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.

Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs.

The U.S. Commerce Department isn't expected to complete its Section 232 investigation to build a national security case for imposing tariffs on biopharmaceuticals until the end of the month, but that didn’t stop President Donald Trump from once again teasing a “very, very high” tariff for medicines and their ingredients.

With the June 9 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee party-line vote of 12-11, Susan Monarez’s nomination is headed to the Senate floor where she could become the first CDC director to go through the confirmation process. That’s thanks to a provision in the bipartisan PREVENT Pandemics Act that was signed into law in 2022.

Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.

Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.

The U.S. Centers for Medicare & Medicaid Services indicated it will act on a previous proposal to terminate the Treatment Choices Model for ESRD at the end of the current calendar year because of a failure of the program to deliver on the promised efficiencies and improvement in outcomes.

Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.