I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag. I had three wonderful fellow panelists, Marilynn Marchione of …
Highlights of Science Writers DC Stem Cell Panel with FDA’s Peter Marks Read More »
It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other …
Striking FDA Hahn & Marks JAMA pub on regenerative clinics 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 »
It’s been almost seventeen years that I’ve been a professor here at UC Davis Medical School. It feels like home. I enjoy teaching our first-year medical students each year. Some end up doing research in my lab. Our school recently got a nice write-up over at STAT News by Usha Lee McFarling on the diversity …
Weekly reads: UC Davis Medical School diversity, CRISPR, Parkinson’s 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 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 …
The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways …
One size doesn’t fit all? FDA may soften some cell therapy regs Read More »
The world of stem cell research and regenerative medicine is unpredictable but it’s fun to be a part of it and try to do predictions. Each year in late December or early January I make prognostications for the coming year for stem cell research and regenerative medicine. I made 21 such predictions for the current …
Grading my 21 stem cell & regenerative medicine predictions for 2021 Read More »
Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics …
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 »