Search Results for: fda

Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees

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Human-cloning

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 […]

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Weekly reads: NIH grants, side effect of darker hair, FDA warning, CRISPR

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Grant writers handbook, grants cartoon

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,

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Weekly reads: Jan Nolta recognition, new director after Irv, FDA guidance

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Dr. Jan Nolta UC Davis

People are the real driving force in the stem cell and regenerative medicine field including my colleague Jan Nolta here at UC Davis. She is the Director of our Stem Cell Program. There’s also news about Stanford’s stem cell Director Irv Weissman. Jan Nolta receives award Jan’s lab is prolific and in many ways is

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One size doesn’t fit all? FDA may soften some cell therapy regs

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dr. peter marks fda, cell therapy

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

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End of FDA “grace period” impacted perinatal cell therapy biotechs

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knot in umbilical cord, perinatal cell therapy

If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in

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FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

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FDA

The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical

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Weekly reads: possible rare HIV cure, stem cell chicken, FDA commish

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HIV infected T cell, HIV cure

The idea of stem cells outright curing diseases is exciting and has powerful appeal, but media need to be careful about using the word cure in headlines and articles as we saw this week related to a possible HIV Cure. HIV cure via stem cells and chemo? The big news of the week was that

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Weekly stem cell reads: COVID kidney, FDA letter, H3.3, EO Wilson

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EO Wilson

Happy New Year and get ready for another 364 more days of stem cell excitement and craziness in 2022. In the next day or two I’ll post my predictions for this new year. Recommended reads EO Wilson obit by Carl Zimmer in NYT. Who’s the next EO Wilson or someone like him with such big impact these

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