Thumbs Up For EU Guidance On Advanced Therapy Trials
Guidelines Acknowledge That Non-Clinical Studies Are Not Always Feasible
New guidelines on good clinical practice for advanced therapies address the constraints most often encountered by developers conducting trials for these types of treatments.
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A new EU draft guideline on clinical trials with ATMPs outlines a number of areas where specific requirements and safeguards might be needed when testing these often complex and novel products in humans.
Health technology assessment body NICE wants Kite to collect more evidence to prove that Tecartus can cure relapsed or refractory mantle cell lymphoma. But in the meantime, it says the CAR-T therapy should be made available on the National Health Service, making UK patients among the first in the world to be offered access to the treatment.
New medicines under evaluation at the European Medicines Agency.