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Revision of the EU’s pharmaceutical legislation
Background on the reformIn April 2023, the European Commission (EC) published two proposals to revise the existing (and outdated) pharmaceutical legislation. This includes legislation on medicines for children and rare diseases.
Read moreSubstances of Human Origin (SoHO) legislation
EHA’s involvementEHA has been involved in both the evaluation and subsequent revision of the EU legislation on human blood and blood components. The evaluation of these rules, which dated back to 2002, began in 2016.
Read morePublications
Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities
Lubbers, Bart R. ; Dombrink, Isabel; Kalina, Tomas; Hofmans, Mattias; Bruun, Morten S. ; Stanworth, Simon J. ; Béné, Marie C.
Meeting Report: European School of Haematology International Conference of Haematological Disorders in the Elderly
The meeting started by reviewing demographic aspects, physiological changes encountered in the elderly, as well as the definition of older and elderly people, frailty and comorbidity.
Read moreImplementation of the new EU Regulation for In Vitro Diagnostic Medical Devices: a ticking time bomb for the diagnostic sector.
Urgent actions are needed now to prevent a collapse of diagnostic testing.
Read moreAdding elotuzumab to standard treatment for multiple myeloma significantly reduced the risk of disease progression, with benefits sustained at two years
ELOQUENT-2, which evaluated elotuzumab in combination with lenalidomide and dexamethasone, is the first Phase III study to demonstrate the benefit of directly activating the immune system in the treatment of patients with relapsed or refractory multiple myeloma.
Read moreFDA Reports of Secondary Malignancies Following Chimeric Antigen Receptor (CAR) T Cell Therapies and Relative Risk: an EBMT-EHA-GoCART Coalition Statement
We need to bring your attention to the recent warning disseminated by the Food and Drug Administration (FDA) regarding T-cell lymphomas in patients undergoing Chimeric Antigen Receptor T-cell (CAR-T) therapy (1).
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