Bio-Techne Corp. plans to sell its Exosome Diagnostics Inc. business to Mdxhealth SA for $15 million plus royalty payments, a steep cut from the $250 million the company paid to acquire Exodx in 2018. Mdxhealth estimates the unit will generate $20 million in revenue in 2026. Read More
The U.S. Department of Health and Human Services has tapped Sean Keveney for the job of FDA chief counsel, but the recent history of the position muddies the waters when it comes to HHS oversight of FDA legal affairs. Read More
The U.S. FDA has staked out a position on the use of per- and polyfluoroalkyl substances in medical devices, declaring that the evidence offers no reason to restrict their continued use in med-tech products. Read More
Precision medicine is becoming a reality in Asia Pacific as more targeted therapies are being developed that are tailored to individual patients, offering a potential cure for disease. But is Asia Pacific ready to harness this transformation, and if not, what are the hurdles that need to be cleared? A new report by LEK Consulting examines Asia Pacific’s readiness for what it calls the “Precision Era,” and examines four key biopharma markets in Australia, China, Japan and South Korea. Read More
New hires and promotions in the med-tech industry, including: Channel Medsystems, Continuity Biosciences, Flatiron Health, Mallinckrodt, Milestone Scientific, Morphic Medical, Tensive. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Respiree. Read More
