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    Inicio > Historias > Molmed retira la autorización de Zalmoxis 2019-10-12

    Molmed retira la autorización de Zalmoxis

    Tras entrar una vez más, a la web de Molmed a buscar novedades, veo la fea, pero previsible,  noticia:


    Milano (Italia), 10 ottobre 2019 – MolMed S.p.A. (MLMD.MI), azienda biotecnologica focalizzata su ricerca, sviluppo, produzione e validazione clinica di terapie geniche e cellulari per la cura del cancro e malattie rare, facendo seguito a quanto comunicato il 27 giugno scorso, comunica la propria decisione di ritirare per motivi commerciali il Conditional Marketing Authorization di Zalmoxis, adottata dalla Commissione Europea con delibera del 9 ottobre 2019.


    Lo comunicado el 27 de junio era:

    MolMed announces the decision to suspend the enrollment of new patients in phase III study TK008 with Zalmoxis®.


    Milan (Italy), June 27th 2019 - MolMed S.p.A. (MLMD.MI), a biotechnology company focused on research, development, production and clinical validation of gene and cell therapies for the treatment of cancer and rare diseases, announces the suspension of the enrollment of new patients in the phase III clinical trial with Zalmoxis® named TK008.


    In reviewing the product development plan, the Company decided to conduct an unplanned interim analysis on the first 90 patients included in the study, representing approximately 50% of the total number of patients required by the protocol. This analysis, although not conclusive, has not shown an advantage of the arm treated with Zalmoxis® compared to the control arm treated with the standard of care, with reference to the primary endpoint of the study, namely disease-free survival


    Con todo ello nos quedaríamos en nueve ATMP´s autorizados y cinco que han perdido la Marketing Authorization.



    He tenido que modificar la presentación de la charla que el próximo día 16 de octubre a las 13 horas voy a dar sobre los ATMP´s autorizados por la EMA  en el Centro de Salud Pública de Castellón (Avda del Mar, 8, 12003 Castellón). Espero sea de interés para mis compañeros de centro de trabajo.

    El contenido del blog no tiene relación directa con mi trabajo, sino con mis aficiones y homenajes.


    2019-10-12 06:32 | 15 Comentarios


    Referencias (TrackBacks)

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