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Stock Market & Financial Investment News

News Breaks
April 16, 2014
09:15 EDTSNY, IPXLImpax launches generic Renvela for kidney disease licensed from Sanofi
Impax Laboratories (IPXL) is commencing shipment of authorized generic Renvela 800 mg tablets, through Global Pharmaceuticals, Impax's generics division. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Under the terms of a settlement agreement, Sanofi (SNY) company Genzyme agreed to grant Impax a license to sell an allotment of a specified number of bottles of an authorized generic version of Renvela tablets commencing on April 16. Impax continues to pursue approval of its pending Abbreviated New Drug Application for generic Renvela with the FDA.
News For IPXL;SNY From The Last 14 Days
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January 30, 2015
06:55 EDTSNYSanofi having hard time finding new CEO, Reuters reports
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January 26, 2015
08:09 EDTIPXLImpax receives FDA approval for generic version of Lamictal tablets
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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 EDTSNYLeerink 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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