Hansa Biopharma erhåller positivt CHMP-utlåtande för Idefirix

# HANSA BIOPHARMA: ANSÖKAN IMLIFIDASE I EUROPA

24 Sep 2019 At the upcoming meeting with the FDA, Hansa Biopharma intends to forward for a regulatory filing of imlifidase in kidney transplantation of av ZT Al-Salama · Citerat av 1 — Streptococcus (S.) pyogenes is being developed by Hansa Biopharma AB for treatment of transplant rejection and rare IgG-mediated autoimmune conditions. Hansa Biopharma erhåller positivt CHMP-utlåtande för Idefirix[TM] (imlifidase) för njurtransplantation inom EU. tor, jun 25, 2020 17:30 CET. Hansa Biopharma meddelar positiva resultat från den prövarinitierade fas 2-studien med imlifidase för behandling av anti-GBM sjukdom. …at Hansa Biopharma we envision a world where all patients ability to commercialize imlifidase if approved; changes in legal or regulatory. Imlifidase är ett unikt antikroppsklyvande enzym ursprungligen från Streptococcus pyogenes, som specifikt riktar sig mot IgG och förhindrar en IgG-medierad Imlifidase was granted eligibility to PRIME in May 2017. In the US, following overall agreement with the FDA, Hansa Biopharma submitted a Imlifidase beviljades tillträde till PRIME i maj 2017. I USA skickade Hansa Biopharma, efter överenskommelse med FDA, in ett studieprotokoll Hansa Biopharma bjuder in till en webbsänd telefonkonferens av bolagets bokslutskommuniké för 2020 samt ge en uppdatering av bolagets verksamhet. 01/11/ Hansa grants Sarepta exclusive license to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene Bolagets läkemedelskandidat imlifidase, ett enzym (IdeS) som eliminerar IgG-antikroppar, är i långt framskriden klinisk utvecklingsfas för The EU Commission granted conditional approval for Idefirix® (imlifidase) in highly sensitized kidney transplant patients in the European Union.

I slutet av juni gav den europeiska läkemedelsmyndighetens vetenskapliga kommitté ett positivt utlåtande om Hansas läkemedel för njurtransplantation Idefirix (imlifidase). Ett formellt godkännande väntas komma de närmaste månaderna. Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Hansa Biopharma lämnade in svar på EMA´s frågor per dag 120 den 20 december 2019. Ett utlåtande från CHMP väntas under andra kvartalet 2020. – Uppnått en överenskommelse med FDA om en regulatorisk väg framåt för imlifidase vid njurtransplantation hos högsensitiserade patienter i USA. Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases.

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Hansa Biopharma (“Hansa”), the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the European Commission has granted conditional approval for IdefirixTM in highly sensitized kidney transplants patients. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of IdefirixTM (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. CAMBRIDGE, Mass., July 02, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an agreement with Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare Immunoglobulin G (IgG) mediated diseases, for imlifidase. Hansa Biopharma has Agreed With the FDA on a Regulatory Path Forward for Imlifidase in Kidney Transplantation of Highly Sensitized Patients in the U.S. PR Newswire LUND, Sweden, Dec. 13, 2019 LUND During 2020 Hansa Biopharma AB certified as A Great Place to Work company, by the independent institute Great Place to Work ®, a global authority on workplace culture, employee experience and leadership behaviour.

Tulstrup, vd Hansa Biopharma: Fokus på Imlifidase - Expressen

The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Sarepta Therapeutics, Inc. (SRPT), the leader in precision genetic medicine for rare diseases, today announced an agreement with Hansa Biopharma, the leader in immunomodulatory enzyme technology 2021-03-29 2019-04-29 2019-03-01 Hansa Biopharma AB ”Hansa” (Nasdaq Stockholm: HNSA), som är ett banbrytande bolag inom enzymteknik för sällsynta immunologiska sjukdomar, offentliggör idag årsredovisningen för 2020. Søren Tulstrup, vd och koncernchef, Hansa Biopharma kommenterar årsredovisningen: 2020 var ett mycket framgångsrikt och omvälvande år för Hansa Biopharma – ett år då vi upplevde betydande […] Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Hansa Medical Receives FDA Fast Track Designation for Imlifidase for Transplantation Wed, Oct 17, 2018 08:00 CET. Lund, Sweden, October 17, 2018- Hansa Medical AB (NASDAQ Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the U.S. Food and Drug Administration (FDA) has granted imlifidase Fast Track Hansa Biopharma (”Hansa”), ledaren inom immunmodulerande enzymteknik för behandling av sällsynta IgG-medierade sjukdomar, meddelar idag positiva resultat från en prövarinitierad fas 2-studie som utvärderar säkerheten, tolerabiliteten och effekten av imlifidase hos 15 patienter med svår anti-GBM.
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Hansa Biopharma is hosting a Capital Markets Day planned for October 29, 2020 in Copenhagen, where more information from the anti-GBM phase 2 trial will be presented. Hansa Biopharma (“Hansa”), the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the European Commission has granted conditional approval for IdefirixTM in highly sensitized kidney transplants patients. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of IdefirixTM (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. CAMBRIDGE, Mass., July 02, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an agreement with Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare Immunoglobulin G (IgG) mediated diseases, for imlifidase. Hansa Biopharma has Agreed With the FDA on a Regulatory Path Forward for Imlifidase in Kidney Transplantation of Highly Sensitized Patients in the U.S. PR Newswire LUND, Sweden, Dec. 13, 2019 LUND During 2020 Hansa Biopharma AB certified as A Great Place to Work company, by the independent institute Great Place to Work ®, a global authority on workplace culture, employee experience and leadership behaviour. We are immensely proud.

Hansa Biopharma. Redeye Event. May 27 2020. Video Thumbnail . 23 Dec 2020 Hansa Biopharma , the leader in immunomodulatory enzyme technology for Imlifidase is additionally being evaluated for further use in other 13 Aug 2020 Hansa Biopharma's lead project, imlifidase (IdeS), is a proprietary antibody degrading enzyme, currently in late-stage clinical development for 15 Oct 2020 Hansa Biopharma and the beacon logo are trademarks of Hansa 2020 Hansa Biopharma AB. Imlifidase data and practical experiences.
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Sarepta Therapeutics Signs Agreement with Hansa Biopharma for Imlifidase. PRESS RELEASE GlobeNewswire . Jul. 2, 2020, 01:00 PM Hansa Biopharma har fått godkänt att starta fas 2-studie med imlifidase i Guillain Barrés syndrom mån, apr 15, 2019 08:30 CET. Lund den 15 april 2019 - Hansa Biopharma AB (NASDAQ Stockholm: HNSA), ledande inom immunmodulerande enzymteknik för behandling av sällsynta IgG-medierade sjukdomar tillkännager idag att bolagets fas 2 studie med imlifidase i Guillain Barrés syndrom (GBS) är Hansa Biopharma (“Hansa”), the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announces positive high-level data from an investigator-initiated phase 2 trial that evaluated safety, tolerability and efficacy of imlifidase in 15 … 2019-04-15 Lund, Sweden August 30, 2019. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced today that new imlifidase data will be highlighted in a presentation at the 19th Congress of the European Society for Organ Transplantation (ESOT), taking place September 15 to 18, 2019 in Copenhagen, Denmark. Lena Winstedt, PhD, Head of Science på Hansa Biopharma, presenterade ”Imlifidase For Desensitization in Sensitized Kidney Transplant Patients: Pooled Analysis of Phase 2 Trials”.

Redeye Event. December 1 2020. Video Thumbnail.
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Hansa Biopharma receives positive CHMP opinion for Idefirix

Akut AMR är en utmanande komplikation efter njurtransplantation och utvecklas hos 10 till 15 procent av patienterna. Den 25 juni 2020 erhöll Hansa Biopharma ett positivt utlåtande från CHMP vid Europeiska läkemedelsmyndigheten (EMA) som rekommenderade ett villkorat godkännande av Idefirix (imlifidase) för desensitiserings-behandling av högsensitiserade vuxna patienter som ska genomgå en njurtransplantation och som uppvisar ett positivt korstest mot en tillgänglig avliden donator. Hansa Biopharma meddelar att amerikanska läkemedelsmyndigheten FDA vill att bolaget genomför en ny klinisk studie med imlifidase som en del av en så kallad BLA-ansökan (Biologic Licens Application). Jag återvände nyligen från 2019 American Transplant Congress (ATC) i Boston där jag upplevde ett mycket stort intresse för Hansa Biopharma, vår teknikplattform och vår projektportfölj.