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 »
How much promise is there today for stem cell therapy for heart disease? Where do things stand with the clinical research? Patients regularly ask me these kinds of questions. The goal of today’s post is to update you on where things stand. What’s in this post Stem Cell Therapy | Clinical Trials | Delivery of …
Stem cell therapy for heart disease: what you need to know Read More »
The big news of the week was a $3.6 million settlement by a stem cell clinic, StemGenex, and one of its doctors in a class-action suit. I covered this StemGenex settlement and so did Michael Hiltzik of the LA Times and Paul Schloesser at Endpoints. I’d say this was good news for the stem cell field …
Stem cell weekly reads: Jamie Thomson, Lamin B1, CRISPR Read More »
The fact that a person for the first time has received a heart transplant from a pig and it was a genetically modified pig made big news this week. Organ transplant waiting lists are a huge problem so if this kind of approach can be proven to be safe and effective, it would be a …
Recommended reads: pig heart transplant, lasers, $11K pub fee Read More »
Is 2022 going to be any better than 2020 or 2021 when it comes to things in general or for biomedical science? Related to the pandemic? It’s too soon to say but if I had to guess right now I’d venture an optimistic view that overall it’s going to be somewhat better by the end …
Weekly science reads: senescence, alt CRISPR, sickle cell update Read More »
What are your favorite cells? The stem variety? T-cells? I have a hard time choosing just one favorite. The first news item I feature talks new imaging methods to see deep inside any cells. Have a favorite organelle? The secret lives of cells — as never seen before, Nature. This news item covers newer imaging techniques …
Recommended reads: secrets of cells, T-cells, CRISPR Read More »
I’ve been busy recently focusing more on grant and paper writing than reading papers on stem cells, but my piece on trying to de-extinct mammoths via cloning-like methods drew strong opinions on both sides. Recent news and resources on stem cells We’re still awaiting a verdict in the big California federal court case where the FDA is …
Weekly reads: news, legos for stem cells, FDA, cancer, more Read More »
This edition of The Niche weekly reads has a bit more good news than usual including on stem cell transplants. It’s nice to see positive developments like some recipients of hematopoietic stem cell transplants being able to stay at home afterwards. Also, a reminder. You have until July 31 to enter our stem cell video …
The idea of stem cell therapy for diabetes is both exciting and in a way practical. By that I mean that there’s a good common sense foundation here. The idea of stem cell therapy for diabetes What do I mean? If medical researchers can replace lost beta cells in the pancreas using stem cell-produced beta …
Stem cell therapy for diabetes updates: expected IPO, CRISPR, new pubs, more Read More »