The global CAR-T market has grown exponentially since the first CAR-T approval reached the market in 2017. Over the past four years, a growing pipeline of CAR-T clinical trials have been accumulating, leading to five global approvals and an explosion of CAR-T market competitors worldwide. [Read more…]
To date, 55 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 173 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 four companies (Abeona Therapeutics, Athersys, Rocket Pharmaceuticals, and CRISPR Therapeutics) have received two RMAT designations from the U.S. FDA.
DRESDEN, Germany, 9 November, 2021 / BioInformant / — denovoMATRIX GmbH and Saint-Gobain Life Sciences have entered into a Master Service Agreement focused on optimizing the performance of new products in development for adherent cell culture and harvest for autologous therapies. The relationship will further explore the synergy of consumable products from both parties and their positive effects for the therapeutic market. [Read more…]
CAR-T cell therapy is as a type of immunotherapy that teaches T cells to recognize and destroy cancer. CAR-T cell therapy has demonstrated promising results in a range of patients across the globe. In some patients, this can lead to the total elimination of the cancer. In others, there is a significant improvement of the disease.
For those who are facing cancer, it is important to answer the question “What is CAR-T?” This guide will answer the most common questions about CAR-T cell therapy for readers who want to understand this novel technology platform for treating cancer. [Read more…]
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…]