Chimeric antigen receptor (CAR) technology and its application to regulatory T cells (Tregs) has garnered interest among researchers in the field of cell and gene therapy. Merging the benefits of CAR technology with Tregs offers a novel and promising therapeutic option for durable reshaping of undesired immune responses following solid organ or hematopoietic stem cell
Despite the first clinical studies reporting on a correlation betweenthe migration potential of transplanted stem cells and their therapeutic efficacy, it is unclear if effective stem cell therapies requirereliable and sufficient delivery of the cells to the desired anatomiclocations, as well as survival of the cellular graft. Moreover, the many complex processes involved in stem
In the early days of COVID-19, the Alliance for Regenerative Medicine (ARM) was unsure how the pandemic and its accompanying economic downturn would affect the cell and gene therapy space. “It was a really specific time when the world and the markets were clearly reeling from the first appreciation for the seriousness of COVID-19,” Janet
The Alliance for Regenerative Medicine (ARM) welcoming the opportunity to provide feedback on the roadmap to the EC pharmaceutical strategy has sent the following response. ARM is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs) and represents the interests of 350+ members worldwide and 70+ members across
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
