Medical Device News Magazine

“This strategic endeavor represents a significant step forward in our commitment to advancing newborn health through innovative genomic technologies,” said Yves Dubaquie, senior vice president, diagnostics at Revvity. “By combining our expertise in newborn screening and rare disease detection with Element’s technological capabilities, Revvity aims to deliver a robust, efficient, and accessible solution for neonatal sequencing in both research and clinical settings.”

“The submission of the BLA marks a pivotal step for Capricor Therapeutics and those impacted by DMD. This BLA is the culmination of a body of work that has been focused on bringing this potentially transformational therapy to those patients in need,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “We believe that the strength of this application is that deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. We look forward to working with the FDA throughout the review process to support this potential approval.”

“Our longstanding commitment to operational resilience has positioned us to navigate these challenges effectively,” said Dr. Ko Chung Lin, CEO of PharmaEssentia. “We recognize that dependable medication supply is essential, and we are working closely with our partners around the world to ensure the continuity of these important therapies. We have made substantial investment to ensure that all of our supply chain elements are strong, of the highest quality, and reliable.”