Business Trends– category –
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BMS In Vivo CAR-T: Phase 1 Trial Timeline for Autoimmune Diseases
BigGo Finance South Korea Overview Bristol Myers Squibb (BMS) is launching the first large-scale Phase 1 trial of an in vivo CAR-T therapy targeting autoimmune diseases rather than cancer. The trial, utilizing candidate BMS-986553, aims ... -
ReHeart iPS-derived Heart Muscle: Second Global Surgery at Kyushu University Hospital
Yomiuri Shimbun Japan Overview Kyushu University Hospital performed the world's second surgery using ReHeart, an iPS cell-derived regenerative medicine product for severe heart failure. The procedure, conducted on October 27, follows the... -
FDA Gene Editing Guidance: BLA Process and IFS Framework 2026
Pharmaceutical Technology USA Overview The FDA has issued draft guidance allowing Biologics License Applications (BLAs) for individualized genome editing products to add patient-specific variants without new clinical trials. By utilizing... -
Sumitomo Pharma: First iPS-derived Parkinson’s drug transplant
Nikkei Japan Overview Sumitomo Pharma has performed the first clinical transplant of its iPS cell-derived Parkinson's disease treatment, "Amshepri," following its conditional and time-limited approval in March. The procedure was conducte... -
CD73-Targeting CAR-NK Cells: Strategy for Lung Adenocarcinoma
BIOENGINEER.ORG USA Overview Engineered NK-92 cells targeting CD73 demonstrate the ability to destroy relapsed or refractory lung adenocarcinoma cells in preclinical models. By combining direct tumor lysis with the neutralization of aden... -
CAR-T-bridged allo-HSCT: KO-DLI rescue for mixed chimerism
BIOENGINEER.ORG Overview Residual CAR transgene levels at the time of transplantation may signal a risk of persistent CAR-T donor cells causing mixed chimerism with cytopenia. In three cases, CAR-target-knockout donor lymphocyte infusion... -
FDA Personalized Gene Therapy: Draft Guidance for Rare Diseases
BioPharma Dive USA Overview The FDA has proposed a new regulatory framework for personalized gene therapies targeting different mutations within the same disease-causing gene. This "plug and play" approach allows for subsequent mutation ... -
BT-Exo-Pt-miR-196 inhibitor: Bone-targeted exosome specs for osteoporosis
Bioengineer.org USA Overview Engineered M2 macrophage-derived exosomes combined with platinum nanoparticles and a miR-196b inhibitor preserved trabecular bone and reduced osteoclast activity in ovariectomy-induced osteoporosis mouse mode... -
Stealth CAR-Tregs: TRAC deletion for CD3 antibody evasion
bioRxiv France Overview Researchers have developed "Stealth" CAR-Tregs by deleting the T-cell receptor alpha chain (TRAC) to evade depletion by non-mitogenic CD3 antibodies. This strategy shifts the immune balance toward regulation by se... -
iPS Cell Sheet Transplant: First Patient Outcome and Timeline
nippon.com Japan Overview The first patient to receive a transplant of heart muscle cell sheets derived from induced pluripotent stem (iPS) cells is scheduled for discharge this Thursday. The procedure, performed on a woman in her 50s, r...
