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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EMA Reviewing Guide To Support New Genome Editing Technologies, CAR-T Cell Therapies
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.
Decade-Old Advanced Therapy Set For EU Approval
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.
BMS & Pfizer Win Funding ‘Firsts’ In England For Migraine & Heart Disease Drugs
Bristol Myers Squibb and Pfizer both asked the health technology assessment body NICE to evaluate their respective drugs, Camzyos and Vydura, for use in indications that are narrower than those for which they are – or will potentially be – approved.