I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II …
Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags Read More »
An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from …
FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »
When I first started this blog back in 2010 the most contentious issue on the more political side of our field was federal funding for embryonic stem cell research. It was something you couldn’t take for granted. Some history on embryonic stem cell funding in the US There were times back then when funding of …
Is embryonic stem cell research a target after Roe? Read More »
It’s been mostly a downbeat week on the stem cell news front including a deep revisit by Reuters to the Piero Anversa case that has new revelations. It’s ugly stuff involving other folks too. We’ll start on the iPS cell front, where a trial participant had a teratoma. I’ve had a long-standing interest in the …
It’s been a week with a wide variety of regenerative medicine papers and stem cell news. Here’s my earlier take from a few days ago on the Belmonte-led human-monkey chimeric embryo paper in Cell that broke this week. A few days ago I also put up a new video on our Stem Cell YouTube Channel …
Today’s post announces the winner of the 2020 The Screamers Science Hype Award. Since this is the inaugural year for The Screamers, I’m just going to give out one main award: Overall Worst Science Hype. Science Hype Award to FDA Commissioner Stephen Hahn Remarkably, the winner of the overall The Screamers Award for Science Hype …
2020 The Screamers Science Hype Award goes to Stephen Hahn Read More »
As a researcher, is there ever enough time to get to everything that you want to read especially in newer areas like stem cells, organoids, and CRISPR, without even including non-scientific reads like Shakespeare or a new novel or something like that? Hopefully, putting together lists of recommended reads like today’s post is helpful. I …
Weekly reads on organoids, COVID, CRISPR, cold chromatin, more Read More »
Here are some recommended stem cell and other reads for the week ranging from COVID developments to prosecutors finally catching up with a stem cell surgeon who had many patients die to a list of interesting pubs. Because Trump now has COVID, I wondered on Friday if he might consider trying unproven stem cells or …
Recommended reads: Yamanaka review, stem cell indictment, COVID, MYC, more Read More »
The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of …
Politics & FDA OK of 2 stem cell clinic COVID-19 efforts Read More »
Why is former Texas Governor/Trump Energy Secretary Rick Perry plugging unproven stem cells from a clinic firm called Celltex for COVID-19 prevention on Fox News? Perry follows in Giuliani’s footsteps? And more generally, what is it with conservative politicians promoting unproven therapies for COVID-19 and in particular stem cells for the novel coronavirus disease? First, …
Rick Perry plugs Celltex MSCs on Fox for COVID-19 prevention Read More »