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FDA Approves Genentech’s Hemlibra for Hemophilia A Without Factor VIII 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, ages newborn and older, with …

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FDA Approves Bayer’s Jivi for the Routine Prophylactic Treatment of Hemophilia A

WHIPPANY, N.J., Aug. 30, 2018 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The initial recommended prophylactic …

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Positive Phase 3 Results for Genentech’s Hemlibra for Hemophilia A without Factor VIII Inhibitors Published in NEJM

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that pivotal data from the Phase III HAVEN 3 study, which evaluated HEMLIBRA® (emicizumab-kxwh) prophylaxis administered every week or every two weeks in adults and adolescents aged 12 years or older with hemophilia …

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Sangamo Announces Positive Preliminary Data from the Phase 1/2 Study Evaluating SB-525 Gene Therapy for Hemophilia A

RICHMOND, Calif., Aug. 8, 2018 /PRNewswire/ — Sangamo Therapeutics, Inc. (Nasdaq: SGMO) today announced positive preliminary data from the Phase 1/2 clinical trial evaluating SB-525, a cDNA gene therapy candidate for Hemophilia A (the “Alta study”). SB-525 is being developed as part of a global collaboration between Sangamo and Pfizer …

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ASH to Collaborate on Clinical Practice Guidelines on Diagnosis and Management of von Willebrand Disease

WASHINGTON, June 21, 2018 /PRNewswire-USNewswire/ — The American Society of Hematology (ASH) will collaborate with the International Society on Thrombosis and Haemostasis (ISTH), National Hemophilia Foundation (NHF), World Federation of Hemophilia (WFH), and the University of Kansas Medical Center to develop clinical practice guidelines on the diagnosis and management of …

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FDA Grants Priority Review to Genentech’s Hemlibra for Patients with Hemophilia A without Factor VIII 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 supplemental Biologics License Application (sBLA) and granted Priority Review for HEMLIBRA® (emicizumab-kxwh) for adults and children with hemophilia A without factor …

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Genentech’s Hemlibra Reduced Treated Bleeds by 96% Compared to No Prophylaxis in Late-Stage Hemophilia Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today full results from the Phase III HAVEN 3 study evaluating HEMLIBRA® (emicizumab-kxwh) prophylaxis administered every week or every two weeks in people with hemophilia A without factor VIII inhibitors and the Phase III …

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FDA Approves Portola’s Andexxa, the First and Only Antidote for the Reversal of Factor Xa Inhibitors

SOUTH SAN FRANCISCO, Calif., May 03, 2018 (GLOBE NEWSWIRE) — Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) has approved Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due …

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FDA Grants Breakthrough Therapy Designation to Genentech’s Hemlibra for Patients with Hemophilia A Without 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 granted Breakthrough Therapy Designation to HEMLIBRA®(emicizumab-kxwh) for people with hemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the …

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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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