Even during the holidays, I keep looking over all the latest research and news on regenerative medicine, including recently related to a firm called Unlimited Bio. The umbrella term “regenerative medicine” includes gene therapies and gene editing. The field is seeing non-traditional trials of regenerative medicine-related technologies including genetic approaches for enhancement. Sometimes the same […]
State attorneys general have done a good job addressing the stem cell clinic problem locally. They’ve increasingly taken action on unproven stem cells and related firms. In some ways, they’ve been more effective than the feds. The AG successes have been particularly important given the uneven activity from the FDA and FTC. Iowa AG wins
Iowa AG wins $1M from stem cell clinic Read More »
I had expected that there would be criminal charges related to stem cell clinics this year, but admittedly I didn’t see it coming in Utah. This was one of my 25 stem cell predictions for 2025. The stem cell clinic world has so much that is problematic. Where does something cross the line from perhaps
Felony charges against 3 in Utah related to stem cells, undercover agents visited clinic Read More »
When I was talking with my mom the other day, she asked me about how things are going with stem cells for vision loss. Fortunately, her vision remains fine, but we both know people dealing with macular degeneration. Fortunately, there’s some more hopeful news in this space so let’s start there. Then we’ll get to
RFK Jr. posted last year about wanting to weaken FDA oversight of both stem cells and peptides. What we mean by peptides here is a class of unproven and non-FDA-approved drugs sold by wellness influencers. Compounding pharmacies have made such wellness peptides available in the past before the FDA rightly became more restrictive about their
GOP lawmakers ask RFK Jr. to make FDA unleash risky peptides like BPC-157 Read More »
Three recent FDA warning letters, including one issued to publicly-traded Celularity, paint a helpful picture of where FDA oversight stands. They illustrate how the FDA’s classification of placental/amniotic products greatly depends on how a firm positions a product clinically. The marketing is key. Comparing these warnings three letters offers a useful window into current and
Celularity & 2 other perinatal biologics firms get FDA warnings Read More »
I’ve followed an anonymous blogger called DrugMonkey over the years for helpful insights into the NIH grant process. DrugMonkey on NIH grant changes If I ever knew, I forgot their real name. Whoever they are, the blog has some NIH funding wisdom. Here’s an important new piece from that blog on how the Investigator component
The FDA just announced it approved the cell therapy Omisirge from Gamida Cell for severe aplastic anemia (SAA). This is the first cell therapy approved for SAA. SAA is a rare, life-threatening blood disorder. It is often treated with hematopoietic stem cell transplants or immunosuppression. There’s a major autoimmune component to the condition. The FDA
It seems like some multibillionaires either want to live forever or make more money by investing in longevity firms, or both, and that rings true again with Sam Altman’s $100M-plus bet on Retro Bio. Before we get to that, I wanted to mention that Tracy Hoeg, a top aide to Marty Makary, has been named
Weekly reads: Sam Altman Retro Bio anti-aging, skin organoids, more FDA turmoil Read More »
The cell therapy biotech Capricor just released new Phase 3 data from its Duchenne Muscular Dystrophy (DMD) program The firm is trialing its stromal cell product deramiocel for DMD. These new results are very encouraging and stronger than past data. Why am I excited here? These newest deramiocel results released in a PR show statistically
Could Capricor’s report of strong data on deramiocel for Duchenne spark FDA approval? Read More »