• 9/20/19 7:05 am EDT
    CAMBRIDGE and TARRYTOWN, NY--

    The Lancet published detailed positive results from two Phase 3 trials evaluating the safety and efficacy of Dupixent® (dupilumab) in adults with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) despite previous treatment with surgery and/or systemic corticosteroids.

    Results published in The Lancet demonstrated that adding Dupixent to the standard-of-care corticosteroid nasal spray reduced nasal polyp size and nasal congestion severity (co-primary endpoints). Dupixent also reduced chronic sinus disease associated with nasal polyps and improved sense of smell.

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  • 9/20/19 6:50 am EDT
    PARIS and TARRYTOWN, NY--

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab) in a third indication. The CHMP recommended Dupixent be approved as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.  If approved, Dupixent would be the first biologic medicine available in the European Union (EU) to treat these patients.

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  • 9/18/19 7:23 am EDT
    CAMBRIDGE, MA and TARRYTOWN, NY--

    Teenagers face many challenges, and growing up with a chronic skin disease called atopic dermatitis (AD) can impact the ups and downs and transitions to young adulthood. Sanofi and Regeneron, in partnership with the National Eczema Association (NEA), today launched the next phase of Understand AD, a disease awareness initiative focused on educating people about moderate-to-severe AD.

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  • 8/6/19 7:31 am EDT
    PARIS and TARRYTOWN, NY--

    The European Commission (EC) today extended the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent is now the first biologic medicine approved in the EU to treat these patients.

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  • 8/6/19 7:30 am EDT
    PARIS and TARRYTOWN, NY--

    A pivotal Phase 3 trial evaluating Dupixent® (dupilumab) to treat severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints. Dupixent is the first and only biologic to show positive results in this pediatric atopic dermatitis population.

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  • 7/10/19 7:00 am EDT
    Paris--

    The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.

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  • 7/7/19 8:00 am EDT
    Cambridge, MA--

    Positive data from the completed Phase 1/2a EXTEN-A study of BIVV001 (rFVIIIFc-VWF-XTEN) showed a single 65 IU/kg dose of BIVV001 achieved average factor activity levels of 17% at seven days post infusion and significantly extended the half-life of factor VIII to 43 hours. These data were presented today at an oral session of the XXVII Congress of the International Society on Thrombosis and Haemostasis (ISTH 2019) taking place in Melbourne, Australia.

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  • 7/3/19 8:00 am EDT
    Cambridge, MA--

    As recently as five years ago, effectively managing hemophilia meant frequent therapy infusions to prevent uncontrolled bleeding, limitations on physical activities in order to guard against injury and, as adults, chronic and severe pain from accumulated joint damage that, in some cases, led to disability.

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  • 7/1/19 10:02 am EDT
    PARIS and TARRYTOWN, NY--

    The European Commission (EC) has granted conditional marketing authorization for Libtayo® (cemiplimab) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

    Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the only treatment approved in advanced CSCC in the European Union (EU).

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  • 6/28/19 7:02 am EDT
    PARIS and TARRYTOWN, NY--

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab) recommending extending its approval in the European Union (EU) to also include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

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