FDA Withdraws Approval for Chikungunya Vaccine
Summary:
The FDA has pulled the biologics license for Valneva’s Ixchiq chikungunya vaccine amid serious safety concerns, and an effort is now underway to recall a key safety and efficacy study for the antidepressant Paxil.
CRISPR-Based Gene Editing Set to Surge to $24.37 Billion by 2034
Summary:
According to Nova One Advisor, the CRISPR-based gene-editing market is poised to surge from approximately USD 7.06 billion in 2025 to a striking USD 24.37 billion by 2034, demonstrating robust growth at a CAGR of about 14.76%. Driving this expansion are CRISPR’s unmatched precision, high efficiency, and versatility – making it a standout technology over older gene-editing methods like ZFNs and TALENs.
FDA Extends Review Timeline for REGENXBIO’s MPS II Gene Therapy, RGX-121
Summary:
The FDA has pushed back the PDUFA target date for Regenxbio’s one-time gene therapy for Hunter syndrome, RGX-121 (clemidsogene lanparvovec), from November 9, 2025 to February 8, 2026, following the submission of longer-term clinical data for all 13 trial participants.
How Quantum Tech Is Redefining the Future of Pharma
Summary:
Quantum computing is set to transform pharmaceutical R&D, with McKinsey estimating it could unlock $200 billion to $500 billion in value by 2035. By enabling molecular simulations from first principles, this technology promises faster, smarter, and more precise breakthroughs in drug discovery, target validation, and even clinical trial optimization.
World’s First Pig-to-Human Lung Transplant Marks Milestone in Xenotransplantation
Summary:
In a groundbreaking first, Chinese surgeons transplanted a gene-edited pig lung into a brain-dead human, marking a bold milestone in xenotransplantation and keeping the organ functional for nine days. Though early inflammation and immune rejection emerged within 24 hours, the experiment – published in Nature Medicine – offers a promising but cautious path toward addressing global donor lung shortages.
