FDA critic Vinay Prasad to run CBER: more politics than experience?

Vinay Prasad, FDA Vinay Prasad

The FDA has a new CBER Director Dr. Vinay Prasad. CBER is the FDA’s biologics branch that handles things like cell therapies and vaccines. The branch has been in near-constant upheaval this year. For a time, Scott Steele was acting CBER Director. It wasn’t clear if he was there in a temporary capacity or would […]

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Weekly reads: pericytes, Nature says don’t rush stem cell OKs, microglia for Alzheimer’s, MYCN

Pericytes

What are pericytes? What about brain pericytes? How are they different than brain parasites? Pericytes on the brain Someone once asked me my favorite type of cell. As a cell biologist, I easily can’t pick just one. It’s like asking a parent to pick their favorite child. However, I will say that pericytes and microglia

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Google’s Gemini AI schools Google Search on its risky stem cell results

Stem cells for autism

Readers of The Niche will probably recall that I’ve been critical of Google Search on stem cells. The search engine giant does unintended promotion of unproven stem cells and the clinics that sell them, like a Ukrainian clinic whose website Google still seems to view as the world’s expert on stem cells for autism, which,

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Weekly reads: stem cell marathon, Ray Therapeutics, stem cells making you fat?

marathon, stem cell

Stem cells can be serious business, but sometimes stories come along that are just fun like a lady running a marathon dressed as a stem cell. How cool is this: “Louise Cato from Somerset is doing the run to raise money for the charity Anthony Nolan, after her dad had a bone marrow transplant over

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Why the FDA & CBER leadership purge will be so bad for biotech

FDA, FDA Trump

The Trump Administration just quickly gutted the FDA including key leadership. What is going to be the impact of this sudden purge? Former Commissioner Robert Califf recently said it is the end of the FDA as we’ve known it. Those are dramatic words, but they seem on the money to me. As a biomedical scientist

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Weekly stem cell reads: tomato stem cells, FDA blacklist, CALEC, odd RFK Jr. summit

stem cell, tomato stem cells

Some of you may know that gardening is one of my hobbies and I see it as akin to science, even like growing stem cell cultures. Tomatoes are my favorite thing to grow. About ten years ago I started sprouting my own tomato plants from seed. It’s surprisingly easy with grow lights. This way you

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Florida stem cell bill is part of state trend to sidestep FDA

Jay Trumbull, Florida stem cell bill

A new Florida stem cell bill directly challenges the FDA and its CBER branch. If passed, which seems relatively likely, the Florida bill would become of state trend.  A Utah stem cell law and a broader Nevada biologics law legally okay non-FDA approved biologics. These and other pending state efforts pose major risks to FDA

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Weekly reads: robot scientist, stem cell sperm make a baby, assembloids & sense

How about a robot grant writing scientist?

What’s life as an academic scientist really like now? It’s gotten worse in the U.S. recently. There’s more stress about funding including on levels that we can’t control. I’m writing too many grant proposals these days. I’m wondering how much researchers are now using AI for grant writing, which I have not done. Does AI

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Calling out colossal baloney on supposed dire wolf de-extinction

dire wolf de-extinction

Just the phrase “dire wolf de-extinction” evokes many things including Game of Thrones. It seems very cool. However, the new claim by biotech Colossal Biosciences that they brought back these unique canines (they were real but are now extinct) seems to me about as real as those giant mythical canines on the TV show. Yet

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New Makary FDA aide Dr. Tracy Hoeg has offered unproven stem cells

New FDA Commissioner Marty Makary has brought on Dr. Tracy Beth Hoeg (or Høeg) as a special assistant. Hoeg has had some controversial views on COVID. She has seemed skeptical of certain elements of vaccination, masking, and school closing. What struck me is that she also has offered unproven cell therapies at a clinic here

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