Recently I was going through a list I’m updating of regenerative medicine biotech companies including Bluebird bio. Now just a few days later the world seems turned upside down for the firm and maybe to some degree for other companies doing related work. Bluebird bio blues: 2 trial participants get cancer News broke today that […]
Bluebird bio sickle cell gene therapy trial halted on cancer worry Read More »
Here are my recommended weekly reads for The Niche readership for early February 2021 including COVID-19 and stem cell lawsuit updates, papers, and more. How many papers do you end up reading each week or month these days? More or less than before the pandemic? COVID-19 updates New diabetes cases linked to covid-19, WaPo ICYMI
The Niche reads: COVID, new INDs, clinic suits, papers Read More »
I’m not a virologist, but I’m still getting asked these days about what the risks might be from the new generation of RNA vaccines for COVID-19. Approaching this question instead as a biologist and genetics/genomics researcher, I can see a handful of at least hypothetical risks. Below I discuss these possible risks and why I’m
Why I’m planning to get a COVID-19 RNA vaccine: low, mostly theoretical risks Read More »
In my view, it seems likely that the FDA has opened a big can of worms by starting to clear the COVID-19 trials and programs of for-profit stem cell clinics and other related firms. OK to Stemedica trial The FDA just approved another such effort, this one by the firm Stemedica. You can read more about
FDA OK’s more COVID-19 efforts of unproven stem cell clinics Read More »
Many are jumping on the bandwagon of trying stem cells for COVID-19 or testing other cellular therapies for the novel coronavirus disease, but there have been problems with either the rationales for the trials themselves or more often with how they portrayed. Sometimes there has even been outright hype. I’ve called this collective trend of
Overselling stem cells for COVID-19: WSJ article & UMN PR Read More »
The term Regenerative Medicine covers so much biomedical science these days including everything from just about any kind of cell therapy (not just stem cells) to CRISPR gene editing, and with the the COVID-19 pandemic, it seems this umbrella use of the term now includes potential treatment of viral illnesses. It can be hard to
Update on stem cells for COVID-19, Surgisphere scandal Read More »
Meet The Screamers. After being a scientist in one form or another for 30 years and blogging about stem cells and other science for more than 10 years, I’ve seen a lot of science hype. However, some science hype goes above and beyond the usual level to outright smack readers in the face. It almost
Meet The Screamers Science Hype Awards Read More »
The idea of testing stem cells for COVID-19 may be music to the ears of some folks as an opportunity, but to me from the beginning it sounded mostly like a spaghetti on the wall road to trouble. There is buzz out there that some kind of stem cells or other cells will help with
Field throws stem cells for COVID-19 like spaghetti on the wall Read More »
Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day
FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms Read More »
This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm
FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36 Read More »