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 […]
New Makary FDA aide Dr. Tracy Hoeg has offered unproven stem cells Read More »
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
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
Weekly reads: Topol on longevity biz, Peter Marks out at FDA, timeless NIH grant advice Read More »
How might Trump’s nominee to lead the FDA, Martin Makary, change the agency? Should we be worried or hopeful? I’ve been closely following the FDA and its commissioners ever since I started The Niche in 2010. I’ve been particularly interested in how these leaders impacted FDA actions on cell and gene therapies. How might Makaray
What you need to know about Martin Makary and planning for the Trump 2.0 FDA Read More »
It’s been a long saga for the FDA and the unproven stem cell clinic group called Cell Surgical Network, headquartered in Beverly Hills. A court case involving the two has been unfolding for many years. It has big implications for agency authority and the hundreds of stem cell clinics across the U.S. The case took
I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them
FDA wins big in key federal stem cell clinic court case Read More »
FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I
Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem Read More »
I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah
Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society Read More »
The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,
Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics Read More »
BrainStorm Cell Therapeutics is developing Nurown, an investigational therapy intended for treating ALS. I recently posted about BrainStorm and its prospects for providing real hope on stem cells for ALS. I see it as a long shot. The ALS community needs real hope, but one challenge is determining how good clinical data have to be to
BrainStorm Cell Therapeutics Hail Mary with FDA on Nurown for ALS Read More »