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How Europe can work together on SoHO to meet patient needs

As SoHO Regulation discussions advance in the European Parliament and Council, it is more important than ever to recognise the contribution of all stakeholders to securing Europe’s supply of plasma and plasma-derived therapies within a resilient global plasma ecosystem. ....

Czech Republic , Lutz Bonacker , European Commission , European Parliament , European Health Taskforce Summit , Council Of Europe Committee On Bioethics , Commercial Operations Europe , Human Origin , Fundamental Rights , Europe Committee , European Health Taskforce ,

EC approves first gene therapy for adults with haemophilia B

EC approves first gene therapy for adults with haemophilia B
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United Kingdom , Lutz Bonacker , European Commission , Medicinal Products , Human Use , Bill Mezzanotte ,

Europe approves CSL's first gene therapy for Haemophilia B

Europe approves CSL's first gene therapy for Haemophilia B
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United Kingdom , Lutz Bonacker , European Commission , Regulatory Agency , Commercial Operations ,

First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission

Global biotechnology leader CSL (ASX: CSL) today announced that the European Commission has granted conditional marketing authorization (CMA) for HEMGENIX® (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX . ....

United Kingdom , Wolfgang Miesbach , Lutz Bonacker , Care Center , European Commission , Regulatory Agency , European Union , University Hospital Of Frankfurt , European Medicines Agency , Committee For Medicinal Products Human Use , Head Of Research Development , European Economic Area , Bill Mezzanotte , Chief Medical Officer , Medicinal Products , Human Use , Professor Wolfgang Miesbach , Coagulation Disorders , Comprehensive Care Center , University Hospital , Senior Vice President , General Manager , Commercial Operations Europe , Drug Administration , Annual Bleeding Rate ,

First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission

/PRNewswire/ Global biotechnology leader CSL (ASX: CSL) today announced that the European Commission has granted conditional marketing authorization (CMA). ....

United Kingdom , Stephanie Fuchs , Wolfgang Miesbach , Greg Healy , Kim Odonohue , Lutz Bonacker , Jimmy Baker , Care Center , European Commission , Regulatory Agency , European Union , University Hospital Of Frankfurt , European Medicines Agency , Committee For Medicinal Products Human Use , Head Of Research Development , European Economic Area , Bill Mezzanotte , Chief Medical Officer , Medicinal Products , Human Use , Professor Wolfgang Miesbach , Coagulation Disorders , Comprehensive Care Center , University Hospital , Senior Vice President , General Manager ,