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News Breaks
June 12, 2014
05:27 EDTSNY, REGNSanofi, Regeneron announce new data from positive sarilumab Phase 3 trial
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) presented positive results from a phase 3 trial of investigational drug sarilumab in rheumatoid arthritis patients who were inadequate responders to methotrexate therapy. New data presented at the meeting showed that sarilumab increased major clinical response rates defined as achieving an ACR70 for at least 24 consecutive weeks and showed sustained improvement in signs and symptoms of RA after 52 weeks, which were secondary endpoints of the trial. As previously announced, in this study, called SARIL-RA-MOBILITY, sarilumab met all three co-primary endpoints, demonstrating improvement in disease signs and symptoms at 24 weeks, physical function at 16 weeks and inhibition of joint damage progression at 52 weeks. The SARIL-RA-MOBILITY Phase 3 trial enrolled 1,197 adult patients with active, moderate-to-severe rheumatoid arthritis, who were inadequate responders to MTX therapy. Patients were randomized to one of three treatment groups dosed subcutaneously every other week, sarilumab 150 milligrams, sarilumab 200 mg, or placebo, all in combination with MTX. Both sarilumab groups showed statistically significant improvements compared to the placebo group in all three co-primary endpoints.
News For SNY;REGN From The Last 14 Days
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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 EDTREGN, SNYRegeneron, 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 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTREGN, SNYLeerink 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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