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Marie Gårdmark: Potential step change – EU regulators get to play with data
A new pilot from EMA is starting in September to assess wether the analysis of 'raw data' by regulatory authorities improves the evaluation of marketing approval for new medicines. Marie Grådmark writes in a column that she is looking forward to the outcome of the pilot to hopefully then understand if “in house” analyses actually will add value.
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CAR-T therapies give continued hope: “Almost half of the patients have become disease-free”
When the first CAR-T therapies appeared, hopes were raised for the effective treatment for critically ill cancer patients. After a somewhat sluggish start, about 90 patients in Sweden have now been treated with this method. “Almost half of them have become disease-free, at least of those treated with Yescarta, which are the ones I know best,” says Gunilla Enblad, Chairman of the national working group for CAR-T treatment.
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