Vinay Prasad has only less than two weeks left at the FDA atop CBER. I’ve been trying to imagine where CBER goes from here after he exits. It feels like FDA Commissioner Marty Makary and RFK Jr. will likely be the real leaders of CBER moving forward on key decisions. Under that pressure, will the […]
Over the years people have asked me why those selling unproven stem cells and more recently peptides haven’t faced more pushback. Cases do arise, but they often go nowhere. Civil cases like patient lawsuits against stem cell clinics are often settled. These are generally subject to confidentiality agreements. On the peptide front, we’ll have to
It’s been a whirlwind of news about pop peptides like BPC-157 and now one of the first indictments related to marketing of these unproven drugs at a clinic. While RFK Jr. may want to unleash previously banned peptides on the public, it hasn’t happened yet. Those still selling these unproven peptides anyway have had to
We recently saw exciting news with the first CIRM-funded therapy garnering FDA approval. Before we jump into that and other news and new publications, a reminder that my lab is still crowdfunding to support our brain tumor research in these tough funding times. Please consider making a tax-deductible gift to give more hope for kids
I love science pictures. Even when I was a kid, images of science really struck me. I’ve been doing The Niche now for 16 years and come across many unusual pictures during that time. It’s hard to imagine that I started this site in 2010. What a different world that was. In some ways, it
You’ve probably heard of the film Gattaca, but what is a Gattaca stack? The first thing that came to mind was a peptide stack (oh no!). That is where people take groups of unproven peptides together, usually by injection. Yeah, not a great idea. So, what’s the Gattaca stack? As someone following the area of
Connections between the thymus and aging are growing. Let’s start with that interesting area of research. The thymus and aging In Histology class at the med school here we teach that the thymus just naturally involutes. It mostly turns to adipose tissue with age, which is a depressing thought. A new paper suggests that there
Weekly reads: the thymus and aging, Aspen upbeat 1 year data, paired organoids Read More »
The FDA is reporting that someone in the US died after use of a regenerative medicine product imported from Japan called Laennec. Here’s the FDA report on the death related to Laennec. The agency advisory is titled: Patient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells
Vinay Prasad, the outgoing CBER Director (right), with Commissioner Marty Makary, at a cell and gene therapy roundtable last year. Vinay Prasad is leaving the FDA again in a few weeks. As CBER Director, Prasad was all over the place on how he handled oversight of biologics. He and Commissioner Marty Makary promised flexibility from
RFK Jr. might be the biggest peptides fan of all. Or it could be the compounding pharmacy industry or Joe Rogan. For a few years, compounders were profiting from marketing the most popular of these unproven peptide drugs (what I call “pop peptides”). The FDA put a halt to that in 2023. The agency at