FDA Warns Exosome Maker for Marketing Outside Its IND
The FDA has warned Kimera Labs that it can’t sell its exosome product for uses outside of its recently secured investigational new drug (IND) application. In a warning letter that was posted to the FDA’s website last September, then removed, and then posted again this month, the agency also told the Miramar, Florida-based company that […]
Infant formula safety checks can be improved with stratified sampling
Producers of infant formula employ comprehensive food safety systems, including product testing to ensure those systems are working. A new study from the University of Illinois Urbana-Champaign finds that some testing methods are more powerful at catching contaminants than others. Spacing out samples over time in a stratified sampling pattern is better at catching risky […]
OTC Narcan Approval Opens New Doors in Fight Against Opioid Crisis
This week’s FDA approval of the first-ever over-the-counter (OTC) naloxone product (Narcan) for the treatment of opioid overdoses was broadly praised, but medical and industry experts expressed caution about expanding access and its potential to address the overdose crisis. “We have nearly 200 Americans dying every day as a result of opioid-involved overdose,” said Smita […]
FDA Advisors Back Fecal Microbiome Treatment for Recurrent C. Diff
An FDA advisory board recommended the agency approve a fecal microbiota transfer (FMT) product for recurrent Clostridium difficile infections. By a vote of 13-4 on Thursday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), said RBX2660 was effective for treating patients with recurrent C. diff infections who failed first-line antimicrobial therapy. Safety landed in […]
Fungi-based meat alternatives to help save Earth’s forests
The market-ready meat alternative is very similar in taste and texture, but is a biotech product which — by replacing beef — involves much less land resources and greenhouse gas emissions from agriculture and land-use change. This goes under the assumption of a growing world population’s increasing appetite for beefy bites, and it is the […]