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Sanofi to Acquire Hemophilia Company Bioverativ for $11.6 Billion

Paris (France) and Waltham, Mass. – January 22, 2018 – Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 per share in cash, representing …

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FDA Lifts Clinical Hold on Alnylam’s Hemophilia Drug Candidate Fitusiran

CAMBRIDGE, Mass. & PARIS–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, including the Phase 2 open-label extension (OLE) study …

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Genentech’s Hemlibra Every Four Weeks Controlled Bleeds in Late-Stage Hemophilia A Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive interim results from the Phase III HAVEN 4 study evaluating HEMLIBRA® (emicizumab-kxwh) prophylaxis dosed once every four weeks in adults and adolescents (12 years of age or older) with hemophilia A with …

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FDA Updates Label for Alprolix, Adding Long-Term Safety and Efficacy Data

WALTHAM, Mass.–(BUSINESS WIRE)–Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical company dedicated to transforming the lives of people with rare blood disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the leading extended half-life therapy for the …

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Genentech’s Hemlibra Receives FDA Approval for Treatment of Hemophilia A with Inhibitors

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved HEMLIBRA® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor …

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Interim Data of Prophylactic Eloctate Shows Improvements in Long-Term Joint Health for Hemophilia A Patients

WALTHAM, Mass. & STOCKHOLM–(BUSINESS WIRE)–Bioverativ Inc. (NASDAQ: BIVV) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced the publication of interim results from a longitudinal study of joint health in patients treated prophylactically with ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], marketed as Elocta® in Europe and the Middle East, for treatment …

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FDA Accepts Bayer’s Biologics License Application for BAY94-9027 for Treatment of Hemophilia A

WHIPPANY, N.J., Oct. 30, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has accepted Bayer’s Biologics License Application (BLA) filing for BAY94-9027, an extended half-life site-specifically PEGylated recombinant human Factor VIII compound, for the treatment of hemophilia A in adults and adolescents 12 years of age and over. …

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Biomarin’s Gene Therapy Granted FDA Breakthrough Therapy Designation for the Treatment of Hemophilia A

SAN RAFAEL, Calif., Oct. 26, 2017 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the U.S. Food and Drug Administration (FDA) granted valoctocogene roxaparvovec (formerly BMN 270) Breakthrough Therapy Designation. The FDA’s Breakthrough Therapy Designation program is intended to facilitate and expedite development and review of new drugs …

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Patient Death Forces Alnylam to Suspend Dosing in All Ongoing Fitusiran Studies in Hemophilia Patients

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY), the leading RNAi therapeutics company, announced today an update on the company’s fitusiran and givosiran investigational RNAi therapeutic programs. With fitusiran, an RNAi therapeutic in development for the treatment of hemophilia A and B with or without inhibitors, Alnylam is reporting a fatal thrombotic …

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Genentech’s Emicizumab Receives Priority Review from the FDA for Treatment of Hemophilia A with Inhibitors

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents …

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