WUHAN, China, June 24, 2024 — On June 20 (UTC-4), the U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene therapeutics targeting Parkinson’s Disease. This marks a significant milestone as NouvNeu001 becomes the world’s first chemically induced allogeneic cell therapy product to enter clinical stages for Parkinson’s disease in the US. Previously, the “Combined Phase I/II Clinical Study” of NouvNeu001 had already received approval from China NMPA in August 2023 and demonstrated positive safety and efficacy data in its Phase I trials. On June 20, 2024, iRegene further announced IND approval of NouvNeu001 by the U.S. FDA for the treatment of mid-to-late stage of Parkinson’s disease. [Read more…]
Interview with Patrick Lucy, President and CEO of Lykan Bioscience
This is an interview with Patrick Lucy, President and CEO of Lykan Bioscience. Lykan is an innovative cell therapy-focused contract development and manufacturing organization (CDMO) headquartered in Hopkinton, MA. In this interview, we discuss the vision of Lykan Bioscience, its innovative and agile approach to CDMO services, and the company’s future goals. Enjoy! [Read more…]
Pivotal Trends Impacting the Global Cord Blood and Tissue Industry in 2024
The cord blood industry came into existence in the early 1990’s with the formation of several cord blood banks in the U.S. and worldwide. It has been 40 years since it was first proposed that stem and progenitor cells were present in human cord blood. [Read more…]
What Is An RMAT? List of Publicly Announced RMAT Designations (102)
To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 102 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 279 requests and issued 128, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 46% of RMAT applications get approved (128 approvals / 279 applications = 45.9%). [Read more…]
Creative Medical Technology Announces iPSCelz® Program Has Generated iPSC Derived Islet Cells that Produce Human Insulin
PHOENIX, June 24, 2024 — Creative Medical Technology Holdings, Inc. (“Creative Medical Technology” or the “Company”) (NASDAQ: CELZ), a leading commercial stage biotechnology company focused on a regenerative approach to immunotherapy, urology, neurology, and orthopedics, today announced that it has successfully generated human induced pluripotent stem cells (iPSC)-derived Islet Cells that produce human insulin. [Read more…]