Vicore Pharma Holding AB was granted a U.S. FDA breakthrough device designation for Almee, a cognitive behavioral therapy (CBT) software, to be used as an adjunct treatment by patients with anxiety symptoms due to pulmonary fibrosis. Vicore developed the nine-week CBT digital therapy in partnership with Alex Therapeutics AB.
Laboratory Corporation of America Holdings expanded its blood biomarker test portfolio for Alzheimer’s disease, making its pTau217 test available by prescription in the U.S. as well as for research globally. The standalone test can also be used in monitoring patients undergoing treatment for the neurodegenerative disease.
The U.S. FDA has followed up on reports of problematic syringes made by several companies in mainland China, recommending that U.S. suppliers, consumers and health care organizations stop using these products unless no alternatives are available. The agency said it has issued warning letters to three of these companies, at least one of which appears to have been the supplier of Monoject syringes that have been the subjects of recent FDA recalls.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bayer, Infutronix, Livanova, Proverum, Thermo Fisher.
Scientists at the Weizmann Institute of Science in Israel announced the discovery of the new intestinal microbiota species Kazachstania weizmannii in mice, which competed with and limited the growth of Candida albicans, thus preventing candidiasis. Both microorganisms belong to the Saccharomycetaceae family and reside in humans, maintaining a complex interaction with therapeutic value.
Validating Fusion Pharmaceuticals Inc.’s radiopharmaceutical technology and manufacturing capabilities, Astrazeneca plc offered to buy the firm for $2 billion up front in cash, plus a contingent value right that could raise the total deal value by another $400 million.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inheart, Peca Labs.