Category ADVANCED THERAPY MEDICINAL PRODUCT

EC approves Siponimod for secondary progressive multiple sclerosis

Mayzent (siponimod) has been approved by the European Commission (EC) for adults with secondary progressive multiple sclerosis (SPMS) based on the results of the EXPAND trial. The European Commission (EC) has approved Mayzent (siponimod) for the treatment of adults with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. Approximately 80

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The Alliance for Regenerative Medicine Outlines Recommendations on Enabling Cross-border and Regional Access to Advanced Therapy Medicinal Products (ATMPs) in Europe

Establish an ATMP coordination body at EU/EEA level Ensure authorities in regions of treatment are compensated for costs of treating patients from other regions Encourage greater alignment within Europe on product value assessment activities The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector,

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The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011–2018

The majority of marketing authorizations granted through two expedited assessment pathways in Europe are based on non-validated surrogate endpoints rather than clinical outcomes, according to a study published September 10 in the open-access journal PLOS Medicine by Patricia McGettigan of Queen Mary University of London, and colleagues. The approval of new pharmaceutical products addressing an unmet need

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