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Strengthening Ethical and Professional Practice in Cell and Gene Therapy - Key Highlights from Malaysia’s Updated Guidelines
By Dr. Samuel Ting Chuo Yew President, Sarawak Society for Cell and Gene Therapy Research (SSCTR) The Ministry of Health Malaysia and the National Pharmaceutical Regulatory Agency (NPRA) have recently issued two landmark documents that define the national framework governing the use, research, and regulation of advanced cellular and genetic therapies in Malaysia. These are the “Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs)” publis
Oct 17


Global CGT Landscape: Q2 2025 Report Highlights
Published by ASGCT & Citeline The ASGCT Q2 2025 report shows sustained CGT momentum with new approvals in gene and mRNA therapies, steady deal activity, and rising oncology focus. M&A volume increased sharply, led by major pharma consolidations in advanced therapies. 👉 Read the full report: ASGCT Gene, Cell, & RNA Therapy Landscape Report Q2 2025 Disclaimer Images used are for illustrative purposes only and do not depict actual persons, products, or facilities. For full deta
Oct 15


Novo Nordisk to Acquire Akero Therapeutics for $5.2B
Published on LinkedIn (via Spencer Knight) Novo Nordisk has announced its plan to acquire Akero Therapeutics for up to $5.2 billion,...
Oct 12


Bristol Myers Squibb Acquires Orbital Therapeutics for $1.5B
Published on LinkedIn (via Spencer Knight) Bristol Myers Squibb announced a $1.5 billion acquisition of Orbital Therapeutics, advancing...
Oct 12


FDA Approves INLEXZO™, the First Drug-Releasing System for Bladder Cancer
Published on LinkedIn (via Spencer Knight) The FDA has approved INLEXZO™ (gemcitabine intravesical system) from Johnson & Johnson,...
Oct 12


FDA Issues Draft Guidance on Expedited Programs for Regenerative Medicine
Published on Holland & Knight The FDA has released new draft guidance outlining expedited pathways for regenerative medicine therapies....
Oct 12


Next-Generation CAR T Cells Overcome Solid Tumor Barriers
Published on Technology Networks Researchers at USC Norris and City of Hope engineered CAR T cells that deliver IL-12 fused to a PD-L1...
Oct 4


Experimental Low-Cost Cancer Therapies Challenge Market Models
Published on Bloomberg A new Bloomberg feature examines how experimental low-cost cancer treatments are reshaping debates around drug...
Oct 4


AskBio Begins Phase II Gene Therapy Trial for Parkinson’s in Europe
Published on Bayer Bayer’s AskBio has randomized the first European participants in its Phase II trial of AB-1005, an investigational...
Oct 4


First Parkinson’s Patient Dosed in Pivotal Phase III Cell Therapy Trial
Published on BlueRock Therapeutics BlueRock Therapeutics has treated the first Parkinson’s disease patient in its pivotal Phase III trial...
Oct 4


Scientists Explore New Ways to Reduce Risks in Stem Cell Therapy
Published on Phys.org Researchers are developing strategies to improve the safety of stem cell therapies, focusing on reducing potential...
Oct 4


FDA Issues New Guidance on Cell, Gene, and Regenerative Therapies
Published on RAPS The US FDA has released updated guidance documents covering cell and gene therapies and regenerative medicine. These...
Oct 1


Patient-Derived Dendritic Cell Therapy Targets Hard-to-Treat Cancers
Published on The Scientist Researchers are advancing patient-derived dendritic cell immunotherapy as a personalized cancer treatment. By...
Oct 1


New Insights Into Bone Marrow Stem Cells and Immune Modulation
Published on Stem Cell Research & Therapy A recent study in Stem Cell Research & Therapy explores how bone marrow-derived stem cells...
Oct 1


First-Generation Cell and Gene Therapy Blockbusters: Zolgensma and Yescarta
Published on Alliance for Regenerative Medicine (LinkedIn) Two landmark therapies, Zolgensma and Yescarta, highlight how cell and gene...
Oct 1


FDA Approves First Oral SERD Therapy for Resistant Breast Cancer
Published on LinkedIn (via Spencer Knight) The FDA has approved Inliruqo™ (imlunestrant) from Eli Lilly, the first oral estrogen receptor...
Oct 1


Europe’s Regulatory Shake-Up Raises Concerns for Advanced Therapies
Published on Cytotherapy A new perspective warns that restructuring advanced therapy oversight within the European Medicines Agency could...
Oct 1


Stem Cells May Improve Dialysis Access for Kidney Disease Patients
Published on Mayo Clinic News Network Mayo Clinic researchers report that fat-derived mesenchymal stem cells can help prevent vein...
Oct 1


New Gene Therapy Slows Huntington’s Disease by 75%
Published on Sky News A breakthrough gene therapy called AMT-130 has slowed progression of Huntington’s disease by as much as 75% in a...
Oct 1


Lab-Grown Kidney Assembloids Show Real Function
Published on Drug Target Review USC Stem Cell scientists have created kidney assembloids that function like real organs, combining...
Sep 24
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