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Home » Topics » Drugs » Cell therapy

Cell therapy
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DNA in drug capsules

Alliance for Regenerative Medicine: Field growing, cost still an issue

Jan. 14, 2025
By Nuala Moran
The accelerating pace of U.S. FDA approvals for cell and gene therapies is “great for the field and great news for the patients,” but questions remain over commercialization, with “costs remaining stubbornly high.” That was the glass half-full summary of Tim Hunt, president of the industry group, the Alliance for Regenerative Medicine, reprising progress in 2024, and looking forward to the prospects for further growth and the potential impact of the incoming Trump administration in 2025.
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Stem cells
Neurology/psychiatric

Ips Heart’s stem cell therapy designated orphan drug for Becker muscular dystrophy

Jan. 14, 2025
Ips Heart Inc. has been awarded orphan drug designation by the FDA for its GIVI-MPC stem cell therapy for Becker muscular dystrophy. GIVI-MPC has the unique ability to create new muscle with full length dystrophin in Becker muscular dystrophy.
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Wooden stamp with China flag

China’s NMPA clears country’s first mesenchymal stem cell therapy

Jan. 8, 2025
By Marian (YoonJee) Chu
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
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Early data validate Vir’s newly acquired dual-masked TCE therapies

Jan. 8, 2025
By Jennifer Boggs
Vir Biotechnology Inc.’s 2024 deal with Sanofi SA is starting to look like a pretty savvy move. The company, which picked up three clinical-stage dual-masked T-cell engagers (TCEs) and rights to the platform technology as part of a pipeline overhaul, reported phase I data for TCE programs targeting HER2 and PSMA that indicated promising efficacy with a low prevalence of the cytokine toxicity that has hampered other TCE programs.
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Rendering of hypoimmune cells

Type 1 diabetes breakthrough? Sana threads key ‘islet,’ SC-451 to advance

Jan. 8, 2025
By Randy Osborne
Sana Biotechnology Inc. CEO Steve Harr said “cool and transformative science” led to his firm’s latest strides in type 1 diabetes, and the “very generalizable [clinical] result” cheered Wall Street, which led shares of the Seattle-based firm (NASDAQ:SANA) to close Jan. 8 at $4.30 up $2.65, or 160.6%. “I believe we now have all of the pieces in place to move forward rapidly,” Harr said.
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Wooden stamp with China flag

China’s NMPA clears country’s first mesenchymal stem cell therapy

Jan. 7, 2025
By Marian (YoonJee) Chu
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
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Elderly hands holding broken brain structure
Neurology/psychiatric

Zhongzhi drops $3M in Gabaeron series A for stem cell AD therapy

Jan. 3, 2025
By Marian (YoonJee) Chu
Zhongzhi Pharmaceutical Holdings Ltd. made a $3 million investment in a series A financing round of stem cell therapy developer Gabaeron Inc. Dec. 21, expected to help propel Gabaeron’s preclinical Alzheimer’s disease (AD) candidate into phase I testing.
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Elderly hands holding broken brain structure

Zhongzhi drops $3M in Gabaeron series A for stem cell AD therapy

Dec. 31, 2024
By Marian (YoonJee) Chu
Zhongzhi Pharmaceutical Holdings Ltd. made a $3 million investment in a series A financing round of stem cell therapy developer Gabaeron Inc. Dec. 21, expected to help propel Gabaeron’s preclinical Alzheimer’s disease (AD) candidate into phase I testing.
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Year in review 2024 - Asia deals and innovation

Japan deals big, wins approvals, mulls CGT; Korea, Australia, too

Dec. 31, 2024
By Tamra Sami and Marian (YoonJee) Chu
At Bio Japan 2024, policymakers and industry leaders pledged to make Japan a land of drug discovery to attract native and foreign drug developers. Like many Asian countries, Japan is harnessing and prioritizing the bio sector to drive economic growth, throwing its weight behind its 10-year Bioeconomy initiative to create bioclusters and increase investment.
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3D illustration of mesenchymal stem cells

Mesoblast scores first US nod for mesenchymal stromal cell therapy

Dec. 24, 2024
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), for steroid-refractory acute graft-vs.-host disease (SR-aGvHD) in children 2 months and older, including adolescents.
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