Hemophilia Federation of America is a national nonprofit organization that assists, educates and advocates for the bleeding disorders community.
The following is information shared with the bleeding disorders community by Takeda. “Takeda has been closely monitoring the news surrounding COVID-19. Our highest priority is the health and safety of our community during this uncertain time. We are taking steps to help ensure the community’s safety including postponing upcoming educational events such as our HELLO […]
The following is information shared by Pfizer Inc. “To avoid adding to the demands on the healthcare system during this unprecedented crisis with COVID-19, we are pausing for three weeks the recruitment portion of our new and ongoing global interventional clinical studies. We are taking this action in the interests of public health, so that […]
The following is a press release from uniQure. uniQure N.V., a leading gene therapy company advancing transformative therapies for patients with severe unmet medical needs, announced it has achieved the targeted dosing of patients in the HOPE-B pivotal trial of etranacogene dezaparvovec (AMT-061), an investigational AAV5-based gene therapy incorporating the patent-protected FIX-Padua variant for the […]
The following is a letter provided by Spark Therapeutics. “In the unprecedented time of the COVID-19 (novel coronavirus) pandemic, Spark Therapeutics has closely monitored this evolving situation and taken steps to protect the well-being and safety of both our workforce and the patients and families we serve. In reference to our ongoing gene therapy clinical […]
The following is a letter provided by Octapharma. “As we all manage the challenges presented by the Coronavirus pandemic, Octapharma USA would like to remind you of our commitment to providing our customers life-saving therapies, manufactured to the highest standards of viral clearance and safety. Our staff continues to focus on maintaining production of all […]
Ver esta página en español STATEMENTS AND UPDATES During this time of rapidly-changing news surrounding the COVID-19 outbreak, HFA will continue to publish updates and information about COVID-19 and its effects on the bleeding disorders community. MEDICAL NEWS INDUSTRY NEWS & PRODUCT AVAILABILITY NATIONAL, GOVERNMENT AND LOCAL NEWS RESOURCES FAQ: BLEEDING DISORDERS AND COVID-19 HFA […]
The following is a press release from Genentech. “The World Health Organization has declared the COVID-19 (coronavirus) outbreak a global pandemic. We extend our heartfelt sympathies to everyone who has lost loved ones, to patients and healthcare professionals battling this devastating outbreak. With multiple countries implementing measures to slow the spread of the virus, based […]
The following is a press release from Pfizer. Pfizer Confirms BeneFIX® and XYNTHA® Remain Available Pfizer recognizes the public concern in relation to the COVID-19 pandemic, which continues to evolve. We are actively monitoring the situation across the globe, assessing the implications to our patients, colleagues and company, and taking actions to support continued health […]
The following is a letter from Takeda.  “To the bleeding disorders community, As a global pharmaceutical leader, our top priority during the ongoing COVID-19 outbreak is to do all we can to make sure our medicines and services continue to reach the individuals who rely on them, while we protect the health of our employees, […]
The following is information provided by Pfizer and BioNTech. On March 13, 2020, Pfizer issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to collaboration to combat COVID-19. Â Pfizer Inc. and BioNTech announced that the companies have agreed to a letter of intent regarding the co-development and distribution (excluding […]
The following is information provided by IXINITY. Read the full statement here. “The health and safety of individuals who rely on our products, their caregivers and community members, healthcare professionals, and our own team is of upmost importance to Medexus Pharma, the company behind IXINITY. We want to reassure the community that we currently do […]
The following is a statement provided by Grifols. “As the situation with the novel coronavirus rapidly evolves, we wanted to inform you that Grifols is taking measures in line with recommendations from the World Health Organization (WHO) to help ensure the safety of our employees, donors, products, and the patient communities we serve. We have […]
The following is an excerpt from a press release published by Novo Nordisk. Novo Nordisk announced that two clinical trials in the concizumab phase 3 programme (explorer7 and 8) and one clinical trial in the phase 2 programme (explorer5) have been paused. The three clinical trials were investigating concizumab prophylaxis treatment in haemophilia A and […]
The following is a response provided by Sanofi. “At Sanofi, we have a simple purpose – to discover breakthrough medicines and vaccines to improve the lives of millions of people around the world. This drive to transform the practice of medicine has taken on increased urgency for everyone in the Sanofi family since the emergence […]
The following is a letter provided by Novo Nordisk.  “You’ve come to know us as a part of the fabric of the hemophilia community for more than 30 years, always working to make things better for everyone affected by rare bleeding disorders. We know this is a challenging time for all as with the World […]
CSL Behring has added a statement to their website regarding the measures the company is taking in the wake of the 2019-nCoV (novel coronavirus) outbreak.
As previously reported by HFA and NHF, Takeda announced the recall of two lots of VONVENDI von Willebrand factor (recombinant) 1,300 I.U. vials on Feb. 25, 2020. HFA and NHF recognize that recalls can be very unsettling for many in the bleeding disorders community. On Feb. 27, 2020, the patient organizations announced they had submitted a […]
The following is an excerpt from a press release from Aptevo Therapeutics. Read the press release in its entirety here. Aptevo Therapeutics Inc. , a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ bispecific technology platform, announced it has completed the sale of its marketed recombinant factor IX therapeutic, IXINITY® […]
Bayer has issued the following statement regarding the supply and availability of Bayer’s Factor VIII/Hemophilia A products in the wake of the 2019-nCoV (novel coronavirus) outbreak:
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 […]
Takeda announced the recall of two lots of VONVENDI vonWillebrand factor (recombinant) 1,300 I.U. vials on February 25, 2020. HFA and NHF recognize that recalls can be very unsettling for many in the bleeding disorders community. We are in communications with Takeda to obtain additional detailed and timely information regarding the events that led up […]
Late yesterday (February 25, 2020), Takeda announced a pharmacy-level recall of two lots of VONVENDI von Willebrand factor (recombinant) 1,300 IU vials. Takeda’s announcement stated that “Although both lots met all acceptance criteria, Takeda is issuing a voluntary recall out of an abundance of caution. Takeda believes that despite this voluntary recall that [sic] there […]
The following is an excerpt from a press release from Novo Nordisk. Read the press release in its entirety here. Novo Nordisk announced ESPEROCT® [antihemophilic factor (recombinant), glycopegylated-exei] is now available in the U.S. for the treatment of adults and children with hemophilia A. ESPEROCT® is a recombinant extended half-life factor VIII replacement therapy used to prevent […]
The following is an announcement from BioMarin. BioMarin announced an update to the community regarding our ongoing gene therapy clinical trial program in hemophilia A. BioMarin’s investigational gene therapy for hemophilia A has not been approved for use; it is in ongoing clinical trials evaluating its safety and efficacy. Clinical Trial Overview BioMarin’s investigational gene therapy valoctocogene roxaparvovec […]
The following is an excerpt from a press release from Sangamo. Read the press release in its entirety here. Sangamo Therapeutics Inc., a genomic medicine company, and Pfizer Inc. announced updated follow-up results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy in patients with severe hemophilia A. The data showed that SB-525 […]
The following is an excerpt from a press release from Sanofi Genzyme. Read the press release in its entirety here. Sanofi and SobiTMÂ announced the first patient has been dosed in the Phase 3, open-label, interventional study of BIVV001 (rFVIIIFc-VWF-XTEN), in patients with severe hemophilia A (XTEND-1 study; NCT04161495). Sobi and Sanofi are development partners for […]
The following is a press release from BioMarin.  BioMarin is pleased to update the community regarding our gene therapy clinical trial program in hemophilia A. Clinical Trial Update BioMarin’s investigational gene therapy valoctocogene roxaparvovec, is currently being studied in adults with severe hemophilia A. The first Phase 1/2 study was initiated in 2015 and consists […]
The following is an excerpt from a press release from Sangamo. Read the press release in its entirety here. Sangamo Therapeutics Inc., a genomic medicine company, announced that hemophilia A gene therapy clinical data and hemoglobinopathies ex vivo gene-edited cell therapy data will be featured in poster presentations at the 61st Annual Meeting of the […]
The following is a press release from Sigilon Therapeutics. Sigilon Therapeutics announced it will present data at the American Society of Hematology Annual Meeting demonstrating that its novel Shielded Living TherapeuticsTM platform for rare bleeding disorders remains viable in animal models for at least six months. The data also demonstrate dose-responsive in vivoexpression of human coagulation […]
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 […]
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