Imagine regularly having someone rub your face all over with the equivalent of a small roller covered with spikes and doused with either your blood or someone else’s and you have what’s called vampire facials. There’s more news that this is a very bad idea. Vampire facials linked to more HIV cases “Vampire facials” promoted […]
Weekly reads: HIV from vampire facials, CAR-T, FDA warns Regenative Labs Read More »
It’s a big challenge to get a cell therapy approved by the FDA and if you look at my list of FDA-approved stem cell therapies, it’s not as long as we might hope. FDA OK on cell therapy from Gamida Cell For this reason, it was excellent news to see that the FDA approved a
Weekly reads: FDA nod on new cell therapy, gray hair, pong-playing cells Read More »
The biotech Sarepta has had a complicated go of it with the FDA sometimes related to their Duchenne muscular dystrophy (DMD) gene therapy efforts. In late 2016 I wrote about how there was some controversy as the FDA approved the Sarepta drug eteplirsen (Exondys 51) also for DMD, going against an advisory panel that had
Weekly reads: Sarepta, epigenomics, FDA on eyedrops Read More »
The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past
3rd Invitrx warning highlights FDA oversight weakness Read More »
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 »