Search Results for: predictions

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: CBER changes, Parkinson’s, 2-dad mice, NIH woes continue

dr. peter marks, cell therapy

I recently looked at the organizational chart at the FDA’s Center for Biologics Evaluation and Research or CBER. Why? I have been anticipating some possible big changes there with the new administration. After all, with HHS Secretary RFK Jr. having previously claimed that the FDA was suppressing various unproven things including at least two kinds

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Initial reactions to RFK Jr. being HHS Secretary

RFK Jr.

There were many reasons for the U.S. Senate not to confirm RFK Jr. as HHS Secretary. Reasons that transcended politics. Nonetheless, Senate Republicans confirmed him today for that post. Some of them had voiced serious concerns before including one physician Senator, Dr. Bill Cassidy, but they all voted for Kennedy anyway. All except Mitch McConnell,

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Tech Bro Manifestos, AI, and the Future of Biology (& Stem Cells)

Tech Bro Manifestos

How seriously should we take tech bro manifestos? Also, what do the tech bros — the billionaires and centimillionaires who made their fortunes founding, running, or investing in tech companies — have to say specifically about the future of biology including regenerative medicine and stem cell research related to AI? A fair bit, as it

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Weekly reads: FDA modernization, TFs on the brain, mortality timer, pluripotent trials

FDA

How will things change at the FDA under the second Trump Administration? It’s a key question for our field but not easy to answer. Most likely there will be more instability at the agency. Some leaders, like of CDER, have already left. in my overall regenerative medicine predictions for 2025, I’ve included more predictions about

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Weekly reads: stem cell therapies that work, exosomes, H3.3 K27M, Joe Rogan

stem cell therapy

How close are we to having new stem cell therapies that work? The field is nearly there on several fronts, but we shouldn’t get ahead of ourselves. Last week I noted the “soon” in a Nature News headline “Stem cells head to the clinic: treatments for cancer, diabetes and Parkinson’s disease could soon be here.”

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In landmark, FDA approves first MSC therapy, Mesoblast’s Ryoncil for GvHD

mesoblast ceo dr silvio itescu

In a landmark decision, today the FDA approved Ryoncil from Mesoblast for GvHD. This is the first time the FDA has approved a mescenchymal stromal/stem cell or MSC therapy of any kind. There have been many ups and downs for Mesoblast toward this approval of Ryoncil or remestemcel-L, an allogeneic marrow MSC product. See my

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Positive regenerative medicine story of the year: diabetes & sickle cell were tops

regenerative medicine

What was the biggest upbeat regenerative medicine story of 2024? I have my own favorites but decided to run a poll. Just putting the poll together, it was evident that this year was unusually full of good and encouraging news. Diabetes and sickle cell regenerative medicine therapies In The Niche polling, so far Vertex Type

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