Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allurion, Artera, Corwave, Diamicron, Dymicron, Minogue, Personalis, SS Innovations, Tempus AI, Vektor Medical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Intuitive, Scopio, Simbiosys, Synchrony.
Actithera A/S is poised to bring small-molecule pharmacokinetics to radiopharmaceuticals after closing a $75.5 million series A that will fund initial clinical development of a candidate targeting the elusive fibroblast activation protein (FAP).
Degradation is a therapeutic strategy that could offer possibilities to get at currently undruggable target proteins. In targeted degradation, compounds induce interactions between a target protein and a protein that can tag the target for degradation. In principle, there are several pathways that could be used for such tagging; the most attention has gone to ubiquitin ligases, in particular cereblon, a protein that is part of a ubiquitin ligase complex and the target of several approved drugs.
Alcon AG plans to acquire Lumithera Inc., adding its photobiomodulation (PBM) device designed to treat early and intermediate dry age-related macular degeneration (AMD) to the Alcon portfolio. The financial terms of the deal were not disclosed.
The move continues Alcon’s strategic expansion in eye care, following on its recent acquisitions of Aurion Biotech Inc. and Lensar Inc.
The next FDA device user fee agreement is formally in negotiations but a recent agency report shows device makers are increasingly keen to interact with FDA reviewers. This is a fact that may make it difficult to keep the next user fee schedule from increasing dramatically over the current agreement.
The U.S. FDA noted in a series of Federal Register declarations that several device makers are working with the Patent and Trademark Office to claim regulatory review times for their devices, including the Sapien 3 Ultra Resilia device by Edwards Lifesciences Corp.