A planned change to the Google ads policy will allow some ads for unproven cell and gene therapies. This shift, allowing educational ads, was just announced. I have a few concerns about this change that will start in July. Google ads policy and stem cells This move seems to be a refinement of their “ad ban” policy […]
Google ads policy change to allow unproven cell & gene therapy educational material Read More »
If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
This has been one of those weeks where I spent some time thinking about taking risks in science. How much risk one should take? Risks can come in many forms. It could be at the core level at the bench doing specific experiments and not others. There’s risk in clinical trials, and even in advocacy. Sometimes
Weekly science reads: Macchiarini trial, somites, CRISPR babies 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 »
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 »
Stem cell research relies on some unusual reagents at times including a cell culture product called Matrigel. One of the challenges with such reagents is that if they suddenly are back-ordered it could bring some research to a halt. Matrigel has been in short supply for the last year or so. These products also tend
What is Matrigel, why a shortage, & alternatives? Read More »
What if some legit place like The Mayo Clinic charged people just for the opportunity to talk to a doctor about possibly enrolling in a clinical trial? Imagine this kind of conversation. “Hey, Doc, I have this medical problem and heard you have a relevant clinical trial. Tell me about it.” Then the doctor fills
Mayo Clinic charges patients just to talk about clinical trials? Read More »
The big news of the week was the launch of Altos labs and their ambitious plan to tackle aging through cell therapies. Altos has recruited a large number of top cell biologists away from academia. That team plus top biotech execs and a $3B war chest make Altos one to watch in coming years. I
Weekly reads: aging, CRISPR delivery, hair, oocytes, paralysis Read More »