What do we know of the safety and efficacy of stem cell therapeutics? Over 50 years have passed since the discovery of hematopoietic stem cells (bone marrow transplantation to cure diseases such as leukemia), over 24 years since the discovery of human embryonic stem cells (hESC), and 18 years since the discovery of induced pluripotent stem cells (iPS cells). There are now thousands of stem cell trials underway in clinics worldwide. Despite this experience, what do we actually know about the safety and efficacy of stem cell therapeutics? [Read more…]
Big Pharma Makes M&A Moves to Secure Positions in In Vivo Cell Engineering
Across 2025, a striking trend has emerged in biotechnology. Major pharmaceutical companies are racing to acquire in vivo cell engineering platforms, signaling that reprogramming cells inside the body has moved from speculative science to strategic priority.
In just a few months, the field has transformed. AstraZeneca, AbbVie, Gilead’s Kite Pharma, and Bristol Myers Squibb have all made acquisitions designed to accelerate their capabilities in in vivo cell therapy. Each deal highlights the growing importance of technologies that can directly engineer immune cells without removing them from the body. [Read more…]
FDA Grants RMAT to iRegene’s NouvNeu001, Making It World’s First iPSC Therapy with FTD and RMAT Recognitions
Designation underscores potential of chemically induced, off-the-shelf cell therapy to address high unmet need in Parkinson’s disease, following compelling Phase I clinical data
CHENGDU, China, Jan. 19, 2026 — iRegene Therapeutics Co., Ltd. (“iRegene” or the “Company”), a biotechnology company pioneering chemically induced allogeneic cell therapy, today announced that its lead product, NouvNeu001, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease (PD). [Read more…]
History of Cord Blood and Tissue Banking: Landmark Events and Pivotal Trends
The global cord blood industry came into existence in the early 1990’s with the formation of several leading cord blood banks in the USA, followed by the establishment of cord blood banks across the globe. However, the history of cord blood stem cell transplantation begins much earlier than that. [Read more…]
Ways to Curb the Sky-high Costs of CAR-T Cell Therapy
CAR-T therapy has revolutionized cancer treatment, offering a personalized approach that uses genetically modified T cells to target and destroy cancer cells. However, this breakthrough treatment comes at a steep price. In the U.S., CAR-T therapies are priced between $300,000 and $600,000, and when factoring in the costs of treating adverse reactions and hospital stays, the total expenditure can exceed $1,000,000. The high cost makes it inaccessible for many patients and poses a challenge for healthcare systems worldwide.
To address this issue, experts and industry leaders have proposed several strategies to reduce the cost of CAR-T therapy while maintaining its efficacy and accessibility. [Read more…]
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