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  • Regulatory NewsRegulatory News

    EMA Accepts Four Products to Priority Medicines Scheme

    The European Medicines Agency (EMA) on Wednesday released its first statistics for its PRIority MEdicines (PRIME) scheme, naming the first four products to become eligible for the program, which seeks to speed the development of promising new drugs and biologics. This is the first time EMA has released data signaling industry interest in PRIME since its launch in March. In total, EMA says it received 18 applications, mostly from small- and medium-sized companies, represe...
  • Regulatory NewsRegulatory News

    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...