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 an update from Genentech. Read the update in its entirety here. Genentech has provided a statement surrounding an August 27, 2020 US Federal Circuit Court of Appeals ruling which  reverses a previous ruling by the US District Court. In December 2018, the US District Court issued a patent interpretation […]
The following is an excerpt from a statement from Genentech. Read the statement in its entirety here. Genentech has announced an update on measures that are being taken in relation to the translucent particles that were identified in Hemlibra® (emicizumab-kxwh) in 2019 during a routine examination of product batches as part of quality assurance processes. […]
The following is a press release from Genentech. Genentech, a member of the Roche Group announced results from the second interim analysis of the Phase IIIb STASEY study, which reinforce the safety profile of Hemlibra® (emicizumab-kxwh) characterized in the Phase III HAVEN clinical program. In the STASEY study, Hemlibra was effective with no new safety […]
Genentech recently distributed a notice relevant to its product Hemlibra®, reminding health care providers that it is known to interfere with certain laboratory assays used to measure blood coagulation. These tests are often used for patients with bleeding disorders such as hemophilia, and to diagnose and monitor individuals suffering from other conditions that affect coagulation […]
Genentech has issued the following statement regarding the supply and availability of Hemlibra in the wake of the 2019-nCoV (novel coronavirus) outbreak: Please note that HFA does not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, treatments, or opinions. If you have any questions or concerns about your […]
On October 16, 2019, Genentech sent the following letter to HFA and NHF. Genentech’s 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’s statement below, and can read comments on the statement from NHF’s Medical and Scientific Advisory Council (MASAC). The events of the past several months, including today’s announcement by Genentech, underscore the importance of the joint Safety […]
On September 24, 2019, HFA and NHF sent a letter 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 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 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® (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® 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 […]
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