What does an FDA warning really mean? Why historically in some years has the FDA issue no warnings related to biologics, while in other years it issues many? Some of it likely reflects the philosophy of the agency leadership. Of course, another factor is how much activity there is that the FDA sees as non-compliant. […]
Weekly reads: NuVida gets FDA warning, Dutch clinic doc ban, upbeat stem cell news Read More »
Is there hope for bipartisan support of science these days? I think so, but we’re in a big hole here in the US. Plus, some of the leaders are digging. Still, new proposed legislation provides a bit of hope. Before we get into that, Cathy Tie, whose Manhattan Project intends to make gene-edited babies right
An NIH fetal tissue research ban is now unfolding. Human embryonic stem cell research funding may be next. Such politically-motivated actions are bad for science and our country. NIH fetal tissue research ban I’ve been concerned for months that NIH might ban funding of both human fetal tissue research and possibly human embryonic stem cell (hESC)
NIH fetal tissue research ban unfolding; hESC work next? Read More »
Both Japan’s regenerative medicine framework and the system of FDA-centric oversight here in the US have allowed large numbers of unproven stem cell clinics to flourish. While the US stem cell clinic problem has gotten major attention, many in the field may not realize that there may be hundreds of unproven clinics that offer biologics
Woman dies after unproven regenerative medicine at clinic in Japan Read More »
Perinatal biologics supplier Platinum Biologics recently received an FDA warning letter. A second perinatal biologics firm, Innate Healthcare Institute, was also recently warned. I’m primarily going to focus on the warning to Platinum Biologics, but both letters have a paradoxical element to them. Why? These warnings provide some hope of normalcy in FDA biologics oversight
There are many potential emerging brain cell therapies. I’m particularly excited now about the potential of stem cells for Parkinson’s based on three recent early trial reports. Now one of those trials has given more details. Immunosuppression & brain cell therapies Control of immune response in an iPSC-based allogeneic cell therapy clinical trial for Parkinson’s
How does animal cloning work, and could human cloning become a reality soon? This came to mind again because of a recent piece in The Atlantic. Apparently, animal cloning is now so common that there are even races of horses that are clones of each other. Camel cloning is also a thing. Animal cloning expands
Deja ewe or eww: expansive animal cloning raises some difficult questions Read More »
After Hongkui Deng first reported chemical reprogramming with mouse cells more than ten years ago, I thought that this approach might overtake genetic approaches for making iPS cells. That hasn’t happened. As much as using chemical cocktails allows for iPS cell production without genetic changes, transient genetic approaches can achieve the same kind of outcome.
Weekend reads: chemical reprogramming, fat precursors, HSCs Read More »
A tech entrepreneur named Cathy Tie is talking about eventually making gene-edited babies in the U.S. via something she is calling the Manhattan Project. What should we make of this? The fact that she recently married He Jiankui who made those three CRISPR’d babies is relevant here even if they may have recently also gotten
Cathy Tie, He Jiankui’s ex-wife, starts ‘Manhattan Project’ to make CRISPR babies Read More »
A new paper from George Church on trying to make human oocytes from stem cells seems notable for quite a few reasons. Something I’ve called stem cell IVF could be a future goal for Church’s work. Over the years, Church has also discussed possible heritable human gene editing, even for traits, as potentially a positive.
Weekly reads: George Church egg paper, Chinese biotech, stem cells & pleasure, Li & AD Read More »