Not everything in biomedical science is a ground-breaking discovery or clinical game-changer, but CAR-T cell technology is a combination of both.
CAR-T cell good news
We have such good news in this new pub on long-term benefits: Decade-long leukaemia remissions with persistence of CD4+ CAR T cells, Nature.
Another recent CAR-T cell article, this one in Science, made some news by reporting targeting cardiac fibrosis with CAR-T cells.
And encouraging news locally here with UC Davis becomes first in region to grow cancer-fighting CAR T cells, UC Davis Health.
FDA still without a Commish as Califf confirmation heats up
The FDA is still without a permanent commissioner. President Biden’s nominee is Robert Califf, who previously served as FDA Commissioner during the Obama Administration. The NYT reports on the challenging road ahead for confirmation: F.D.A. Nominee Faces Steep Climb to Senate Confirmation. It’s surprising that this far into an administration that there’s no new commissioner. Could this be contributing to the lack of action by the FDA on stem cell clinics recently even after the grace period for enforcement on such firms ended last May? It’s hard to say but the quietness could have more to do with the still (after 5+ months being on the judge’s desk) unresolved California federal district court case on a chain of stem cell clinics.
Recommended reads
- A lymphatic-stem cell interactome regulates intestinal stem cell activity, bioRxiv preprint.
- An oncogenic enhancer encodes selective selenium dependency in AML, Cell Stem Cell.
- Macrophages transfer mitochondria to sensory neurons to resolve inflammatory pain, Neuron. Is there anything that cells cannot pass along to their neighbors? Entire nuclei in a sense can go via fusion in rare cases. Complicating the lives of scientists, cells can also pass along molecules too like fluorescent proteins like GFP, Cre recombinase, and other molecular tools.
- SoxD genes are required for adult neural stem cell activation, Cell Reports.
- In vivo CRISPR screening identifies BAZ2 chromatin remodelers as druggable regulators of mammalian liver regeneration, Cell Stem Cell.
- FDA slams clinical hold on LogicBio’s gene editing drug after clotting cases in child patients, Endpoints.
- CDK19 regulates the proliferation of hematopoietic stem cells and acute myeloid leukemia cells by suppressing p53-mediated transcription of p21, Leukemia.
- Cone photoreceptors in human stem cell-derived retinal organoids demonstrate intrinsic light responses that mimic those of primate fovea, Cell Stem Cell. Can you see me now? This reminds me of the work producing primitive eye-like structures in brain organoids.
The FDA needs leadership that is independent of the very industries it is supposed to be regulating. Califf is not that sort of leader. We need a public servant along the lines of at least a USPHS Commissioned Officer. There needs to be a far greater adversarial relationship between Big Pharma and the FDA. The Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) are not the prescriptions for that sort of relationship. Big pharma is more of a client of the FDA lately. Califf, like all the other FDA Commissioners from the 90’s on, has simply worked within that corrupt FDA Big Pharma Relationship. We need a better public servant who will take on that corrupt relationship and deep six it and not advocate for it. Bernie Sanders has been absolutely correct in opposing Califf (twice) upon being selected/confirmed to lead the FDA.