• Regulatory NewsRegulatory News

    Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’

    Research published this week in PLOS Medicine raises concerns about the use of surrogate endpoints to support the marketing authorizations of products assessed via the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA) and accelerated assessment (AA) pathways. The use of the CMA and AA pathways, which is restricted to situations of “unmet medical need” and/or “in the interests of public health,” are often based on incomplete benefit-risk asses...
  • Regulatory NewsRegulatory News

    700% Price Spike Spurs UK to Allege Four Pharma Companies Agreed to Restrict Competition

    The UK’s Competition and Markets Authority (CMA) on Thursday alleged that Focus Pharmaceuticals, Medreich, Alliance Pharmaceuticals and Lexon have breached UK and EU law by entering into anti-competitive agreements that restricted the supply of the nausea and dizziness drug prochlorperazine. Under two alleged agreements discovered by CMA, Alliance Pharmaceuticals supplied prochlorperazine exclusively to Focus Pharmaceuticals. And Focus paid Lexon a share of the profits ...
  • Regulatory NewsRegulatory News

    EMA Reflects on its First Decade of Conditional Marketing Authorizations

    Ten years after the development of the conditional marketing authorization (CMA) pathway, European Medicines Agency (EMA) on Monday said the program is working as intended, and has led to earlier patient access to 30 drugs, nearly half of which were for orphan indications, and 80% of which target seriously debilitating or life-threatening conditions. Additionally, EMA says that the majority of products granted conditional marketing authorization were either for indicatio...