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…]
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…]
Theragent and Pluristyx Enter Partnership to Streamline and Advance iPSC-derived Therapy Development
ARCADIA, Calif., May 7, 2024 — Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell- and tissue-based therapies, has announced a partnership with Pluristyx, Inc., an early stage, privately held biotechnology company specializing in induced Pluripotent Stem Cell (iPSC) products. Combined, this partnership will allow the companies to provide a seamless, end-to-end pathway to therapeutics developers from iPSC derivation to commercial production of iPSC-derived drug products. [Read more…]
REPROCELL USA Inaugurates GMP Manufacturing Facility for hiPSCs and hMSCs Suitable for Therapeutic Use
REPROCELL to offer a Master Cell Bank (MCB) manufacturing service for the generation of Human Induced Pluripotent Cells (hiPSCs) and Human Mesenchymal Stem Cells (hMSCs) for human therapeutic applications.
BELTSVILLE, Md., May 29, 2024 — REPROCELL has been producing clinically relevant human induced pluripotent stem cells (hiPSCs) by controlling the process of donor recruitment to seed stock hiPSC and encompassing donor eligibility with different geographical regulatory agencies. Raw materials undergo strict selection and a proprietary method of footprint-free RNA reprogramming is used. [Read more…]
Biotherapies Pavilion Back by Popular Demand at 2024 AABB Annual Meeting in Houston, Texas
June 1, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce the return of the Biotherapies Pavilion at the 2024 AABB Annual Meeting, which will take place Oct. 19-22 in Houston, Texas. AABB introduced the inaugural Biotherapies Pavilion in 2023 as a specially designed networking space in the Exhibit Hall, providing biotherapies companies with new and curated opportunities to network with key audiences in the field and gain access to all that the AABB Annual Meeting has to offer including: [Read more…]
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