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
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
More on Church & Epstein, how simple “no” could have been, making amends? Read More »
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
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 trial is
Early encouraging UC Davis trial data on cell therapy for spina bifida Read More »
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
$24M verdict against Seattle Stem Cell Center clinic in man’s death Read More »
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
Weekly reads: longevity hype vs. cool research, losing your Y, FDA maelstrom Read More »
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.
Japan panel OK’s 2 iPS cell therapies despite little data Read More »