CAR T-Cells, Helping US Firms & An “Ambitious” Plan For Advanced Therapies In The EU
As companies like Novartis, bluebird bio and Kite Pharma press on with developing cancer treatments based on cutting edge CAR T-cell technology, the new chair of the European Medicines Agency’s Committee for Advanced Therapies, Martina Schüssler-Lenz, tells the Pink Sheet about plans to help makers of these and other innovative advanced therapies.
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The European Medicines Agency is updating its five-year old guideline on drugs containing genetically modified cells to factor in rapid scientific developments in relation to gene editing technologies, and the development of promising new cancer immunotherapies, such as CAR-T cells.
Labeling, logistics and other issues were on the table as industry experts discussed the potential upcoming launches of CAR-T therapies in the US. Datamonitor Healthcare reported live from the ARM conference.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.