Last chance to register! Join us Wednesday in DC or virtually for our "Unlocking Next-Generation Therapies" meeting: https://t.co/TJJgGfkPqy. This free event will bring together experts across industries to explore innovative approaches in cell therapy development.
The recent AMT-130 topline results and the ensuing regulatory debate around a potential marketing application have quickly become one of the most closely watched developments. Here are some of my thoughts on the current data…
https://t.co/K5wki4cQB2
@adamfeuerstein BBWs are typically issued when risk is clear, repeatable, and not meaningfully mitigable. Although the case is mechanistically reasonable, this single reversible case (per PRnews) is likely insufficient to trigger BBW. Likely requests long-term malignancy surveillance commitment.
this immune-related DILI in CRISPR trials could become a controllable variable rather than a showstopper, as we saw in AAV trials. The liver remains biology’s most honest reviewer — and CRISPR is learning its hard lesson in humility and translation.
and together they could trigger immune-mediated hepatocellular injury. It’s still early to conclude this is a platform failure or a calibration moment. With early risk screening, short steroid bridges, and dense liver monitoring,
There’s something profoundly satisfying about a Kaplan–Meier curve that’s completely flat—it’s the quiet signature of rigorous science and relentless work.
FDA’s CNPV pilot program redefines what priority means. The first 9 recipients reflect a shift from purely clinical innovation to national impact, manufacturing resilience, and affordability. https://t.co/9FlKUJYpKa