Aptevo Therapeutics Sells IXINITY Hemophilia B Therapy to Medexus Pharmaceuticals
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 Statement on Availability of Factor VIII Products Amid 2019-nCoV (Novel Coronavirus)
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 Statement on Hemlibra Supply Amid 2019-nCoV (Novel Coronavirus)
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 medical […]
Joint Statement on Recall of VONVENDI Lots
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 to […]
Takeda Issues Pharmacy Level Recall of VONVENDI
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 […]
Novo Nordisk launches ESPEROCT® in the U.S. for the treatment of people with hemophilia A
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 […]
BioMarin Announces Gene Therapy Program Updates
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 OverviewBioMarin’s investigational gene therapy valoctocogene roxaparvovec is currently […]
Sangamo and Pfizer Announce Updated Results in Gene Therapy Treatment
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 […]
First Patient Dosed in Phase 3 of Study in Patients with Severe Hemophilia A
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 […]
BioMarin Hemophilia A Clinical Development Program Update
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 of 15 individuals […]
English 
Español de Puerto Rico