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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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  • 6/26/19 1:34 pm EDT
    PARIS and TARRYTOWN, NY--

    The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. CRSwNP can be a debilitating condition, with many patients opting for systemic steroids or nasal surgery which often cannot control this disease. Moreover, CRSwNP often occurs in combination with severe asthma.

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  • 6/24/19 8:50 am EDT
    Cambridge, MA--

     New investigational data for Sanofi’s approved and hemophilia pipeline therapies will be presented at the XXVII Congress of the International Society on Thrombosis and Haemostasis (ISTH 2019) taking place July 6-10, 2019 in Melbourne, Australia.

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  • 6/21/19 7:00 am EDT
    PARIS and TARRYTOWN, NY--

    Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that a Phase 2 proof-of-concept trial evaluating the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. The trial also met a key secondary endpoint, demonstrating REGN3500 monotherapy significantly improved lung function compared to placebo. 

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  • 6/2/19 10:46 am EDT
    Paris--

    Pivotal Phase 3 ICARIA-MM trial results demonstrated that isatuximab added to pomalidomide and dexamethasone (isatuximab combination therapy) showed statistically significant improvements compared to pomalidomide and dexamethasone (pom-dex) alone in patients with relapsed/refractory multiple myeloma (RRMM).

    These findings were presented today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.

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  • 5/16/19 8:42 am EDT
    CAMBRIDGE, MA and TARRYTOWN, NY--

    Sanofi and Regeneron Pharmaceuticals, Inc. today announced that positive updated data for Libtayo® (cemiplimab-rwlc) in locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC) will be shared at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago.

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