Every now and I then I try to take some time to think about the focus of this blog and the direction it is going. In the most recent case, I got the feeling that perhaps I have giving too discouraged or negative an impression on the blog lately….focusing too much on the challenges and […]
Why I am very optimistic about the future of the stem cell field Read More »
This is the fourth post in a series I’m doing on an FOIA release of letters between Texas stem cell clinic Celltex and the FDA. The first three posts, which include helpful background and discussion of other FOIA material from Celltex, can be found here, here, and here. Today’s post is focused on a newly
Celltex FDA FOIA Letter #3 Raises Key New Questions 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
It was my pleasure recently to talk at length with Dr. Michael West, CEO of the Stem Cell Biotech, BioTime (BTX). West has been at the helm of BioTime since 2007 and is a true pioneer in the stem cell field. He founded Geron (GERN) and was a top leader at Advanced Cell Technology (ACT; stock
Interview with BioTime CEO Michael West Part 1: a little stem cell history Read More »
Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece entitled “Our Bodies, Our Cells” a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions. Their piece really has two parts. In the first part they go through
My response to ‘Our Bodies, Our Cells’ Harvard post on deregulation Read More »
It’s difficult to make it as a biotech company, I would say stem cell biotechs in general may have an even rougher time, and one such company, Intellicell (Intellicell Biosciences, Inc), is showing a number of signs of distress in my opinion. An online financial tool predicts the probability of companies going bankrupt within the next
Stem cell company Intellicell facing new financial wrinkles Read More »
One of the more exciting stem cell biotechs out there today is Advanced Cell Technology (ACT). At this time ACT has the only two ES cell-based FDA-approved clinical trials ongoing and so far they have looked quite promising in terms of preliminary safety data. However, ACT has much more in the pipeline including potentially iPS
Interview with Gary Rabin of Advanced Cell Technology (ACT) Read More »
It has been a tough year for Korean stem cell biotech RNL Bio in my opinion. It is involved in litigation with former patients and its former partner, Celltex. It is also reportedly under investigation by the Korean Government for alleged stem cell smuggling. The stock of this publicly-traded company has also been battered. On
Tough times at stem cell company RNL Bio Read More »
An interesting paper just came out in PNAS reporting the apparent presence of a pluripotent stem cell population in the adult breast. The paper is Roy, et al. and is from Thea Tlsty’s outstanding lab at UCSF. I have read the paper and it seems very solid technically to me. The finding has stimulated some
Caution on mammary pluripotent stem cell paper Read More »
What does it take to be a stem cell biotech CEO? I really appreciate how insightful the students are with whom I interact each year including undergrads, grads, and medical students. One asked me the other day “What are the backgrounds of the CEOs of stem cell companies?” I know some of the CEOs and
What is the ideal background for a stem cell company CEO? Take our poll Read More »