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Replimune Faces Major Layoffs Following FDA Rejection
Replimune is cutting 60% of its workforce after an FDA rejection, but vows to continue operations. This move highlights the high stakes of regulatory approvals in biotech.
Serif Secures $50M to Advance DNA Medicine Innovations
Serif, backed by Flagship Pioneering, aims to revolutionize DNA medicine with a fresh $50M investment. This funding could accelerate breakthroughs in gene therapy and beyond.
China’s CRISPR Therapy Challenges US Drugmakers
A new CRISPR therapy from a Chinese biotech firm is poised to challenge US drugmakers, highlighting the competitive landscape in gene editing technologies. This development may prompt CROs to enhance
Vivatides and Life Bio Secure Significant Funding
Vivatides has raised $54 million in a Series A funding round, while Life Bio has attracted $80 million in investments. These fundraising efforts reflect a robust interest in biotech innovations,
China’s Oricell Raises $110M for CAR-T Development
Oricell Biotech has successfully raised $110 million to advance its carcinoma CAR-T therapy plans, with an IPO push on the horizon. This funding round highlights the growing interest in innovative
ADCs
New CAR-T Manufacturing Method Uses Multi-Cytokine Scaffold to Improve T Cell Persistence
EXCERPT: Researchers have published an alternative CAR-T manufacturing approach using a protein scaffold linking IL-7, IL-15, and IL-21. The resulting cells show improved survival, maintained effector function, and self-renewal capacity
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One Pivotal Trial May Be Enough — NEJM Challenges the Two-Trial Dogma
EXCERPT: A New England Journal of Medicine perspective argues that the longstanding expectation of two adequate and well-controlled trials for FDA approval is due for reconsideration, particularly for rare diseases
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WuXi Bio’s Record 2025 Project Intake Was Heavily US-Driven
EXCERPT: WuXi Biologics recorded a record number of new projects in 2025, with US clients accounting for a disproportionate share — a notable data point given the ongoing geopolitical and
Small Molecule
Novartis Announces Fifth US Radioligand Therapy Manufacturing Site in Denton, Texas
EXCERPT: Novartis is building a 46,000-square-foot RLT manufacturing facility in Denton, Texas — its fifth US site and part of a $23 billion domestic investment. Radioligand therapy manufacturing remains one
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FDA Halts RegenxBio Trial After AAV Vector Integration Event Linked to Proto-Oncogene
EXCERPT: REGENXBIO reported a clinical hold following detection of an AAV vector genome integration event associated with overexpression of PLAG1, a proto-oncogene. The finding adds to a growing body of