Hemophilia Federation of America is a national nonprofit organization that assists, educates, and advocates for the bleeding disorders community.
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® prophylaxis in children younger than 12 years of age with hemophilia A with factor […]
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® prophylaxis in children younger than 12 years of age with hemophilia A with factor VIII […]
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 […]
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: 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 […]
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® prophylaxis administered every week or every two weeks in adults and adolescents aged 12 years or […]
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 the U.S. Food and Drug Administration has accepted the company’s supplemental Biologics License Application and granted Priority Review for HEMLIBRA for adults and children with hemophilia A without factor VIII […]
The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) has released a safety information update about Emicizumab (Hemlibra), a new subcutaneous treatment for hemophilia A patients with inhibitors. This update has been released following the first report of an anti-drug antibody to Emicizumab. MASAC’s update issues recommendations for providers and patients in case of […]
The following is an excerpt from a statement from Genentech. Read the entire statement HERE. _________________________________________________________ Genentech has recently learned that a patient in the Phase III HAVEN 2 clinical trial developed a neutralizing anti-drug antibody. For this patient, the anti-drug antibody resulted in reduced efficacy of HEMLIBRA.
The following is an excerpt from a press release from Genentech. Read the full press release here. Genentech, a member of the Roche Group, announced today the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to HEMLIBRA for people with hemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the […]
Note: The following is an excerpt from a press release from Genentech. Read the full press release here. ______________________________________________________________________________________ Given the recent dialogue, we are reaching out to clarify the facts surrounding five people with hemophilia A with inhibitors to factor VIII who have passed away while receiving Hemlibra® (emicizumab-kxwh). Since 2016, five adults with hemophilia A […]
HFA was informed by Genentech on March 26, 2018, that a total of five patient deaths have occurred while the patients were using Hemlibra (emicizumab-kxwh). Genentech has little information that they can presently share about the circumstances surrounding the most recent patient deaths; however, Genentech could confirm that the patients had received Hemlibra as part of compassionate use and expanded patient access. Genentech has a Medical Communications line at 1(800)-821-8590 for patients, concerned community members, and healthcare providers who seek further information. […]
Shire has published a statement regarding the ongoing lawsuit Shire has filed against Genentech/Roche. Read the full statement in its entirety here.
In the past few weeks, we have received many inquiries regarding the scope of the injunction Shire is seeking in its lawsuit against Genentech/Roche. Certain information has become public during this period that enables NHF and HFA to provide some limited guidance as to the scope of the injunction that Shire has requested from the […]
Genentech has published a statement regarding patient access to Hemlibra (Emicizumab-kkwh). Read the full statement in its entirety here.
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 […]
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 […]
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 […]
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 […]
Note: The following is an edited version of a press release from Genentech. Read the press release from Genentech in it’s entirety here. Genentech, a member of the Roche Group, 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 […]
Note: The following is an excerpt from a Reuters news article. Read the article in full here. Pharmaceutical group Shire said on Sunday it had obtained a preliminary injunction in a Hamburg court against rival Roche over its hemophilia drug emicizumab, alleging incomplete and misleading statements surrounding the treatment. Roche said in an emailed statement it […]
The New England Journal of Medicine has published two articles and an editioral in conjunction with the International Society of Thrombosis and Haemostasis meeting being held in Berlin, Germany, July 8-13, 2017. The articles include information on novel hemophilia treatment products currently in clinical trial. Click on the links below to read the articles in […]
Note: The following is an edited version of a press release from Genentech. Read the press release from Genentech in it’s entirety here. Genentech, a member of the Roche Group, announced today that data from HAVEN 1, a Phase III study evaluating once-weekly subcutaneous emicizumab prophylaxis (preventative) in adults and adolescents with hemophilia A with inhibitors, were published […]
Genentech, a member of the Roche Group announced today positive data from the primary analysis of the Phase III HAVEN 1 study in adults and adolescents and interim analysis of the Phase III HAVEN 2 study in children evaluating once-weekly subcutaneous emicizumab prophylaxis (preventative) for the treatment of hemophilia A with inhibitors to factor VIII. […]
On April 16, 2017 Genentech announced interim results from the Phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with hemophilia A and inhibitors to factor VIII. According to this Genentech’s press releases, “interim analysis after a median of 12 weeks of treatment, emicizumab prophylaxis showed a clinically meaningful reduction in the […]
The following is the full statement from Genentech/Roche regarding the recent death of a 41-year-old hemophilia with inhibitors patient who was participating in the HAVEN 1 study. Dear members of the Haemophilia community, At Roche, we respect and value the close relationships that exist within the haemophilia community. We also understand the important role patient […]
______________________________________________________________________________ Note: The following is edited from a press release from Genentech. Read the full press release in it’s entirety here. Genentech, a member of the Roche Group, announced that the primary endpoint has been met for the Phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 years of age or older with hemophilia […]
Note: The below is an edited version of an article originally published on BusinessWire. The original article can be read in their entirety here. The latest data from an ongoing Japanese Phase I/II study of Emicizumab were presented earlier this week at the World Federation of Hemophilia 2016 World Congress. Emicizumab (a product being developed by […]
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