DBV Technologies SA’s pivotal phase III trial with the Viaskin Peanut allergy patch came through for the company, and officials plan a BLA filing with the U.S. FDA in the first half of next year. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Dec. 17 at $22.55, up $4.57, or 25%, on positive top-line results from the study called Vitesse with Viaskin for children, ages 4 to 7.
The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of changes that would present a significant reset of both regulations. One of the more sweeping changes would be to exempt medical technologies from much of the text of the Artificial Intelligence Act, a move that would ease the drag on AI-based technologies in the EU.
Siemens Healthineers AG became the latest company to sign a licensing agreement with Alzpath Inc. to use its pTau217 antibody in the development of a blood-based diagnostic assay for Alzheimer's disease. Alzpath previously signed deals with the likes of Roche AG and Beckman Coulter Diagnostics Inc. to use its pTau217 antibody to create diagnostic tests based for early detection and monitoring of Alzheimer's.
