• Regulatory NewsRegulatory News

    FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy

    The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy. Although the outside panel of experts raised questions about concerns with the safety and manufacturing of the Novartis treatment, known as CTL019 (tisagenlecleucel-T), the panel did not question the effi...
  • Regulatory NewsRegulatory News

    EMA Adds Four New Drugs to PRIME Scheme

    The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight. Like the US Food and Drug Administration's (FDA) breakthrough therapy program, PRIME aims to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors in order to facilitate an accelerated product assessme...