Category ADVANCED THERAPY MEDICINAL PRODUCT

Toward an Optimized Process for Clinical Manufacturing of CAR-Treg Cell Therapy

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

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Modulating endothelial adhesion and migration impacts stem cell therapies efficacy

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

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Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 following a new report by ARM

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

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Alliance for Regenerative Medicine: Pharmaceutical Strategy Could Save European ATMP Development

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

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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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