The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and the sixth approved CAR-T product globally
Currently the only approved CAR-T product that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designation
May provide a best-in-class CAR-T therapy in China given its demonstration of high rates of durable disease response and low rates of CAR-T associated toxicities
The Pipeline for iPSC-Derived Cell Therapeutics in 2021
Despite progress involving the use of induced pluripotent stem cells (iPSCs) within disease modeling and drug discovery applications, it will be a long path to achieve the broad-scale use of iPSC-derived cell types in human patients. [Read more…]
Stem Cell Treatment For Hair Loss
The latest development in stem cell research – stem cell treatment for hair loss – shows great promise for stimulating new hair growth. It addresses the problem of thinning hair for both men and women.
When hair growth slows with age, many people feel despondent, depressed, less confident, and generally unhappy. The prospect of a continuing downhill slide makes the situation even worse, which is why stem cell transplant for hair loss has become a big business in the last several decades. [Read more…]
CAR-T Cell Companies Proliferate: List of CAR-T Companies Worldwide
CAR-T cell therapy is as a type of immunotherapy that teaches T cells to recognize and destroy cancer. This article provides a comprehensive list of CAR-T therapy companies worldwide. Read on to learn more about innovative CAR-T cell therapy companies and the technologies they are using to fight cancer.
In this article:
What Is An RMAT? List of RMAT Designations (53)
To date, 53 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 170 requests and issued 64, which means that a handful are not yet public knowledge.
Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
Thus far, only three companies (Abeona Therapeutics, Athersys, and Rocket Pharmaceuticals) have received two RMAT designations from the U.S. FDA.
