biotechs

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

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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Mayo Clinic charges patients just to talk about clinical trials?

The Mayo Clinic.

What if some legit place like The Mayo Clinic charged people just for the opportunity to talk to a doctor about possibly enrolling in a clinical trial? Imagine this kind of conversation. “Hey, Doc, I have this medical problem and heard you have a relevant clinical trial. Tell me about it.” Then the doctor fills …

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All about Altos Labs & its $3B cellular rejuvenation push

Altos Labs PIs

I wrote briefly a few months ago about Altos Labs. It’s a new kind of biotech institute that is focused on cellular reprogramming. My original piece was sparked in part by an article around the same time by Antonio Regalado over at MIT Tech Review. He provided some tantalizing details on Altos. Also, I had heard some …

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Bluebird bio sickle cell gene therapy trial halted on cancer worry

bluebird bio, sickle cell gene therapy

Recently I was going through a list I’m updating of regenerative medicine biotech companies including Bluebird bio. Now just a few days later the world seems turned upside down for the firm and maybe to some degree for other companies doing related work. Bluebird bio blues: 2 trial participants get cancer News broke today that …

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Mesoblast MSCs Quell Peds GvHD; On Road to FDA Approval?

MSCs-mesenchymal-stem-cells-stromal-cells-small

Graft-versus-host disease (GVHD) is counterintuitive In the weeks and months following a transplant, a major concern is the recipient’s immune system rejecting the “foreign” biological material. But in GVHD, the opposite happens: transplanted tissue unleashes a horde of T cells that spark a cascade of inflammation, within 100 days. Typically, GVHD follows a bone marrow …

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Recommended reads: COVID-19 updates, FDA stem cell nod, PRC2, more

Fig.-3d-Rai-et-al-Nature-Communications-2020

Today’s post is the latest edition of my weekly recommended reads, which this week include Fate Therapeutics, COVID-19 updates, AAMC, and more including some great pubs such as one on 2 modes of PRC2 function. Also check out this handy resource: Helpful 2020 List of Stem Cell Journals and this blast from the past post of 10 …

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New Mesoblast “COVID kid” stem cell study

Dr-Fred-Grossman-CMO-Mesoblast.

The biotech Mesoblast is starting an expanded access study of its stem cell product for kids with a severe offshoot of COVID-19. The cellular drug in this case is remestemcel-L (more below). While most children fare better than adults in dealing with COVID-19, the rare subset of kids with COVID-19 for this study have more severe …

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Just one word placentas: Can Celularity live up to hype?

Celularity-e1519061558939

I’ve been blogging about stem cells now for about 8 years and the recent level of hype about and fluffy media coverage of Celularity, the biotech spun out of Celgene, ranks right up here with the most extreme past cases I’ve seen. What is Celularity and who is its leadership? It’s a new biotech focused …

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Stem cells for the flu? Pondering PR email, frailty data from Longeveron

Tompkins-Figure-2A

Stem cells for flu? For me, that idea is new. Some months back there was buzz about the stem cell biotech Longeveron related to its report on early trial data on testing infusions of mesenchymal stem cells for frailty in the aged. Frailty that pops up in some aging folks can manifest in a variety …

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ViaCyte Interview on Diabetes Stem Cell Trials & Cool Role of Gore-Tex Tech

ViaCyte

When I think of the promise of stem cells for diabetes, the privately held California stem cell firm ViaCyte is the first biotech that comes to mind now. It has promising stem cell clinical trial work building. Today’s post is a new interview with the company’s CEO Paul Laikind. For past posts on ViaCyte see here, which …

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