Hemophilia Federation of America is a national nonprofit organization that assists, educates and advocates for the bleeding disorders community.
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 […]
CSL Behring has advised HFA and NHF of a printing misalignment on the label of its Humate P product for von Willebrand disease. You can read CSL Behring’s statement, and see images of the product box, below. While the current Humate P notification is prompted by a printing error on the outside of the box, NHF […]
Hemophilia Federation of America and National Hemophilia Foundation continue to follow up on issues arising from Genentech’s recent announcement regarding reports of particulate matter in vials of Hemlibra. You can read comments on the statement from NHF’s Medical and Scientific Advisory Council (MASAC). Today HFA and NHF sent Genentech a letter with additional questions, which you […]
The following is a press release from Octapharma. Read the press release in its entirety here. Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control […]
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 […]
HFA and NHF are pleased to share a brief update with the community concerning a recent meeting we had with the FDA as well as a number of additional resources that the FDA provided after the call. HFA and NHF will continue to update the bleeding disorders community as any further information develops. Please note […]
On Sept. 27, 2019, Bayer sent the following letter and pharmacovigilance summary to HFA and NHF. Bayer submitted these materials in response to a joint HFA-NHF letter, part of the ongoing dialog over Bayer’s distribution and subsequent recall of two lots of improperly labeled, expired clotting factor. Please note that NHF and HFA do not recommend, endorse […]
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 […]
Bayer announced the recall of two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 I.U. vials on July 19, 2019. Bayer announced that 3000 I.U. of one product (Jivi), past its expiration date, had been mislabeled as another product (2000 I.U. of Kogenate FS) and distributed to the public for six months. This is a deeply […]
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 a press release from Sigilon Therapeutics. Read the press release on the Sigilon website here. Sigilon Therapeutics has announced it has received Orphan Drug Designation for SIG-001, an investigational therapy for hemophilia A that leverages Sigilon’s Shielded Living Therapeutics™Â platform to implant cells engineered to produce stable blood plasma levels of factor VIII, a crucial […]
Hemophilia Federation of America and National Hemophilia Foundation continue to follow up on issues arising from Bayer’s distribution of mislabeled, expired clotting factor and subsequent recall of that product. The most recent set of joint HFA-NHF inquiries to Bayer focused on the short- and long-term medical consequences for affected patients. Bayer today released this response […]
We recognize the recent recall from Bayer has caused deep concern and has been unsettling for many in the bleeding disorders community. As part of our ongoing discussion with Bayer, Hemophilia Federation of America and National Hemophilia Foundation have received the following letter and update regarding the recall of Kogenate FS. This letter includes Bayer’s […]
Bayer announced the recall of two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 I.U. vials on July 19, 2019. Bayer announced that 3000 I.U. of one product (Jivi), past its expiration date, had been mislabeled as another product (2000 I.U. of Kogenate FS) and distributed to the public for six months. This is a deeply […]
Last week, Bayer announced the recall of two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials.That highly concerning announcement has raised many questions on the part of both national organizations and community members. The fact that one product (Jivi), past its expiration date, was mislabeled as another product (Kogenate FS) and distributed to the […]
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