First Academic Sponsor On EMA’s PRIME Pledges Cheaper CAR-Ts
An investigational CAR T-cell therapy that hospital researchers in Spain believe they could produce at a third of the price of commercially available CART19 products has been accepted onto the European Medicines Agency's priority medicines scheme.
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Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.
The European Medicines Agency’s human medicines committee, the CHMP, is expected to decide whether 11 drugs should be recommended for marketing approval during its latest monthly meeting, which started today.
The level at which model-based analyses is integrated into regulatory decision-making can vary between regulatory agencies, from application to application and within agencies for similar submissions, leading to missed opportunities, says the International Council for Harmonisation.