It’s been mostly a downbeat week on the stem cell news front including a deep revisit by Reuters to the Piero Anversa case that has new revelations. It’s ugly stuff involving other folks too. We’ll start on the iPS cell front, where a trial participant had a teratoma. I’ve had a long-standing interest in the …
Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come …
What is an FDA warning letter & how should firms respond Read More »
We often don’t think of them that way but reproductive cells like sperm and egg are also relatives of stem cells, and it turns out that there are stem cells that make the reproductive cells too like sperm stem cells. Sperm and germ cell stem cells DNMT3A-dependent DNA methylation is required for spermatogonial stem cells …
Recommend reads: CRISPR baby guy free, DNMT3, sperm, Editas, hearing loss, reprogramming Read More »
At the beginning of the year I wrote about a new kind of biotech called Altos Labs. It’s very different in some ways from other institutions. I find it an intriguing research entity. Where do things stand now with Altos Labs a few months later? More information, new ideas, and questions have popped up in the …
Many firms that generally fall into the category of unproven stem cell or cell therapy clinics have a way of reinventing themselves and I’ve seen this with one formerly named the Lung Institute that is now called Centers for Respiratory Health. First the Lung Institute became the Lung Health Institute. Now that firm has become …
Centers for Respiratory Health is new incarnation of clinic Lung Health Institute Read More »
It’s very challenging to be an academic scientist even under normal circumstances so when a government starts going after researchers for things like supposed irregularities in funding disclosures, it can cause serious problems if not carefully overseen. We’ll start this week’s recommended reads with the feds monitoring such disclosures and even making referrals to the …
Weekly reads: Yale scientist suspended, WA AG sues clinic, new pubs 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 »
Before starting the umbilical cord cell supplier and marketing firm Liveyon, John Kosolcharoen was involved in some alleged health care fraud. The feds brought a case against him related to prescription drugs. Older case coming to a head As Liveyon was having its misadventures in the stem cell clinic sphere, the status of that past …
Feds want $3M, prison for Liveyon founder in old fraud case Read More »
What exactly is a mesenchymal cell and what does the acronym MSC stand for these days? I took a stab recently at discussing mesenchymal cells and the MSC acronym so check that out. There is a great need for standards on MSCs and the products out there being marketed as MSCs are probably in reality …
Weekly reads: MSC, p53, EuroGCT, fake fish, K27M CAR-T Read More »
I’ve ended up learning a lot about multiple sclerosis (MS) while writing The Niche for the past twelve plus years, but I’ve never seen anything like the new research linking EBV and MS. EBV stands for Epstein Barr Virus. The reason I’ve learned much more about MS while writing here is that there has been …
Stronger link between EBV and MS brings concrete clinical hope Read More »