Stem cell studies continue to make big news with a mixed bag of trends including for stem cell biotech, and some good stem cell news and others not so much. Mesoblast ($MESO) had its stock suspended for quite so time recently in anticipation of a big announcement. When that news came today it was discouraging in […]
Stem cell biotech bites: Mesoblast, BioTime, MS, FDA Warning, & More Read More »
The FDA has taken another action against a manufacturer of stem cell cosmetics in the form of anti-aging creams with a warning letter sent on April 20, 2016 to Crescent Health Center, Inc. The FDA noted a number of issues in the warning letter that it termed “serious violations”, but the biggest issue was that the agency
FDA warning to stem cell cosmetics maker Read More »
Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment
FDA warning points to tougher regulation of fat stem cells & clinics Read More »
The following is a response to my Open Letter to the UK Parliament on mitochondrial transfer/3-parent technology from Drs. Peter Braude and Robin Lovell-Badge. Dear Professor Knoepfler, We read your open letter to the UK Parliament and the Science and Technology Committee with interest and concern. We are two scientists, like you, with particular interests
Osiris, a cellular therapy biotech, recently received a so-called “untitled letter” from the FDA. The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery. What’s going on here? With Halloween coming, one has
Osiris FDA Letter: Trick or Treat? Read More »
A FOIA request that I made with the FDA in mid-December 2012 has at long last revealed letters from Celltex to the FDA that previously were not in the public domain. The reason for the FOIA and for these blog posts is to shed some light on important issues that particularly relate to patient safety. I
The U.S. Supreme Court could soon have a historic opportunity to limit the scope of FDA stem cell oversight. A large stem cell clinic firm now says it plans to ask SCOTUS to review a case it recently lost on appeal to the FDA. If SCOTUS takes the case, the FDA could find its powers
FDA stem cell oversight at risk as clinics to ask SCOTUS to weigh in Read More »
Did you predict the major events in the stem cell and regenerative medicine field this year? I tried and today’s post are the grades on my predictions. Prediction is a key part of being a scientist even if we may not think about it that much. For instance, we have to try to predict what
Grading my 20 stem cell & regenerative medicine predictions for 2024 Read More »
Toward the end of each year I make predictions for the stem cell and regenerative medicine field for the coming year. I’ve been doing this for more than a dozen years in various forms. In this post I’m looking at the (gene-edited, stemness enriched) tea leaves for 2025 for the regenerative arena. These predictions include
25 stem cell & regenerative medicine predictions for 2025 Read More »
The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024. With
FDA warns Frontier Biologics as part of its more active trend Read More »