A new Florida stem cell bill directly challenges the FDA and its CBER branch. If passed, which seems relatively likely, the Florida bill would become of state trend. A Utah stem cell law and a broader Nevada biologics law legally okay non-FDA approved biologics. These and other pending state efforts pose major risks to FDA […]
Florida stem cell bill is part of state trend to sidestep FDA Read More »
What’s life as an academic scientist really like now? It’s gotten worse in the U.S. recently. There’s more stress about funding including on levels that we can’t control. I’m writing too many grant proposals these days. I’m wondering how much researchers are now using AI for grant writing, which I have not done. Does AI
Weekly reads: robot scientist, stem cell sperm make a baby, assembloids & sense Read More »
New FDA Commissioner Marty Makary has brought on Dr. Tracy Beth Hoeg (or Høeg) as a special assistant. Hoeg has had some controversial views on COVID. She has seemed skeptical of certain elements of vaccination, masking, and school closing. What struck me is that she also has offered unproven cell therapies at a clinic here
New Makary FDA aide Dr. Tracy Hoeg has offered unproven stem cells Read More »
I want to discuss a recent development with Humacyte and the FDA, but first, please check out a new video below that is a discussion between student Parmin Sedigh and me on the idea of stem cells for heart disease. Parmin has also written for The Niche and has her own site too. I am impressed
Weekly reads: Humacyte, retinal stem cells, stem cell therapy for knees & hearts Read More »
How bad could things get with RFK Jr. changing the FDA’s approach to unproven stem cells? I’ve been asking myself this for months since Kennedy’s post that mentioned stem cells on X. New developments suggest things will get much worse. Up until about a week or two ago, my feeling has been that things could
“Very scary”: Per Marks, RFK Jr. aiming for weaker regs on unproven stem cells Read More »
Jay Bhattacharya just got confirmed to lead the NIH yesterday. In that role, there are reasons to think he may discourage or even stop some important research and funding. As a stem cell biologist, I’ve been looking out for indications of possible restrictions on our field’s work during the new administration. Bhattacharya’s statements signal potential
NIH Director Jay Bhattacharya could oppose fetal tissue & some stem cell research Read More »
The Japanese stem cell and regenerative medicine oversight system is different than here in the U.S. and in Europe. Japan has had a more permissive approach to overseeing regenerative medicine. While most of the attention has focused on fairly legitimate regenerative biotechs and other sponsors in Japan, there are unproven stem cell clinics there. These
Japanese stem cell clinic oversight: the case of MSC clinic Seijikai Fukuoka Read More »
I had a feeling late last year that I’d frequently be writing about RFK Jr. and his impact on the FDA. However, I didn’t realize some of that would be writing for STAT News. As I mentioned a few days ago, I now have a new regular column over there. I thought the column would
Weekly reads: RFK Jr. stem cell summit, FDA OKs eye cell therapy, cartilage repair Read More »
Sharks are experts at growing new teeth from stem cells. What if we humans could grow new teeth from stem cells too? It seems like a stretch. Compared to sharks, on tooth regrowth we are biological amateurs. While humans and some other animals like dogs have only two sets of teeth in our whole lives,
Reasons to smile at sharks? Growing new teeth from stem cells Read More »
There is growing interest in a possible new reproductive method based on something called in vitro gametogenesis or IVG. Today’s post explains IVG including its potential pros and cons. I also discuss why its possible combination with gene editing is so potentially fraught, which is a big potential con. Let’s start with an explanation of this