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 »
The FDA has finally filed an appeal of the Cell Surgical Network lawsuit verdict. It took them a very long time for some reason. The stem cell clinic chain Cell Surgical Network and other defendants had prevailed in a federal district court here in California in front of Judge Jesus Bernal. Their adipose cell product, stromal …
FDA appeals Cell Surgical Network lawsuit verdict 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 »
The big news of the week was the big FDA stem cell in court by Judge Jesus Bernal here in California, who ruled in favor of a chain of stem cell clinics called Cell Surgical Network. The FDA had been seeking an injunction against the clinics. I believe the ruling was founded in part on …
Weekly reads: CRISPR, FDA stem cell loss, pioneering AMD study, MS, Verve Therapeutics Read More »
In a ruling that could turn FDA stem cell clinic oversight on its head, Federal District Court Judge Jesus Bernal last night ruled in favor of the stem cell clinic chain Cell Surgical Network and other defendants. The FDA had been seeking permanent injunction against them. Here’s the court ruling. Drs. Mark Berman and Elliot …
Judge drops a bomb on FDA in Cell Surgical Network stem cell clinic case Read More »
I’ve tried to find some time to do some stem cell and other regenerative medicine reading too, but it’s been a busy week of teaching for me as a professor in our new academic year for the UC Davis School of Medicine. I help to teach the Histology part of the first-year curriculum. It’s an …
Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO Read More »
Cloning is one of those topics that both fascinates and kind of scares people, especially the idea of duplicating people. I regularly cover the topic here on The Niche because stem cell technologies are involved. Also, one form of the process sometimes called “therapeutic cloning” involves embryonic stem cells. Duplicating mammals has now long been …
Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees Read More »
The last six months I’ve been spending even more time than usual writing NIH grants (and a few others). The last two weeks have been especially busy on this front as I am getting an R01 renewal out the door. My paper reading lately has been mostly related to the grant writing I’m doing. Still, …
Weekly reads: NIH grants, side effect of darker hair, FDA warning, CRISPR Read More »
The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year. It’s been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven …
Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come …
What is an FDA warning letter & how should firms respond Read More »