Genentech's Hemlibra Provided Sustained Bleed Control in the Largest Pivotal Study in Children with Hemophilia A with Inhibitors
The following is an excerpt from a press release from Genentech. Read the press release in its entirety here. Genentech, a member of the Roche Group, announced data from the primary analysis of the Phase III HAVEN 2 study evaluating Hemlibra®Â prophylaxis in children younger than 12 years of age with hemophilia A with factor VIII […]
Bioverativ Data Presented at ASH Underscore Potential for Once Weekly Dosing with Sustained High Factor Levels in Hemophilia A
The following is an excerpt from a press release from Bioverativ. Read the press release in its entirety here. Bioverativ Inc., a Sanofi company dedicated to transforming the lives of people with rare blood disorders, presented new data from the EXTEN-A Phase 1/2a trial of BIVV001 showing that a single 65 IU/kg dose of BIVV001 extended […]
uniQure Announces Long-Term Clinical Data from Ongoing Phases and Confirms Dose for Hemophilia B Study
The following is an excerpt from a press release from uniQure. Read the press release in its entirety here. uniQure N.V., a gene therapy company advancing transformative therapies for patients with severe medical needs, announced updated results from its ongoing Phase I/II trial of AMT-060, and provided an update on AMT-061, the company’s next-generation gene therapy candidate […]
Update on uniQure's Hemophilia B Gene Therapy Program
The following is an excerpt from a press release from uniQure. Read the press release in its entirety here. uniQure announces the initial topline data from our Phase 2B dose-confirmation study of AMT-061, an investigational gene therapy for the treatment of patients with severe and moderately severe hemophilia B. All patients achieved and sustained therapeutic […]
uniQure Highlights Pipeline Expansion and Advancements in Technology at Research and Development Day
The following is a press release from uniQure. uniQure, a gene therapy company advancing transformative therapies for patients with severe medical needs, announced the expansion of its research pipeline with novel AAV gene therapy approaches to treating Hemophilia A, Fabry disease and Spinocerebellar Ataxia Type 3 at the Company’s Research & Development Day held this […]
Genentech to Present New Data at the American Society of Hematology 2018 Annual Meeting
The following is an excerpt from a press release from Genentech. Read the press release in its entirety here. Genentech has announced new data that will be presented at this year’s annual American Society of Hematology meeting held in San Diego from Dec. 1-4. Ten Genentech medicines will be featured in more than 70 abstracts, including 25 […]
FDA Approves Genentech's Hemlibra
The following is an excerpt from a press release from Genentech. Read the entire press release here. Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration 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, […]
Genentech Announces the Launch of New Safety Website
Genentech has announced a new web portal for patients and caregivers intended to provide timely and accurate information on targeted serious adverse events of interest for HEMLIBRA. Visit the safety website:Â http://www.emipatientinfo.com/.Earlier this year, Genentech launched a similar site specifically for health care providers.In announcing the launch, Genentech stated “This website is meant to serve as […]
Phase III Results for Genentech's Hemlibra Published in New England Journal of Medicine
The following is an excerpt from a press release from Genentech. Read the press release in its entirety here. Genentech, a member of the Roche Group, announced that pivotal data from the Phase III HAVEN 3 study, which evaluated HEMLIBRA®Â prophylaxis administered every week or every two weeks in adults and adolescents aged 12 years or […]
Bayer Receives FDA Approval for Jivi, New Hemophilia A Treatment With Step-Wise Prophylaxis Dosing Regimen
The following is an excerpt from a press release from Bayer. Read the press release in its entirety here. Bayer announced that the U.S. Food and Drug Administration has approved Jivi® for the routine prophylactic treatment of hemophilia A in previously-treated adults and adolescents 12 years of age or older. The initial recommended prophylactic regimen […]