Potency Rules Firm Up as CGT Scaling Remains the Harder Problem
Two recent pieces look at cell and gene therapy from different angles:
- Quality rules are firming up: FDA's final guidance recommends a risk-based...
Created by David Gonzales
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Two recent pieces look at cell and gene therapy from different angles:
Instead of only seeing a genome's snapshot, the PrinTE simulator starts from an inferred ancestor and evolves forward to the modern genome. In the...
The share surge reflects near-term trial wins. Genmab shares doubled in three months after three successful Phase 3 cancer trials in October, and...
A new CMN Intelligence snapshot counts 356 gene-editing trials as of 30 September 2026.
Americans are shifting from broad multivitamins toward single nutrients, and vitamin D use rose from 5.1% to 29% of adults. But a more targeted choice...
BrightFocus is supporting 182 research grants across Alzheimer's, macular degeneration, and glaucoma, spanning 17 countries.
Mechanical squeezing may help CRISPR reach hidden DNA. Current CRISPR activation converts only a fraction of cells, partly because target sites sit...
The article's headline frames industrialization as a driver of convergent microbiome and host changes. The excerpt is cut off, though, so the...
A target action date is a review deadline, not a verdict. Set under PDUFA, the May 1, 2027 date does not settle the outcome.
FDA's final guidance asks cell and gene therapy developers to show their products meet potency standards through a potency assurance strategy. As CBER...
A $450,000, two-year grant from Swim Across America will support Vanderbilt-Ingram research into a new ovarian cancer approach, running from November...
A brain-controlled approach shows early promise for arm and hand function after cervical spinal cord injury. In a first-in-human study, an implanted...
The field is asking what evidence is needed before microbiome discoveries become useful for diagnosis, prevention and treatment. The 13th World...
Terence W. Friedlander of UCSF explains why he does not save effective drugs for later in advanced renal cell carcinoma. He cites an IMDC analysis in...
RSV is most active in Ohio from November through April, and babies, toddlers, and older adults face the highest risk of severe illness. These everyday...
The article's meristem-nutrition story combines old lab findings with the author's own theory, so it helps to separate them:
Scientists are increasingly examining the digestive system for clues about Parkinson's. A Kerala study comparing 65 patients with 65 mostly...
Charles River spent heavily on its cell and gene therapy CDMO assets, then sold them to GI Partners in early 2026. Peers such as Catalent and...
This roundtable agenda lists questions only and reports no findings, so equivalence between the two routes should not be assumed.
A SHANK3-targeting gene therapy is now enrolling children at three US medical centers, but the macaque research behind it is being cut back.