Category: Industry News

Sangamo to Announce Gene Therapy and Ex Vivo Gene-Edited Cell Therapy Data at ASH

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 […]

Sigilon Therapeutics to Present Preclinical Data on Rare Blood Disorders at ASH

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 […]

Genentech Response to HFA-NHF Letter Regarding Particulate Matter in Hemlibra

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 NHF […]

CSL Behring Announces Printing Misalignment for Humate-P

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 and […]

Joint Letter from HFA-NHF to Genentech Regarding Particulate Matter in Hemlibra

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 […]

FDA Approves Octapharma’s Wilate for Hemophilia A in Adult and Adolescent Patients

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 […]

Genentech Issues Statement on Hemlibra Particles; MASAC Responds

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 Summit […]

Bayer Responds to HFA-NHF Letter

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 or […]

Genentech Patient Foundation Responds to HFA-NHF Letter

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 bleeding […]

Joint Statement #1 on Genentech Patient Foundation/Medvantx Needle Error

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 […]