• 4/17/19 7:59 am EDT
    Cambridge, MA--

    On World Hemophilia Day April 17th, the global bleeding disorders community unites to raise awareness and understanding of hemophilia and areas of unmet needs for patients. Hemophilia is a rare, genetic bleeding disorder in which the ability of a person’s blood to clot is impaired, which can lead to bleeding episodes that can cause pain, irreversible joint damage, and life-threatening hemorrhages. Hemophilia most often occurs in boys, and there is currently no cure.

    Hemophilia: A Global Public Health Challenge

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  • 4/8/19 7:58 am EDT
    Paris--

    Sanofi and Alnylam have agreed to conclude the research and option phase of the companies’ 2014 RNAi therapeutics alliance in rare genetic diseases. The material collaboration terms for patisiran, vutrisiran (ALN-TTRsc02) and fitusiran, as previously  announced, will continue unchanged.

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  • 3/14/19 10:43 am EDT
    Cambridge, MA--

    Sanofi Genzyme, the specialty care business unit of Sanofi, today announced the launch of a first-of-its-kind audio adventure series designed to provide an engaging and educational infusion experience for ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] patients and their caregivers. Sanofi Genzyme will debut Infusion Squad at The Coalition for Hemophilia B’s Annual Symposium in Orlando, Florida, from March 14 -17 in booth #19.

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  • 3/11/19 3:48 pm EDT
    CAMBRIDGE, MA and TARRYTOWN, NY--

    The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

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  • 3/8/19 7:36 am EST
    PARIS and TARRYTOWN, NY--

    The  U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). Patients with severe CRSwNP often experience recurrence despite previous treatment with surgery and/or systemic corticosteroids. The target action date for the FDA decision is June 26, 2019.

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  • 3/1/19 8:19 am EST
    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 its approval in the European Union for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.

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  • 3/1/19 7:02 am EST
    CAMBRIDGE, MA and TARRYTOWN, NY--

    A diverse set of clinical and real-world data will be presented at the 2019 American Academy of Dermatology (AAD) Annual Meeting from March 1 to 5 in Washington, D.C.

    “The data presented at AAD 2019 build upon the established body of knowledge around the efficacy and safety of Dupixent, which has been used to treat nearly 50,000 patients with inadequately controlled moderate-to-severe atopic dermatitis since its approval nearly two years ago,” said Neil Graham, M.D., Vice President of Program Direction at Regeneron.

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  • 2/25/19 12:46 pm EST
    PARIS and TARRYTOWN, NY--

    Detailed results were presented from two Phase 3 trials in adults with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) despite previous treatment with surgery and/or systemic corticosteroids. These trials, known as SINUS-24 and SINUS-52, demonstrated that Dupixent® (dupilumab), when added to the standard of care corticosteroid nasal spray,  improved nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell and co-morbid asthma outcomes.

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  • 2/7/19 9:46 am EST
    Cambridge, MA--

    Results from multiple studies of the investigational therapy avalglucosidase alfa in patients with Pompe disease were presented this week during the 15th Annual WORLDSymposium™ in Orlando, Florida. Pompe disease is a progressive, debilitating and often fatal neuromuscular disease that affects an estimated 50,000 people worldwide.  It can occur at any age from infancy to late adulthood.

    NEO-EXT: Ongoing extension study of the Phase 1/2 trial

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  • 2/6/19 12:12 pm EST
    Paris--

    The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.  Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP.

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