QUICK HITS

1First CRISPR Drug Could Launch Next Year A recent Fast Company article discussed a new development in the world of gene editing. Though the tech won Jennifer Doudna and Emmanuelle Charpentier the 2020 Nobel Prize in Chemistry, we still haven’t seen a practical application we can wrap our heads around. Until now. Vertex, a company focused on rare diseases, teamed up with CRISPR Therapeutics to develop a therapy to treat rare genetic blood disorders like beta thalassemia and sickle cell disease. The drug is called exa-cel, and it cost nearly a billion dollars to develop. It reportedly eliminates the need for blood transfusions and their complications. Exa-cel is expected to seek regulatory approval in the U.S., UK, and

Europe by the end of 2022, so it could receive marketing authorization in 2023.

2Patient Receives 3D Printed Ear

Transplant

A recent Reporter Wings article discussed a new procedure in which doctors corrected a microtia defect by transplanting a 3D printed ear made of human cells. The procedure was conducted by a pediatric ear reconstructive surgeon in San Antonio, and the trial was funded by 3DBio Therapeutics. Executives at the company noted that with further research, the technology could be used to replace other body parts including spinal discs, noses, knee menisci, rotator cuffs, and reconstructive tissue for lumpectomies. Eventually it could lead to 3D printed complex vital organs such as livers or kidneys.

3Impossibly Small Robot to Perform Tasks

in the Body

A recent Medgadget article covered an innovative new medical robot that resembles a crab and measures just half a millimeter wide. Capable of jumping, twisting, bending, turning, and walking, the remote-controlled crab robots were developed by engineers at Northwestern University. They do not require electricity and are made of a shape-memory alloy. For video of the tiny crab robots in action, visit hcpgo.to/404

4Nephron Pharma Recalls 2+ Mil Products A recent WIS News article discussed that 2.1 million doses of medicine and medical equipment (including syringes and bags) from Nephron Sterile Compounding Center were recalled due to “lack of assurance of sterility.” “Out of an abundance of caution, Nephron is proactively cooperating with the Food and Drug Administration on a voluntary recall of a limited number of product lots. We do not take this lightly,” said a statement from the CEO and Owner. “While there has been no impact to patient safety, and there is no evidence of contamination, Nephron has decided in the interest of patients to proceed with this recall process.” 5California is

Making its Own Affordable Insulin

A recent article from The Verge covered California’s plan to combat the skyrocketing prices of life-saving insulin by making its own. Some people are paying $300 to $500 a month to treat their diabetes, and it’s estimated roughly 25% of people are forced to ration their doses. The initiative is part of Governor Gavin Newsom’s CalRx plan from 2020, aimed at lowering medication costs by partnering with manufacturers or creating their own. Newsom hasn’t announced when the insulin will be available or how much it will cost, but he’s hinted that monthly costs could be—at a minimum—cut in half.

6FDA Describes

Baby Formula Plant Conditions

By now you’re probably well aware of the nationwide baby formula shortage crisis, linked to the Feb. shutdown of Abbott Nutrition’s plant in Sturgis, MI. A New York Times article outlined FDA commissioner Dr. Robert Califf’s description of plant conditions to lawmakers. He described “egregiously unsanitary” conditions including a leaking roof, water pooled on the floor, and cracked production equipment that created breeding grounds for bacteria. Califf took responsibility for how slowly the agency responded to the plant’s problems, but noted that the agency worked with Justice Department officials to outline corrective steps for Abbott. The plant reopened on June 4, closed for flooding briefly, and reopened July 9.

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