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Stock Market & Financial Investment News

News Breaks
February 28, 2014
08:03 EDTACT, SNYActavis confirms generic Multaq patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's (SNY) Multaq, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent AF. Sanofi and Sanofi-Aventis U.S. filed suit against Actavis on February 26 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until Jan. 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
News For ACT;SNY From The Last 14 Days
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January 27, 2015
17:04 EDTACTShire granted petitiion by U.S. Supreme Court
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January 26, 2015
17:34 EDTACTActavis registration statement for Allergan acquisition declared effective
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07:34 EDTACTActavis to acquire Auden Mckenzie for GBP306M accretive in FY15
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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
05:57 EDTACTActavis, Valeant raise prospects of more healthcare deals, Financial Times says
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05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
12:30 EDTACTGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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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.
07:22 EDTACTActavis price target raised to $330 from $280 at Deutsche Bank
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January 20, 2015
05:34 EDTACTActavis reports positive Phase III results for cariprazine
Gedeon Richter and Actavis announced positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia. There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses in the cariprazine group versus 47 relapses in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo.
January 14, 2015
18:18 EDTACTOn The Fly: After Hours Movers
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16:59 EDTACTGalena, Orexo AB receive "Paragraph IV" patent certification notice from Actavis
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