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BioWorld - Tuesday, May 5, 2026
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Regulatory actions for July 10, 2025

July 10, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Intuitive, Scopio, Simbiosys, Synchrony.
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Actithera raises $75M series A for FAP-targeted radiopharmaceuticals

July 10, 2025
By Nuala Moran
No Comments
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).
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3D rendering of a molecular glue mediating the interaction between two proteins
Drug design, drug

With surface mimicry, molecular glues shed hairpin need

July 10, 2025
By Anette Breindl
No Comments
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.
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Close up of eye and vision test

Alcon sees the light with Lumithera buy for dry AMD

July 9, 2025
By Shani Alexander
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.
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regulatory-washington-capital.png

FDA’s MDUFA report suggests pre-sub interactions increasing

July 9, 2025
By Mark McCarty
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.
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Edwards seeks to add three months to Ultra Resilia patent

July 9, 2025
By Mark McCarty
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.
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IMEC ingestible GI sensor
Patents

IMEC seeks ingestible GI sensor patent

July 9, 2025
By Simon Kerton
Researchers from IMEC, the Netherlands’ OnePlanet Research Center in Wageningen, filed for protection of an inexpensive, highly miniaturized ingestible device that may be used for remotely activatable sampling, gut health monitoring and drug delivery.
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Appointments and advancements for July 9, 2025

July 9, 2025
New hires and promotions in the med-tech industry, including: Mercy Bioanalytics, Merit Medical, QT Imaging, Tellihealth, Vialase.
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Financings for July 9, 2025

July 9, 2025
Med-tech firms raising money in public or private financings, including: Actithera, Neuros, Plexāā.
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In the clinic for July 9, 2025

July 9, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ultromics.
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