Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocartis, Bivacor, Fujifilm, Mira Precision Health, Novartis, Oxford Cancer Biomarkers, Viz.ai.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clarity, Hyperfine.
Despite the advancement of AI and machine learning technologies and their incorporation into cancer treatment and drug development, a lack of trust and understanding of these new approaches is impeding care and treatment.
At the 61st American Society of Clinical Oncology (ASCO) Annual Meeting, multiple companies presented clinical trial data showing their drugs and devices helped patients with pancreatic cancer live longer or improve their ability to respond to treatment.
Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance on primary and key secondary endpoints and offering hopes of a regulatory pathway ahead.
Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its Sapien M3 system and is a boon for mitral valve therapies amid ongoing frustrations about the slow adoption of TMVR technologies.
The U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.”
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