The Niche

Yesterday was Vinay Prasad’s last day as the Director of CBER, the FDA’s biologics branch and as of today Katherine Szarama is Acting Director. Is there some significance to Szarama being acting director? It’s hard to say. Most signs seem to suggest someone else will become the permanent leader. Katherine Szarama background From Politico: “Szarama […] The post Katherine Szarama, PhD, named Acting…

The last 3 weeks have been extremely busy with grant work, but one recent bit of news that caught my eye was UCB’s $1 billion+ acquisition of Neurona. Neurona has been on my radar screen for years. Neurona and stem cells for epilepsy Here’s the news: UCB pays $650M+ for Neurona, marking ‘strategic expansion’ into […] The post Weekly reads: $1B+ Neurona acquisition, cells + organs = better transp…

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 […] The post Weekly reads: Prasad successor, Sammy Hagar stem cells, more on OSK trial, Finnish spea…

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 […] The post Weekly reads: federal stem cell charges…

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 […] The post Landmark federal indictment for pop peptides alleged ‘scheme’ even…

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 and adults facing brain tumors. Thanks! CIRM-funded therapy gets …

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 was a lot worse for me then. I had just had cancer surgery a few months before starting this website. My progno…

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 embryo models, artificial wombs, and gene editing closely, it was helpful when someone poi…

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 are degrees of thymic regression and loss of function. It reports that r…

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 or Tissues. At least one other person has reportedly died afte…

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 the agency, but so far we’ve mostly just seen chaos. Some like The WSJ felt that Prasad’s decisions were overly strict and inflexible. However, what got me was the chaos and potential role of poli…

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 that point blocked specific peptide compounding due to lack of data and safety concerns. So, what …

There have been more revelations about connections between George Church & Epstein in the past few weeks from the new Epstein files document drop. Church & Epstein I wrote earlier about how Jeffrey Epstein interacted with a team at Harvard/MGH. This included George Church and his colleague at the time Joe Thakuria. There were discussions about doing research on Epstein’s cells. Most of the questi…

Before we dive into the weekly reads, I wanted to explain something new on The Niche and ask for your support of our brain tumor research. Brain tumor research funding As many of you know, some firsthand, funding is extremely difficult to get these days. This is particularly true for NIH funding. Some NIH institutes are only funding 4-5% of applications. Foundations supporting brain tumor researc…

A Lancet paper is sparking excitement about an investigational cell therapy for spina bifida. Here’s the study: Feasibility and safety of cellular therapy for in-utero repair of myelomeningocele (CuRe Trial): a first-in-human, phase 1, single-arm study. Myelomeningocele is the most severe manifestation of spina bifida The work was led by my UC Davis colleagues Diana Farmer and Aijun Wang. The tri…

Longeveron is a biotech studying clinical applications of mesenchymal stromal/stem cells or MSCs . MSCs are interesting, usually heterogeneous cell preparations. They are probably most well known for modulating the behavior of other cells via their secretome. The clinical potential of MSCs is often overstated, typically based on small, uncontrolled trials. So, when randomized, double-blinded, […]…

Several years ago, a stem cell clinic called Seattle Stem Cell Center caught my eye. The Washington State AG’s office filed a case against US Stemology, which appears to have owned the stem cell center. The AG prevailed, but there was another development. A patient named Mike Trujillo died after getting a procedure at the […] The post $24M verdict against Seattle Stem Cell Center clinic in man’s …

The stream of longevity hype can be exhausting, but there’s exciting research in this space too. This week there was some of both. It was also a wild week in the news for the FDA and its CBER branch too. Longevity hype vs. data from new research Can humans reverse aging? Harvard scientist predict revolutionary […] The post Weekly reads: longevity hype vs. cool research, losing your Y, FDA maelstr…

A Japanese panel voted to move 2 iPS cell therapies forward for approval despite there being minimal clinical trial data. Let's discuss the context and potential risks. The post Japan panel OK’s 2 iPS cell therapies despite little data appeared first on The Niche .

When I first read in 2019 that George Church previously had ties to Jeffrey Epstein, I felt disappointed. It’s been fun following Church’s research over the years. I even interviewed him here on The Niche about human germline CRISPR. Now, unfortunately, there are new revelations about Church’s Personal Genome Project (PGP) in the recent Epstein […] The post From skin biopsy to iPS cell proposals:…