Quest Diagnostics Inc. and Pathai Inc. established a forward-looking deal with multiple components and room for growth. The collaboration includes Quest’s acquisition of Pathai Diagnostics – the division that provides anatomic and digital pathology laboratory services – and licensing of Pathai’s Aisight digital pathology image management system. The companies also said they may work together on development of Pathai’s algorithm products and that Quest will be a preferred provider for Pathai’s biopharmaceutical clinical laboratory services. Read More
Lindis Blood Care GmbH recently revealed excellent data from the Remove study that showed that its Catuvab device was safe and effective in removing tumor cells from intraoperative blood during high blood loss cancer surgeries. Read More
The U.S. Federal Trade Commission (FTC) finalized its overhaul of the health breach notification rule (HBNR), significantly expanding the types of software products subject to the agency’s oversight. However, the final rule was approved by the commission by a narrow 3-2 vote and was the subject of a scathing critique by the two dissenting commissioners, who argued that the FTC has once again exceeded its statutory authority in rewriting the HBNR. Read More
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them. Read More
By now, the story of last year’s dismal U.S. capital markets is hardly news. But when combined with increasing regulatory stresses, especially for biopharma and med-tech startups, there are elements of that story giving some Street-watchers pause, even as the market begins to show a few signs of recovery. Read More
Researchers have identified enzymes in gut microorganisms that could cleave A and B antigens from red blood, transmuting them to O negative cells. This is “a decisive step forward” in the quest to develop a universal donor blood that can be administered to people of any blood group without eliciting a harmful immune response, according to Maher Abou Hachem of the Technical University of Denmark, who co-led the research. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Andor Health, Bruker, Deep 6 AI, Detect-Ion, Elitechgroup, Efertility, Intuity Medical, Magnolia Market Access, Nuvo, Valencia Technologies, Vitrolife. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Briohealth Solutions, Owlet, United Imaging. Read More