A University of California Berkeley team reported a protein engineering strategy that increases Cas9 nuclear import by inserting additional nuclear localization signals into surface loops, improving gene editing efficiency in human T cells. The approach avoids the expression problems seen when adding long terminal NLS tails and could enhance clinical gene‑editing yields. Separately, academics and biotechs released detailed FDA interactions related to the bespoke gene therapy used in the Baby KJ CRISPR case, offering procedural guidance as regulators consider a streamlined pathway for individualized genetic medicines. The materials clarify pre‑submission expectations, safety data priorities and regulatory touchpoints for one‑off therapies. Together these reports couple technical improvements in gene‑editor delivery with a clearer regulatory route for bespoke CRISPR interventions—an intersection that may accelerate localized, patient‑specific gene therapy development.
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