da Luca Bonadei | Mag 7, 2021 | Regulatory
https://www.pharmastar.it Janssen announced that it has applied for marketing authorization to EMA for CAR-T therapy, for the treatment of patients with relapsed/refractory multiple myeloma. This is an experimental therapy with ciltacabtagene autoleucel (cilta-cel)...
da Luca Bonadei | Mar 27, 2021 | Regulatory
https://www.pharmastar.it/ The U.S. Food and Drug Administration approved idecabtagene vicleucel (Abecma), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines...
da Luca Bonadei | Feb 6, 2021 | Regulatory
https://www.pharmastar.it The U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large...
da Luca Bonadei | Feb 1, 2021 | Regulatory
https://www.pharmastar.it Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) will perform an accelerated assessment of the Marketing...
da Luca Bonadei | Dic 22, 2020 | Regulatory
https://www.telethon.it The European Commission granted full (standard) market authorization for the world’s first gene therapy for the treatment of a rare and very serious neurodegenerative disease metachromatic leukodystrophy. Libmeldy is the result of the...
da Luca Bonadei | Dic 16, 2020 | Regulatory
https://www.pharmastar.it European Commission has now granted conditional marketing authorization for CAR-T Tecartus, drug developed by Kite, now a subsidiary of Gilead Sciences committed to cell therapy for cancer treatment. Tevartus is first cell therapy for the...
