Tuesday, June 4, 2019 Daily Archives

Stem cell clinic crackdown continues with FDA letter to R3

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Despite receiving an untitled letter from the US FDA over its promotion of unapproved stem cell therapies, Arizona firm R3 Stem Cell, LLC continues to push its questionable therapies to “vulnerable patients.†The US Food and Drug Administration (FDA) has put Scottsdale, Arizona-based company R3 Stem Cell on notice for marketing unapproved stem cell treatments. In the untitled letter dated May 30, the Agency said R3, through its affiliated clinics, offers unapproved stem cell products for serious conditions including Lyme…

June 4, 2019

Single-Use Technology in Upstream Processing: A Roundtable Discussion

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The Sartorius upstream portfolio addresses key strategic challenges facing the biopharmaceutical industry: Increased speed to clinic/market and lowered capital costs, with improved process control. Fully scalable, proven process solutions for cell line, media, and process development through commercial manufacturing accelerate upstream development and simplify manufacturing. Novel high-throughput development tools for intensified processes incorporate the latest in process analytics, multivariate data analysis (MVDA), and design of experiments (DoE) software tools. These tools are designed to compress development timelines and to scale…

June 4, 2019

Rexgenero adds CMO to speed up cell therapy trials

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Regenerative medicine firm has contracted the German Red Cross Blood Donor Service to expand production of its autologous bone marrow-based cell therapy REX-001. London, UK-headquartered firm Rexgenero’s lead product is REX-001 is in two Phase III trials both of which are in diabetes patients. The firm manufactures the autologous cell therapy from its production site in Seville, Spain, added through its incorporation of Spanish subsidiary Rexgenero Biosciences S.L in 2015. But to increase production and expedite clinical trials, the firm has…

June 4, 2019