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9th Circuit hearing on FDA appeal of Cell Surgical Network case: maybe encouraging?

Cell Surgical Nework

I was able to watch some of the 9th Circuit Court hearing today on the FDA appeal of its loss in the Cell Surgical Network lawsuit. This post is my brief impressions as a scientist. What went down? Do the three judges seem to be leaning one way or another? The ruling in this case …

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Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

AXIOFILL, MiMedx

Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter …

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Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics

AABB, FDA

The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges, …

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Weekly reads: FDA OKs 2 gene therapies for sickle cell, new Paolo Macchiarini series, Fujifilm

Marie Tornyenu, Casgevy gene therapies for sickle cell

The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for …

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FDA warns Neil Riordan U.S. perinatal firm Signature Biologics

Signature Biologics, Neil Riordan

Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama  clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the …

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Weekly reads: stem cells for MS, Kimera Labs IND, FDA lawsuit

Symptoms_of_multiple_sclerosis

There has been a steady stream of encouraging data on stem cells for MS. Particularly for certain kinds of MS. A new study adds to this upbeat direction. Good news on stem cells for MS Haematopoietic stem cell transplantation for treatment of relapsing-remitting multiple sclerosis in Sweden: an observational cohort study, Journal of Neurology, Neurosurgery, …

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BrainStorm Cell Therapeutics Hail Mary with FDA on Nurown for ALS

MSF-NTF cells, NurOwn

BrainStorm Cell Therapeutics is developing Nurown, an investigational therapy intended for treating ALS. I recently posted about BrainStorm and its prospects for providing real hope on stem cells for ALS. I see it as a long shot. The ALS community needs real hope, but one challenge is determining how good clinical data have to be to …

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Weekly reads: big Retraction Watch news, stem cells & metastasis, an FDA approval, Iowa AG sues clinic

Retraction watch

Retraction Watch has been a great resource for those of us who have been following research misconduct. They widely cover and conduct research on retractions, corrections, and other developments in this space. Unfortunately, there’s been plenty to write about even just within the stem cell and cell therapy arena, which is my primary interest. Think …

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Goldwater Institute weighs in against FDA on Cell Surgical Network lawsuit appeal

Elliot Lander, Cell Surgical Network

An important appeals case is pending not just for the defendants Cell Surgical Network, et al., but also for the FDA. It could impact the stem cell field very broadly too. Cell Surgical Network lawsuit status Hopefully, we’ll get a decision before the end of this year. Cell Surgical Network is a large chain of …

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FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity

Dr. Leonid Macheret, FDA warning

Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this …

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