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Hemophilia Bleeding Disorder Industry News
Industry News

Spark Therapeutics and Pfizer Announce Longer-term Preliminary Data Showing Consistent and Sustained Factor IX Levels in Hemophilia B

Note: The following is edited from a press release from Spark Therapeutics. Read the full press release in its entirety here. Spark Therapeutics and Pfizer Inc. announced on Dec. 11, 2017, with a cumulative follow-up of more than 13 patient years of observation, all 11 participants in the ongoing Phase 1/2 clinical trial of investigational SPK-9001 for […]

Industry News

Spark Therapeutics Presents Preliminary Data on Investigational SPK-8011 Phase 1/2 Dose-escalation Clinical Trial in Hemophilia A

Note: The following is edited from a press release from Spark Therapeutics. Read the full press release in its entirety here. Spark Therapeutics announced on Dec. 11, 2017, it has dosed seven participants in the Phase 1/2 clinical trial of SPK-8011 in hemophilia A. The first four participants, who have been followed at least 12 weeks post […]

Industry News

Bioverativ Announces Results of Eloctate Study Showing High Bleed Protection and Target Joint Resolution

Note: The following is edited from a press release from Bioverativ. Read the full press release in its entirety here. Bioverativ Inc. and Swedish Orphan Biovitrum AB announced the results of a new, post-hoc, longitudinal analysis of the pivotal Phase 3 A-LONG study and ASPIRE long-term extension study, showing that weekly prophylactic dosing with its […]

Industry News

Bioverativ Announces Findings From Novel Imaging Study Using Alprolix

Note: The following is edited from a press release from Bioverativ. Read the full press release in its entirety here. Bioverativ Inc., a global biopharmaceutical company dedicated to transforming the lives of people with rare blood disorders, today announced findings from a novel imaging study investigating extravascular distribution of factor IX therapies, including its leading extended […]

Industry News

FDA Lifts Clinical Hold on Fitusiran

Note: The following is edited from a press release from Alnylam Pharmaceuticals. Read the full press release in its entirety here. Alnylam Pharmaceuticals Inc., a RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced Dec. 15, 2017, the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, including […]

Industry News

Genentech Presents New Data on Hemlibra at ASH 2017

Note: The following is edited from a press release from Genentech. Read the full press release in its entirety here. Genentech, a member of the Roche Group, announced on Dec. 9, 2017, new data from the ongoing HEMLIBRA® (emicizumab-kxwh) clinical development program were presented at the 59th American Society of Hematology (ASH) Annual Meeting. These data […]

Industry News

Shire Files Preliminary Injunction Against Genentech/Roche

Note: The following is edited from a press release from Shire. Read the full press release in its entirety here. On December 14, 2017, Shire filed a motion for preliminary injunction against Roche subsidiaries Genentech Inc. and Chugai Pharmaceutical Co., Ltd., as part of an ongoing U.S. patent infringement lawsuit surrounding Genentech/Roche’s emicizumab, currently being marketed as […]

Industry News

Genentech Announces Interim Result from Phase III HAVEN 4 Study

Note: The following is an edited excerpt from a press release from Genentech. To read the press release in it’s entirety, click HERE. Genentech, a member of the Roche Group, 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 […]

Industry News

Genentech Releases Phase III HAVEN 3 Results

The following is an edited excerpt from a press release from Genentech. To read the press release in full, click here. Genentech, a member of the Roche Group, announced positive results from the Phase III HAVEN 3 study evaluating Hemlibra (emicizumab-kxwh) in adults and adolescents (aged 12 years or older) with hemophilia A without inhibitors to […]

Industry News

FDA Approves Genentech’s HEMLIBRA, (Emicizumab-KXWH) for Hemophilia A with Inhibitors

Note: The following is an edited excerpt from a press release from Genentech. To read the press release in it’s entirety, click HERE. Genentech, a member of the Roche Group, 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 […]

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