• Regulatory NewsRegulatory News

    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
  • European Regulatory Roundup: Italy Fines Aspen $5.7M for Increasing Cancer Drug Prices by 1,500% (20 October 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Norwegian Government-Funded Study Supports Switching Patients to Remicade Biosimilar A trial funded by the Norwegian government has generated data to support switching from Johnson & Johnson’s Remicade to a biosimilar. Overall, participants with rheumatoid arthritis, Crohn’s disease and other conditions who switched to the biosimilar had comparable outcomes to patients ...