CAR-T Cells Addressed In Updated EMA Guide On Drugs Containing Genetically-Modified Cells
The European Medicines Agency's current thinking on the clinical development of CAR-T cells is outlined in a new annex.
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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.
An EU funded project is to help national competent authorities cooperate on the safety assessment of clinical trials as required under the Clinical Trial Regulation.
A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection.