Vertex, Regeneron, Merck invited to White House, CNBC says
Subscribe for More Information
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
Subscribe for More Information
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.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use