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News Breaks
January 31, 2014
11:32 EDTLLY, SNYEli Lilly does not believe new insulin glargine product infringes Sanofi patents
Eli Lilly (LLY) provided a statement regarding a lawsuit filed by Sanofi (SNY) in the United States District Court for the District of Delaware alleging patent infringement with respect to LY2963016, a new insulin glargine product for which Lilly is currently seeking approval from the U.S. Food and Drug Administration. Lilly's general patent counsel said, "Lilly respects the intellectual property of others and does not believe the application for approval of its new insulin glargine product infringes any valid claim of the asserted patents." Lilly, and its alliance partner Boehringer Ingelheim, recently announced the FDA had accepted the filing of the New Drug Application for LY2963016, an investigational basal insulin, the company noted.
News For LLY;SNY From The Last 14 Days
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January 26, 2015
05:14 EDTSNYRegeneron, 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 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTSNY, LLYLeerink 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 15, 2015
11:20 EDTLLYGoldman cuts J&J to sell citing competitive pressures
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10:00 EDTLLYOn The Fly: Analyst Upgrade Summary
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07:07 EDTLLYEli Lilly upgraded at Goldman
As previously reported, Goldman upgraded Eli Lilly to Neutral from Sell. The firm upgraded shares based on new product launches and pipeline assets, and cost reductions. Price target is $70.
06:44 EDTLLYEli Lilly upgraded to Neutral from Sell at Goldman
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