Wow, a tremendous achievement has been accomplished by the stem cell community. We have officially surpassed 500,000 publications about stem cells on PubMed.gov! PubMed is a service of the U.S. National Library of Medicine and NIH that comprises more than 27 million citations for biomedical literature. It is the largest and most comprehensive global database that exists for scientific publications anywhere in the world. [Read more…]
PHILADELPHIA and MADISON, Wis. — Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immune-oncology, and FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human iPSCs and iPSC-derived cells, today announce a new worldwide license agreement and expansion of existing licenses for the development and commercialization of cell therapies derived from iPSCs for the treatment of autoimmune and inflammatory diseases, including type 1 diabetes, multiple sclerosis, lupus, and rheumatoid arthritis. [Read more…]
RMAT designation recognizes the potential of ATSN-101 to address unmet medical needs for patients with LCA1
ATSN-101 has demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious adverse events 6 months post-treatment in ongoing Phase I/II clinical trial
To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 83 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 238 requests and issued 92, 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 39% of RMAT applications get approved (92 approvals / 238 applications = 38.7%).
Thus far, Rocket Pharmaceuticals is the only company to receive four RMATs, while two other companies (AlloVir, CRISPR Therapeutics) have received three RMATs to date.
Additionally, nine companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, Cook MyoSite, Humacyte, Mesoblast, and Orchard Therapeutics) have managed to secure two RMAT designations from the U.S. FDA.
The most recently awarded RMATs were given to Editas-Medicine on October 16th for EDIT-301 and Immatics N.V. on October 24th for IMA203. [Read more…]
Today, induced pluripotent stem cells (iPSCs) are being exploited for uses in drug discovery and development, toxicology screening, disease modelling, personalized medicine, cell-based therapeutics, and beyond. A fascinatingly diverse range of business models have been developed by market competitors to provide iPSC specific products, services, technologies, and therapies across the life science sector. [Read more…]