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FDA shakeup finally gets Nicole Verdun; bros, politics & AI to rule?

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Nichole Verdun, FDA

Someone at the FDA has placed Nicole Verdun, the Super Director of The Office of Therapeutic Products at the agency, and her deputy, Rachael Anatol, on administrative leave as of yesterday. The agency continues to shed key, experienced leadership, most of the departures have been forced. What are Commissioner Marty Makary and newly promoted CBER […]

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Weekly reads: more hype on dire wolves, stemy coin crypto fraud, FDA to rely on AI, vascular organoids

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Fake de-extinction, dire wolves

Despite intense criticism, Colossal Biosciences continues to claim de-extinction of dire wolves. The false claims and hype are such a big mistake. It’s not even necessary either. The firm has a strong scientist in its scientific leader Beth Shapiro. It has George Church. To Colossal, I say that your firm should just say what it

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FDA cell & gene therapy roundtable emphasis on speedy access has huge risks

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FDA Cell & Gene Therapy Roundtable

I had high expectations when I saw the list of speakers for an FDA Cell & Gene Therapy Roundtable held today. Admittedly, earlier when I had seen the meeting announced and no speakers were listed, I wondered how it might go. Would it be like the earlier RFK Jr. regenerative medicine roundtable? That private meeting

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Reading the stem cell tea leaves as Trump FDA warns 2 perinatal biologics firms including Supreme Rejuvenation

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Aracely Cabrera, Supreme Rejuvenation

The FDA’s biologics or CBER branch just warned two perinatal biologics firms. In a way, these letters surprised me more than any in recent years. Up to this point, I had not seen any posted warning letters from the Trump 2.0 FDA to stem cell clinic or biologics supplier-type firms. Part of me thought that

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

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

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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

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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

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

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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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Weekly reads: Topol on longevity biz, Peter Marks out at FDA, timeless NIH grant advice

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Eric Topol, Longevity, Super-Agers

Most of us want longevity, especially if our quality of life remains generally solid as we age. The combination of length and quality of life is sometimes called “healthspan.” How do we get the maximum health span? Easier said than done. Not all of the obstacles are biological either. Unfortunately, accompanying all the legitimate research

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