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Hemophilia

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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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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