I’ve written before about concerns related to longevity research hype from Harvard professor David Sinclair. The media often eats up statements about longevity from Sinclair and a few other scientists in that space. There is also endless coverage of the latest exploits of wealthy health influencer Bryan Johnson. For that reason it was refreshing to […]
Refreshing WSJ piece on longevity ‘guru’ David Sinclair Read More »
How might Trump’s nominee to lead the FDA, Martin Makary, change the agency? Should we be worried or hopeful? I’ve been closely following the FDA and its commissioners ever since I started The Niche in 2010. I’ve been particularly interested in how these leaders impacted FDA actions on cell and gene therapies. How might Makaray
What you need to know about Martin Makary and planning for the Trump 2.0 FDA Read More »
Remember cryonics, the idea that you could hit pause on human life? This relies on the super-cold power of liquid nitrogen or some other ultra-freezing method. Apparently cryonics is still a thing and there are people with even just their heads frozen. A new story claims a different way to hit the pause button on
Weekly reads: hit pause on human life, CIRM pause, 23andMe data, blast from the past Read More »
This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve
Big spike in FDA warning letters to unproven biologics firms Read More »
If only humans could master regeneration. It seems like that would open the door to far better health. Maybe to longer life too. We can see how many other creatures innately can regenerate organs. I can see it in the lizards that run around in my garden. Every now and then I see one with
Gene editing continues to advance both in the clinic trial arena and at more basic science levels including a report on a new approach called click editing. The two gene editing papers below highlight the variety of tools now available. Gene Editing papers including click editing Click editing enables programmable genome writing using DNA polymerases
Recommended reads: click editing, CRISPR v. progeria, diapause transcriptional program Read More »
Nevada has a relatively new 2023 law legalizing non-FDA-approved biological and gene therapies. I use the word “therapies” here loosely. They are not scientifically or medically proven to work or be safe so they could lead to substantial harm. This is yet another early step in a likely growing trend of states challenging FDA authority
Mesenchymal stromal/stem cells or MSCs are widely used by unproven clinics, but MSC research also suggests real promise in specific areas. Clinics mainly use adipose MSCs (often called SVF) or bone marrow MSCs. However, umbilical cord MSC preparations are getting more popular too. Many questions swirl around the use of MSCs including what exactly are
Combinations of human flesh and robots are more in the news lately. Sometimes the fleshy parts are grown from stem cells in a lab. Robots with fleshy faces Scientists in Japan Give Robots a Fleshy Face and a Smile, NYT. I’m working on a piece about robots in China with small, human brain-like structures. Stay tuned
Recommended reads: flesh-faced robots, ALS, Spina Bifida,neuronal CRISPR Read More »
When I was first really getting into stem cells as a trainee the name Catherine Verfaillie came up as a scientist to watch in the adult stem cell area. It wasn’t too long after that though that I started hearing that some of the work from her lab at the University of Minnesota was being
Recommended reads: Nature Catherine Verfaillie retraction, Horvath paper, Vertex Read More »