Rejigging The Benefit-Risk Balance For Advanced Therapies In The EU
The European Medicines Agency’s Committee for Advanced Therapies has revealed its priorities for addressing the challenges manufacturers face in the fast-growing field of 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.
German company CO.DON is celebrating the fact that it probably won’t be long before it can start selling across Europe its key product – an advanced therapy for the repair of certain cartilage defects of the knee that’s been in use in Germany for ten years.
Santhera Pharmaceuticals’ vamorolone for treating Duchenne muscular dystrophy is among the latest medicines that have been submitted for review for potential pan-EU approval.