In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further, …
Clinic biz US Stem (USRM) may be kaput in matter of weeks or months Read More »
It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several …
Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions Read More »
Here are my recommended weekly reads for The Niche readership for early February 2021 including COVID-19 and stem cell lawsuit updates, papers, and more. How many papers do you end up reading each week or month these days? More or less than before the pandemic? COVID-19 updates New diabetes cases linked to covid-19, WaPo ICYMI …
The Niche reads: COVID, new INDs, clinic suits, papers Read More »
Last year around this time I took my annual plunge to make 20 predictions for the coming year for the stem cell and regenerative medicine field. I even made a crystal ball graphic to highlight the complexity of the stem cell ecosystem into which these predictions were embedded (see image) for 2019. How’d I do? …
B+ on my report card on my 20 stem cell predictions for 2019 Read More »
US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to …
Kristin Comella resigns from embattled clinic firm US Stem Cell Read More »
The unproven stem cell clinic firm US Stem Cell Inc. is in a world of hurt. If a federal judge says you can no longer sell your key commercial offering, how do you survive as a company? US Stem probably has been thinking about that possibility for months. Still, it’s not yet clear where the …
Can clinic biz US Stem reboot after losing suit? Its email to customers & more Read More »
It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently). …
Reactions to historic stem cell clinic court loss, new court order, & what happens next? Read More »
As I broke the news yesterday, the high-profile fat stem cell clinic firm U.S. Stem Cell (USRM) just lost a groundbreaking court case. Here is the FDA’s official reaction today to the court ruling. Also, since the ruling major media have been covering the court ruling. Here are some examples: From the Washington Post from …
Fallout of big court loss for stem cell clinic whose leader tweeted conspiracy claim Read More »
In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is …
Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court Read More »
When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman. …