The Blood and Cell Advocacy Register (BCAR) is a newly launched consortium that aims to revolutionize the development and commercialization of advanced therapy medicinal products (ATMPs). Formed in December 2024, BCAR brings together experts and organizations from the blood and cell industries to
In a groundbreaking partnership aimed at revolutionizing the production processes for stem cell-based therapies, Mytos has joined forces with Aspen Neuroscience to enhance the manufacturing of autologous dopaminergic neuronal precursor cells (DANPCs). These cells are integral to Aspen’s ANPD001, an
CAR-T cell therapy has emerged as a groundbreaking approach in cancer treatment, leveraging the body's immune system to target and destroy cancer cells. Since its inception in 2017, this innovative therapy has rapidly evolved, with numerous products reaching commercialization and receiving
The pharmaceutical and biotechnology sectors are witnessing a whirlwind of significant developments, from legal disputes over acquisition terms to pivotal personnel changes and strategic restructuring initiatives. These shifts are emblematic of an industry in constant evolution, driven by
BioMarin Pharmaceutical Inc. has made headlines with its announcement of a significant €60 million investment geared towards the expansion of its state-of-the-art facility located in Shanbally, Co. Cork. This ambitious expansion plan encompasses the construction of a new four-story laboratory b
Earlier this week, the U.S. Food and Drug Administration (FDA) unveiled its much-anticipated final guidance on predetermined change control plans (PCCPs) for devices incorporating artificial intelligence and machine learning (AI/ML) software. This guidance signifies a significant milestone in the
