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
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,
The country’s health department is now sharing study results on new drugs and treatments online. Transparency advocates want the U.S. to do the same. Health Canada has posted safety and efficacy data online for four newly approved drugs; it plans to release reports for another 13 drugs and three medical devices approved or rejected since March. Source
In new research looking at pivotal trials for new cancer drugs approved by the European Medicines Agency between 2014 and 2016, researchers found only a quarter of trials use overall survival as a primary endpoint. Trials for cancer drugs undertaken in Europe in the mid-2010s were flawed to such a degree as to “raise questions”
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
