Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that oh-so familiar routine of online meetings and deadlines has predictably returned. After all, the world — such as it is — somehow continues to spin. To cope, we are brewing cups of stimulation. Our choice today is glazed doughnut. One can never be too sweet, yes? Meanwhile, here is the latest grab bag of interesting items for you to peruse. We hope your day is productive and meaningful. And please do stay in touch. We appreciate the insights and tips. …
The U.S. Food and Drug Administration disclosed some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing methods used to evaluate a risk of inadvertently making unwanted changes to patient DNA, STAT explains. None of the concerns suggest the agency is reluctant to approve the treatment, which was developed by Vertex Pharmaceuticals and CRISPR Therapeutics. FDA staff said the type of gene editing raises concerns about “off-target” unintended genomic alterations. The small genetic sample size used in a lab analysis may not be sufficient for safety assessment because it did not capture the diversity of the entire U.S. population for the disease.
The FDA warned consumers to not purchase or use certain eye drops from several brands because they may cause eye infection and in some cases possible vision loss, Reuters writes. The agency recommended against the use of 26 over-the-counter eye drop products mainly used to treat symptoms of dry eyes and provide relief against eye irritation. The eye drops are marketed by CVS Health, Rite Aid, and Cardinal Health, among others. The FDA also asked the manufacturer to recall all lots of the product after its investigators found insanitary conditions in the manufacturing facility.