Search Results for: sickle cell

Regener-Eyes maker gets FDA warning on amniotic eye drops

Regener-Eyes

The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its owner, Carl R. Harrell, MD. What’s the deal with this warning? Let’s start

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He Jiankui says he’s back in the lab after prison for CRISPR babies

He Jiankui

Earlier this year Chinese researcher He Jiankui finished his prison sentence. When I saw that news I wondered about the next chapter for him. It seems he’s already back in the lab doing genetics research. At least that’s according to a blog by He Jiankui himself. Can we trust that what he has written on his website is

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Weekly reads: NurOwn, key gene screen, MS, Croce mess

Nurown BrainStorm

I get a lot of questions about stem cells for ALS and more recently people have been specifically interested in NurOwn from BrainStorm Cell Therapeutics. Recently, the FDA denied BrainStorm’s request for a BLA for NurOwn. The company felt its Phase III trial was encouraging. It sounds like they will move forward with a follow-up

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Magenta Therapeutics Good News-Bad News Trial Data

Magenta

Magenta Therapeutics is a biotech company with a portfolio including stem cell products. Their most well known investigational drug product is an expanded umbilical cord stem cell product called MGTA-456, an “ex-Novartis” product. Magenta just released new trial data on MGTA-456, which I see as a case of good news-bad news, and investors seem to

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Countering that Pro-Heritable Human CRISPR WSJ Piece

human-embryo-modification

It’s germline, heritable human CRISPR time, right? Wrong. But the particularly enthusiastic supporters of heritable human CRISPR often cite hypothetical benefits in glowing terms, but either don’t mention risks or strongly downplay them. These fans also tend to leave alternative, proven and safe technologies such as preimplantation genetic diagnosis (PGD) out of the discussion or

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