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  • Regulatory NewsRegulatory News

    EMA Restricts Use of Biogen MS Drug

    The European Medicines Agency (EMA) on Friday announced it is provisionally restricting the use of Biogen Idec’s multiple sclerosis (MS) medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that have failed to respond to other drugs, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.  In addition, EMA said, "patients with liver injury must not be given the medicine. Starting treatment with ...
  • 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...