Updates on Cell & Gene Therapy | Sarawak Society For Cell & Gene Therapy Research (SSCTR)

Double-exposure portrait merging with a brain silhouette, conveying new hope after FDA approval for a rare brain cancer treatment.

FDA Grants Accelerated Approval to Modeyso for Recurrent H3 K27M-Mutant DMG

Published on LinkedIn via Spencer Knight The FDA has given accelerated approval to Jazz Pharmaceuticals’ Modeyso (dordaviprone) for...

CGT Milestones

Aug 8

Parent holding a newborn in soft light, symbolizing early recovery after intranasal stem cell therapy.

Intranasal Stem Cell Therapy Shows Early Promise for Newborn Brain Injury

Published by UMC Utrecht In the PASSIoN safety study at UMC Utrecht, ten newborns with perinatal stroke received a single dose of...

CGT Milestones

Aug 8

Elderly Parkinson’s patient walking through a park with caregiver, symbolizing recovery and independence.

Sumitomo Applies for Approval of iPS Cell Therapy for Parkinson’s Disease

Published in The Japan Times Sumitomo Pharma has applied for regulatory approval in Japan to market a cell therapy that transplants...

CGT Milestones

Aug 7

Diverse patients waiting at a regulatory checkpoint as professionals build a bridge for CGT access.

Global Access to Cell Therapy Requires Regulatory Adaptation and Flexibility

Published on ISCT Telegraft Blog by Francheska Juliano At the ISCT 2024 Annual Meeting in Vancouver, global experts discussed how access...

Regulatory & Compliance

Aug 7

Engineered stem cells releasing growth factors toward regenerating skin, symbolizing ERK-mediated burn healing.

HGH‑Overexpressing Stem Cells Speed Up Burn Wound Healing via ERK Pathway

Published in Regenerative Therapy (Vol. 30, Dec 2025) A study in Regenerative Therapy shows that adipose-derived stem cells (ADSCs)...

CGT Milestones

Aug 7

Woman rises from wheelchair as symbolic donor T-cells surround her, representing CAR‑T success in MS.

Allogeneic CAR‑T Therapy Enables MS Patient to Walk Again in Just 60 Days

Published on LinkedIn via Spencer Knight Jan Janisch-Hanzlik, 49, became the first person in the world to receive allogeneic CAR‑T...

CGT Milestones

Aug 7

AI-powered microscope interface monitoring live stem cells to predict quality via kinetic data.

AI Model Predicts Blood Stem Cell Quality by Tracking Live Cell Behavior

Published by University of Tokyo via Nature Communications Researchers at the University of Tokyo have developed a novel system that...

Educational Insights

Aug 6

Biotech lab hallway narrowing into a regulatory bottleneck labeled "CMC" with queued gene therapy vials behind it.

CMC Hurdles Are Now the Biggest Barrier to CGT Approval

Published on Drug Discovery News Recent FDA rejections of three advanced therapies, Capricor’s CAP‑1002, Ultragenyx’s DTX401, and Rocket...

Regulatory & Compliance

Aug 6

SERB Acquires Y-mAbs Therapeutics in $412M All-Cash Deal

Published on LinkedIn via Spencer Knight SERB Pharmaceuticals will acquire Y-mAbs Therapeutics for $412 million, marking a strategic...

CGT Milestones

Aug 6

Cross-section of bone marrow generating tumor-targeting T cells from engineered stem cells.

UCLA Trial Uses Stem Cells to Create Renewable Cancer‑Fighting T Cells

Published on OncoDaily via Hung Trinh In a first‑in‑human trial led by UCLA, researchers demonstrated that hematopoietic stem cells...

CGT Milestones

Aug 6

Robotic cleanroom performing automated CAR‑T manufacturing steps inside a sealed cell therapy platform.

3‑in‑1 Automated Platform Speeds Up CAR‑T Manufacturing in Just 7 Days

Published by Cytotherapy via LinkedIn A new paper describes a fully integrated platform that automates three core CAR‑T manufacturing...

CGT Milestones

Aug 5

Young girl with hands to her ears as glowing sound waves and DNA strands represent restored hearing.

Gene Therapy Restores Hearing in Teens and Adults with Genetic Deafness

Published on LinkedIn via Spencer Knight In a groundbreaking study by Karolinska Institutet, ten patients born deaf due to a mutation in...

CGT Milestones

Aug 5

Two medication vials on a clinical tray representing FDA approvals for Leqvio and Alhemo.

FDA Approves Leqvio and Expands Alhemo Use in One Day

Published on LinkedIn via Spencer Knight The FDA has granted two approvals within 24 hours. Novartis’s Leqvio (inclisiran), a...

CGT Milestones

Aug 1

Stylized graphic showing cell-based immunotherapy milestone

ARM Highlights Growth and Access Advances in Cell-Based Immuno-Oncology

Published in Alliance for Regenerative Medicine (April 2025 Preview) A new whitepaper from the Alliance for Regenerative Medicine...

CGT Milestones

Jul 29

Smiling patient high-fives hospital staff after completing gene therapy for sickle cell disease.

Casgevy Gene Therapy Brings Relief to Sickle Cell Disease Patient

Published on Mass General Brigham After years of debilitating pain from sickle cell disease, Allan Byamukama became one of the first...

CGT Milestones

Jul 28

Three converging beams representing trispecific antibody targeting cancer cells in advanced myeloma.

AbbVie Acquires Global Rights to ISB 2001 in $700M Deal

Published on LinkedIn via Spencer Knight AbbVie has secured worldwide rights to ISB 2001, a first-in-class trispecific antibody developed...

CGT Milestones

Jul 28

Symbolic handshake over a molecular model and world map representing global biotech licensing between GSK and Hengrui.

GSK Pays $500M Upfront in $12B Deal with Hengrui Pharma

Published on LinkedIn via Spencer Knight GSK has entered a $12 billion licensing deal with China’s Hengrui Pharma, paying $500 million...

CGT Milestones

Jul 28

Lab technicians handling CAR‑T vials with global distribution schematic illustrating scale of AUCATZYL rollout.

Autolus’s AUCATZYL (Obecabtagene Autoleucel) Approved in EU Following U.S. Clearance

Published on Autolus Therapeutics News Releases Autolus’s CAR‑T therapy, AUCATZYL (obecabtagene autoleucel), has received marketing...

CGT Milestones

Jul 27

Layered blueprint and scientific diagram symbolizing healthspan policy reform and regenerative discoveries.

Healthspan Compass Vol. 11 Highlights Breakthroughs in Aging, CAR‑T and Regenerative Science

Published by Regenerative Medicine Foundation The July 2025 Healthspan Compass newsletter showcases several advances in longevity and...

Educational Insights

Jul 27

Invitation to Attend: Workshop on Generative AI for HEOR & Market Access (27–28 August 2025)

Dear Members, I hope this message finds you well. On behalf of the Sarawak Society for Cell and Gene Therapy Research (SSCTR), I am...

President's Desk

Jul 27

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FDA Grants Accelerated Approval to Modeyso for Recurrent H3 K27M-Mutant DMG

Intranasal Stem Cell Therapy Shows Early Promise for Newborn Brain Injury

Sumitomo Applies for Approval of iPS Cell Therapy for Parkinson’s Disease

Global Access to Cell Therapy Requires Regulatory Adaptation and Flexibility

HGH‑Overexpressing Stem Cells Speed Up Burn Wound Healing via ERK Pathway

Allogeneic CAR‑T Therapy Enables MS Patient to Walk Again in Just 60 Days

AI Model Predicts Blood Stem Cell Quality by Tracking Live Cell Behavior

CMC Hurdles Are Now the Biggest Barrier to CGT Approval

SERB Acquires Y-mAbs Therapeutics in $412M All-Cash Deal

UCLA Trial Uses Stem Cells to Create Renewable Cancer‑Fighting T Cells

3‑in‑1 Automated Platform Speeds Up CAR‑T Manufacturing in Just 7 Days

Gene Therapy Restores Hearing in Teens and Adults with Genetic Deafness

FDA Approves Leqvio and Expands Alhemo Use in One Day

ARM Highlights Growth and Access Advances in Cell-Based Immuno-Oncology

Casgevy Gene Therapy Brings Relief to Sickle Cell Disease Patient

AbbVie Acquires Global Rights to ISB 2001 in $700M Deal

GSK Pays $500M Upfront in $12B Deal with Hengrui Pharma

Autolus’s AUCATZYL (Obecabtagene Autoleucel) Approved in EU Following U.S. Clearance

Healthspan Compass Vol. 11 Highlights Breakthroughs in Aging, CAR‑T and Regenerative Science

Invitation to Attend: Workshop on Generative AI for HEOR & Market Access (27–28 August 2025)

Sarawak Society for Cell & Gene Therapy Research

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