Hemophilia Federation of America is a national nonprofit organization that assists, educates and advocates for the bleeding disorders community.
On October 16, 2019, Genentech sent the following letter to HFA and NHF. Genentech鈥檚 letter responds to questions posed in the joint HFA-NHF letter of October 11, regarding reports of particulate matter in vials of Hemlibra. HFA and NHF will keep the bleeding disorders community informed as further information develops. Please note that HFA and […]
Today, Genentech provided the following statement regarding reports of particulate matter in vials of Hemlibra. You can read Genentech鈥檚 statement below, and can read comments on the statement from NHF鈥檚 Medical and Scientific Advisory Council (MASAC). The events of the past several months, including today鈥檚 announcement by Genentech, underscore the importance of the joint Safety […]
On September 24, 2019, HFA and NHF sent a聽letter聽to Genentech and MedVantx regarding the shipment of incorrect length injection needles to patients who receive Hemlibra through the Genentech Patient Foundation. The Genentech Patient Foundation responded to our inquiries by letter dated September 25, 2019. You can read their response聽here. HFA and NHF will update the […]
Late in the day on Friday, September 20, 2019, Genentech informed HFA and NHF that a contracted specialty pharmacy, Medvantx, had shipped incorrect length injection needles to patients who receive Hemlibra through the Genentech Patient Foundation. HFA and NHF posted that notice on September 21st. Today we followed up with a letter to Genentech and […]
HFA has received the聽following notice from Genentech regarding the shipment of incorrect length injection needles to patients who receive Hemlibra through the Genentech Patient Foundation: “We were recently informed that ancillary supplies shipped by a specialty pharmacy, Medvantx, to a specific group of patients receiving Hemlibra through the Genentech Patient Foundation contained incorrect length injection […]
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 today new data for Hemlibra庐 (emicizumab-kxwh) across multiple pivotal studies in people with hemophilia A with and without factor VIII inhibitors at the International Society on Thrombosis and […]
The following is an excerpt from a press release from Spark Therapeutics. Read the press release in its entirety here. Spark Therapeutics , a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, announced today that it has entered into a definitive merger agreement for Roche to fully acquire Spark […]
The following is a press release from Roche. Read the press release in its entirety here. Roche announced it has joined the World Federation of Hemophilia Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment for people with inherited bleeding disorders in developing countries. Together […]
The following is an excerpt from a press release from Roche. Read it in its entirety here. Roche today announced that it has joined the World Federation of Hemophilia Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment for people with inherited bleeding disorders in […]
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庐 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庐聽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聽Genentech聽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:聽http://www.emipatientinfo.com/. Earlier this year, Genentech launched a similar site specifically for health care providers. In announcing the launch, Genentech stated 鈥淭his website is meant to […]
The following is an excerpt from a press release from Genentech. Read the press release in its entirety here.聽 Genentech, a member of the Roche Group, announced that pivotal data from the Phase III HAVEN 3 study, which evaluated HEMLIBRA庐聽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鈥檚 supplemental Biologics License Application and granted Priority Review for HEMLIBRA 聽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鈥檚 update issues recommendations for providers and patients in case of […]
The following is an excerpt from a statement from Genentech. Read the entire statement 聽HERE. _________________________________________________________ Genentech has recently learned that a patient in the Phase III HAVEN 2 clinical trial developed a neutralizing anti-drug聽antibody. For聽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.聽 Genentech, a member of the Roche Group, announced today the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to HEMLIBRA聽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聽hemophilia A with inhibitors to factor VIII who have passed away while receiving Hemlibra庐聽(emicizumab-kxwh). Since 2016, five adults with hemophilia A […]
HFA was informed by Genentech on March 26, 2018,聽that聽a聽total of five聽patient deaths have聽occurred聽while聽the patients were聽using聽Hemlibra聽(emicizumab-kxwh).聽Genentech has little information that they can presently share聽about the circumstances聽surrounding the聽most recent聽patient聽deaths; however, Genentech could confirm that the patients聽had received聽Hemlibra聽as part of聽compassionate use and聽expanded patient access. Genentech has a聽Medical Communications line聽at聽1(800)-821-8590聽for patients, concerned community members, and healthcare providers聽who聽seek further information. […]
Shire has published a聽statement regarding the ongoing lawsuit Shire has filed against Genentech/Roche. Read the full statement聽in its entirety聽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.聽 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聽statement regarding patient access to Hemlibra (Emicizumab-kkwh). Read the full statement聽in its entirety聽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庐聽(emicizumab-kxwh) clinical development program were presented at the 59th American Society of Hematology (ASH) Annual Meeting. These data […]
Note:聽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聽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聽(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庐聽(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.聽Read the press release from Genentech聽in it鈥檚 entirety here. Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company鈥檚 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聽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 […]
Sign up for E-mails, Dateline Magazine, and other ways to stay connected.
CONTACT HFA
999 N Capitol Street NE Suite 201
Washington, D.C. 20002
Phone: 202.675.6984
Toll Free:
Fax: 202.675.6983
Email: info@hemophiliafed.org
HELPFUL LINKS
FOLLOW HFA
CERTIFICATIONS
