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Sanofi up 3%

  1. IAH2707

    52 Posts.
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    R&D Update
    Regulatory updates since the publication of the third-quarter 2014 results on October 28, 2014 include the following:
    • In January, the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for Praluent™ (alirocumab, in collaboration with Regeneron). In January, the U.S. Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for Praluent™. Praluent™ is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia.
    • In January, the rolling submission for Dengue vaccine was initiated in several endemic countries in Asia.
    • In December, Fluzone® Quadrivalent ID vaccine (a four-strain influenza vaccine which uses a microinjection system for intradermal delivery) was approved in the U.S.
    • In November, the FDA approved the supplemental biologics license application (sBLA) for Fluzone® High-Dose (Influenza Vaccine) to include efficacy data in the Prescribing Information. These data demonstrate that Fluzone® High-Dose vaccine provided improved protection against influenza compared to standard-dose Fluzone® vaccine (trivalent intramuscular formulation) in adults 65 years of age and older.
    • In November, the FDA granted Breakthrough Therapy designation for dupilumab, an investigational monoclonal antibody that blocks IL-4 and IL-13, two cytokines required for the Th2 immune response, for the treatment of adults with moderate-to-severe atopic dermatitis that are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.
    • In November, the FDA approved Lemtrada® (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis and who have had an inadequate response to two or more drugs.

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