The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024. With […]
FDA warns Frontier Biologics as part of its more active trend Read More »
Remember former Trump’s FDA Commissioner Scott Gottlieb? Gottlieb’s back in the news in an interesting way related to the upcoming second Trump administration. I just wrote about what to expect from new FDA Commissioner nominee Marty Makary. In that piece, I noted that Scott Gottlieb first came to lead the FDA after a record of
Weekly reads: Scott Gottlieb v. RFK Jr., DNA typewriters, Arnold Caplan 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 »
Some recent claims had me wondering whether Liz Parrish is the world’s most genetically modified person. She and her firm BioViva are making that claim. It’s an important question but maybe not for the reason many of us first might think. This is not really about one person. Instead, this is a weighty question because
People often ask me about stem cells for autism or even their hope of an autism cure. I’ve explained that there is no new treatment for autism based on stem cells. There aren’t even mildly encouraging data. Note that it can be hurtful to the community to talk about an autism cure and disregarding neurodiversity.
The biotechs Vertex and CRISPR Therapeutics have an interesting relationship as biotechs. They are partners are multiple levels but also are very different as companies including in size. There’s been a key development in one of their partnerships. Before we jump into that, please check out the video version of my 20 stem cell and
Weekly reads: Vertex & CRISPR Therapeutics, Arnold Caplan death, MS genetics Read More »
Can you paradoxically kill yourself early by trying to cheat Death? For example, die through risky anti-aging approaches? The question came to mind because such longevity efforts have become more extreme. They also get more hype in the media. I’ve been following the anti-aging space mainly because many interventions involve risky stem cell injections. Those
Can trying to cheat death paradoxically kill you sooner? Read More »
Let’s start this week’s digest with a discussion of clonal expansion and mutations during cell and gene therapy development. Here’s the article that brought this to mind. Sickle cell gene therapy process may cause cancer-linked mutations in blood stem cells, Fierce Biotech. Clonal expansion This is a story about a non-CRISPR gene therapy using a
For me, this was another week of heavy grant writing but also taking on Google again. How? Over how badly its search engine often performs on stem cell queries. I have a new piece at MedPage Today. It’s focused on the problem of Google Search promoting unproven stem cell clinic websites. Google still prefers stem
Weekly reads: Google, CIRM, young Swedish bone marrow Read More »
What’s more important than Woolly Mammoth de-extinction research in the stem cell arena? Only maybe a 10,000 other things. Still, the mammoth de-extinction efforts capture people’s attention much more than the average research story. Mammoth De-extinction update Is de-extinction only a pipette dream? This startup has a big, expensive plan to find out, Popular Science.