Category: Industry News

Joint Statement #5 on Recall of Bayer Kogenate® FS Lots

Bayer announced the recall of two lots of Kogenate®Â 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 […]

Genentech Patient Foundation/Medvantx Announce Ancillary Safety Issue

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 […]

Sigilon Therapeutics Receives Orphan Drug Designation for a Treatment of Hemophilia A

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 […]

Joint Statement #4 on Recall of Bayer Kogenate® FS Lots

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 […]

Joint Statement #3 on Recall of Bayer Kogenate® FS Lots

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 […]

Joint Statement #2 on Recall of Bayer Kogenate® FS Lots

Bayer announced the recall of two lots of Kogenate®Â 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 […]

Joint Statement on Recall of Bayer Kogenate® FS Lots

Last week, Bayer announced the recall of two lots of Kogenate®Â 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 public […]

RECALL NOTICE: Bayer Voluntarily Recalling Factor 8 Product

The following is a press release from Bayer regarding a voluntary recall. PATIENTS SHOULD NOT USE THIS PRODUCT! Bayer is voluntarily recalling two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain […]

Genentech Presents Data for Hemlibra at the ISTH 2019 Congress

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 […]

uniQure Announces Follow-Up Data from Study in Patients with Hemophilia B

The following is an excerpt from a press release from uniQure. Read the press release in its entirety here. uniQure, a gene therapy company advancing transformative therapies for patients with severe medical needs, announced updated clinical data on the three patients treated in the company’s ongoing Phase IIb study of AMT-061, an investigational AAV5-based gene […]