If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in […]
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
The idea of stem cells outright curing diseases is exciting and has powerful appeal, but media need to be careful about using the word cure in headlines and articles as we saw this week related to a possible HIV Cure. HIV cure via stem cells and chemo? The big news of the week was that
Weekly reads: possible rare HIV cure, stem cell chicken, FDA commish Read More »
Happy New Year and get ready for another 364 more days of stem cell excitement and craziness in 2022. In the next day or two I’ll post my predictions for this new year. Recommended reads EO Wilson obit by Carl Zimmer in NYT. Who’s the next EO Wilson or someone like him with such big impact these
Weekly stem cell reads: COVID kidney, FDA letter, H3.3, EO Wilson Read More »
If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with
Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs Read More »
Leigh Turner’s new Cell Stem Cell paper on the unproven stem cell clinic industry following up on our collaborative work together in 2015-2016 is great work but very discouraging. He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016. I’m very glad that Leigh has continued this line of
Turner pub charts runaway stem cell clinic industry; FDA needs to think big now Read More »
Any day now we should get the verdict from the judge in the big stem cell clinic case here in California against Cell Surgical Network, et al. It seems that the FDA is waiting on this verdict before taking some major actions. If the judge rules against the agency it could throw the area into
Weekly stem cell reads: pending FDA verdict, blood vessels, RA Read More »
This week marked the release of new draft FDA guidance on cell and gene therapies. Is the FDA kind of like the guidance counselor at school or more like the principal? It probably depends on many factors. I also find it funny how pretty much everyone in academia and biotech industry works to be compliant
Weekly reads: New FDA guidance, brains, MSCs, senescence Read More »
I’ve been busy recently focusing more on grant and paper writing than reading papers on stem cells, but my piece on trying to de-extinct mammoths via cloning-like methods drew strong opinions on both sides. Recent news and resources on stem cells We’re still awaiting a verdict in the big California federal court case where the FDA is
Weekly reads: news, legos for stem cells, FDA, cancer, more Read More »
I recently found concerning SEC filings from the biotech Cryo-Cell about a deal it has with a Duke team for infusions of children with unproven umbilical cord cells. This turns out to be a $58 million deal. It relates in a major way to a Duke compassionate use or expanded access program (EAP) that already had raised
FDA should freeze Duke EAP & probe $58 million Cryo-Cell deal linked to it Read More »