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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EU to Revoke Antibiotic Spray Authorizations (7 April 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Countries to Revoke Fusafungine Spray Authorizations Following CMDh Decision Member states of the European Union are set to revoke the marketing authorizations of fusafungine sprays. The action follows a Pharmacovigilance Risk Assessment Committee (PRAC) review that found the risks of serious allergic reactions associated with the antibiotic and anti-inflammatory no...
  • Regulatory NewsRegulatory News

    EMA Issues New Guideline on Gene Therapy

    The European Medicines Agency (EMA) is seeking feedback on a new draft guideline aimed at clarifying the scientific evidence necessary to support the authorization of new gene therapies. Background Gene therapy works by modifying a patient's genes to correct for genetic issues. Researchers have been studying gene therapy for the past 30 years, but few products have reached advanced stages of development. Because so few gene therapies have been submitted for authorizatio...
  • Regulatory NewsRegulatory News

    Following Negative Comments by Reviewer, EU Committee OK's Gene Therapy

    Last month, German regulators postponed their review of UniQure's gene therapy Glybera after the European Medicines Agency (EMA) rapporteur assigned to the product claimed new data showed Glybera lacked efficacy and called for it to be reassessed . Now, EMA's Committee for Advanced Therapies (CAT) has completed its assessment, and is maintaining its positive opinion of Glybera, Reuters reports. Background Glybera is the first gene therapy approved for use in the E...
  • Regulatory NewsRegulatory News

    First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report

    Regulators at the German Federal Joint Commission (G-BA) have postponed their review of the gene therapy Glybera, Reuters reports . The decision was made after the European Medicines Agency (EMA) rapporteur assigned to Glybera found the product lacked efficacy and called for it to be reassessed. Glybera, which treats a rare condition called lipoprotein lipase deficiency (LPLD), made headlines both for being the first gene therapy approved in Europe and for its record-...
  • CHMP Recommends EU's First Gene Therapy Product

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use the first gene therpy product in the European Union, regulators said Friday, 20 July. Glybera (alipogene tiparvovec), manufactured by UniQure, is intended to treat lipoprotein lipase deficiency-an ultra-rare disease that renders patients unable to break down dietary fat. Current therapies for the disease are dietary oriented, with patients required to ea...