Biotech Business - May 13, 2022
Hansa Biopharma announces temporary marketing authorization in Switzerland
Hansa Biopharma has announces that the Swiss Agency for Therapeutic Products (Swissmedic) has granted temporary marketing authorization for Idefirix in adult patients with a positive crossmatch against an available organ from a diseased donor. The use of Idefirix in Switzerland is reserved for patients with a low probability of being transplanted within the framework of […]
Biotech Business - August 2, 2021
Hansa Biopharma announces reimbursement in the Netherlands of Idefirix
Hansa Biopharma has announced that its treatment Idefirix is, as of August 1, reimbursable and available for use in the Netherlands. Idefirix is the first and only treatment approved for use in the European Union for desensitization of highly sensitized patients prior to kidney transplantation, allowing them to be considered for a life-altering kidney transplantation […]
Agreement - April 14, 2021
Hansa Biopharma collaborates with argenx
The companies have entered into a preclinical research collaboration agreement to evaluate the therapeutic potential of combining their two IgG-modulating technologies. The preclinical research collaboration is set up to explore the potential of combining imlifidase, Hansa’s IgG antibody-cleaving enzyme, and efgartigimod, argenx’s FcRn antagonist, which are both in development for indications known to be driven […]
Clinical Trials - October 29, 2020
Hansa Biopharma announces new data
Hansa Biopharma has announced positive data from an investigator-initiated phase 2 trial that evaluated safety, tolerability and efficacy of imlifidase in 15 patients with severe anti-GBM antibody disease. Anti-GBM antibody disease, also known as Goodpasture’s disease, is a severe autoimmune disease where the immune system mistakenly develops IgG-antibodies directed against the glomerular basement membrane (GBM), […]
Biotech Business - August 27, 2020
Hansa Biopharma’s Idefirix granted conditional approval in EU
Hansa Biopharma has announced that the European Commission has granted conditional approval for Idefirix in highly sensitized kidney transplants patients. The formal approval by the European Commission was received two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending conditional approval of […]
Pharma Business - June 7, 2019
Hansa Biopharma presents positive results at the American Transplant Congress
The company demonstrated a significant reduction in time on the waitlist for patients treated with imlifidase compared to matched controls at the 2019 American Transplant Congress, June 1 – 5, in Boston, Massachusetts, USA. In a plenary presentation on June 5, 2019, Edmund Huang, Associate Professor and Transplant Nephrologist at the Kidney and Pancreas Transplant Center […]
