Readers of The Niche have asked me many questions about stem cells for autoimmune disease but the puzzle of why women get these conditions more often than men hasn’t come up before here. For instance, why is MS so much more common in women than men? It’s remained somewhat of a mystery over the years. …
Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter …
Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial Read More »
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 »
I’m trying to remember the first time I ever heard about clones. It had to be as a kid. Maybe in a monster movie or TV show? Possibly a clone was referred to by the more general term “double”, which is not necessarily a clone. Whatever it was, I’m sure as a kid that I …
Weekly reads: game of clones, super-SOX, Moonwalk Bio, Great Wall’s living skin Read More »
The FDA has a unique mechanism called RMAT or regenerative medicine advanced therapy designation. It’s intended to move investigational regenerative therapies forward more effectively. RMAT data I recently updated The Niche RMAT list and it has jumped to 85. The FDA has approved many new RMATs this year. The data on how many applications the FDA …
The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for …
For about as long as I’ve been writing The Niche, people have been asking about stem cells for MS. There’s a huge need for new therapies. While a chemo-based approach with autologous hematopoietic stem cell transplantation (HSCT) looks to work for certain cases of multiple sclerosis (although not yet approved in the US), other cell …
Weekly reads: stem cells for MS, good news x2, extending dog years, Neuralink updates 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 …
Some folks can view data from early, small clinical trials too skeptically or overly enthusiastically, and maybe that’s going on with some preliminary results from Verve Therapeutics. Good news? Bad news? I’m going to start with two articles about the same news that have very different vibes. What do I think? On the whole, I …
Weekly reads: Verve Therapeutics, Casgevy UK OK, GDNF, MYC Read More »
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 »