Search Results for: peter marks

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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Highlights of Science Writers DC Stem Cell Panel with FDA’s Peter Marks

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IMG_7988

I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag. I had three wonderful fellow panelists, Marilynn Marchione of

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“Very scary”: Per Marks, RFK Jr. aiming for weaker regs on unproven stem cells

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dr. peter marks fda, cell therapy

How bad could things get with RFK Jr. changing the FDA’s approach to unproven stem cells? I’ve been asking myself this for months since Kennedy’s post that mentioned stem cells on X. New developments suggest things will get much worse. Up until about a week or two ago, my feeling has been that things could

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Striking FDA Hahn & Marks JAMA pub on regenerative clinics

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Dr-Stephen-Hahn-Commissioner-of-FDA

It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other

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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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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 acting CBER director Scott Steele, a biologist & policy wonk who favors nimble oversight?

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Scott Steele

Peter Marks resigned last week as CBER director and now Dr. Scott Steele is the new acting biologics branch director. Marks resigned under pressure and went out firing back, referring to lies and other issues of HHS Secretary RFK Jr. One of the first things I thought when I heard about Marks’ departure was, “who

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

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

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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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Weekly reads: Scott Gottlieb v. RFK Jr., DNA typewriters, Arnold Caplan

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Peter-Marks-Scott-Gottlieb-FDA

Remember former Trump’s FDA Commissioner Scott Gottlieb? Gottlieb’s back in the news in an interesting way related to the upcoming second Trump administration. I just wrote about what to expect from new FDA Commissioner nominee Marty Makary. In that piece, I noted that Scott Gottlieb first came to lead the FDA after a record of

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