Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bionano, Bridge to Life, Caredx, Implantica, Paragonix.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Daxor, Deephealth, Instylla, Pearl Diagnostics, Thermo Fisher Scientific.
With half-year industry financings down 59% from last year, and a U.S. administration supportive of cryptocurrencies, biopharma companies are building treasuries of digital assets to secure future R&D efforts and operational runways. Companies such as Artelo Biosciences Inc., MEI Pharma Inc., Windtree Therapeutics Inc. and 180 Life Sciences Corp. and have entered crypto deals in recent weeks, with the latter noting the potential to “unlock value outside traditional biotech milestones.”
Subtyping is what made precision medicine in cancer a reality. And for successful drug discovery in all its stages, finding subtypes in Alzheimer’s disease is all but imperative.
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.
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.
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.