The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals.
The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals.
Phase I/II data of IDCT (rebonuputemcel), a cell therapy in development for chronic and progressive lumbar degenerative disc disease and one that has both regenerative medicine advanced therapy and fast track designations in the U.S., has been published in the International Journal of Spine Surgery for showing statistically significant improvements in pain, disability and quality of life.
One of the key advances in regenerative medicine has been the engraftment of external epithelial stem cells to supplement or replace damaged native cells. However, the difficulty in engrafting internal tissues has hindered the long-term rescue of diseased internal epithelia, such as those in the respiratory airways.
Peptigrowth Inc. and Orizuru Therapeutics Inc. have entered into a joint development agreement to create a novel synthetic peptide that will replace a recombinant growth factor used in the manufacturing of a regenerative medicine product being developed by Orizuru.
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
Tenpoint Therapeutics Ltd. raised $70 million in a series A funding round to pursue ambitious plans to reverse vision loss using both ex vivo cell engineering and in vivo cell reprogramming approaches.
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
Tessara Therapeutics Pty Ltd. is developing a technology platform that builds three-dimensional models of the human brain to treat neurological diseases such as Parkinson’s disease.
