Search Results for: perinatal fda

End of FDA “grace period” impacted perinatal cell therapy biotechs

knot in umbilical cord, perinatal cell therapy

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 …

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FDA warns another perinatal stem cell supplier Stemell

Stemell-logo

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain …

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Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry

Liveyon

The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that  in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry. E. coli and other pathogens ended up in some of the Liveyon product somehow …

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3rd Invitrx warning highlights FDA oversight weakness

The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past …

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Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO

Timothy D. Hunt, new CEO of ARM, Alliance for Regenerative Medicine

I’ve tried to find some time to do some stem cell and other regenerative medicine reading too, but it’s been a busy week of teaching for me as a professor in our new academic year for the UC Davis School of Medicine. I help to teach the Histology part of the first-year curriculum. It’s an …

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Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees

Human-cloning

Cloning is one of those topics that both fascinates and kind of scares people, especially the idea of duplicating people. I regularly cover the topic here on The Niche because stem cell technologies are involved. Also, one form of the process sometimes called “therapeutic cloning” involves embryonic stem cells. Duplicating mammals has now long been …

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Weekly reads: NIH grants, side effect of darker hair, FDA warning, CRISPR

Grant writers handbook, grants cartoon

The last six months I’ve been spending even more time than usual writing NIH grants (and a few others). The last two weeks have been especially busy on this front as I am getting an R01 renewal out the door. My paper reading lately has been mostly related to the grant writing I’m doing. Still, …

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Why did clinic supplier Liveyon halt sales but others kept going despite FDA?

Liveyon-reincarnated

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in …

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FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms

Roya-Panah-Kosolcharoen

Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day …

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