This week we look at manufacturing investments taking place in life sciences, the Food and Drug Administration’s first Safer Technologies Program approval as well as the agency’s first full approval of a COVID-19 rapid antigen test. Finally, we highlight a story on the thriving canine population of Chernobyl.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Novo Nordisk increasing manufacturing investment in North Carolina
A recent purchase of 104 acres adjacent to its multi-billion-dollar plants manufacturing diabetes and obesity medicines could mean that Novo Nordisk is doubling down on its manufacturing investment in North Carolina. A spokesperson for the company stated, “For Novo Nordisk’s production facilities in Johnston County, these land purchases are to ensure North Carolina remains a prime location for future potential expansion plans to improve and increase production capacity.”
Middle market CDMO invests in Tennessee
A middle market contract development and manufacturing organization based out of Florida, Formulated Solutions, has acquired the former Merck & Co. and Bayer manufacturing facility in Cleveland, Tenn. The company plans to invest $44 million into the facility and create 524 new jobs. The company’s CEO stated, “With a long history of local pharmaceutical production and an abundance of well-trained, reliable workforce talent, we are excited to join the thriving local community and contribute to the area’s manufacturing legacy.”
The FDA clears the first device under the Safer Technologies Program
The FDA has cleared the first medical device under its Safer Technologies Program, or STeP, a program designed to accelerate approvals for devices that are expected to be more effective at treating or diagnosing non-life-threatening diseases or conditions than existing treatments or diagnostics. The device, the Endolumik Fluorescence Guided Gastric Calibration Tube, is intended for use during gastric and bariatric surgical procedures.
FDA issues first full clearance for rapid antigen test
The FDA has issued emergency use authorizations to 444 COVID-19 diagnostic tests and sample collection devices. The number of tests that have made it through traditional review is much smaller. The latest approval, QuidelOrtho’s rapid antigen test, is the first rapid antigen test to receive regular FDA clearance.
The unexpected thriving dog population of Chernobyl
Following the Chernobyl meltdown 37 years ago, researchers expected that a place unfit for human life would also prove unfit for other animal life. Unexpectedly, a dog population has been thriving. Researchers are now in the process of sequencing the genomes of dogs in the population to attempt to answer many questions, including how genomes cope with extreme radiation.