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Latest From Eisai Co., Ltd.

Synchron Announces Positive Results From Stentrode BCI Study, Plans For Pivotal Study

After announcing positive results showing that its Stentrode BCI is safe in six patients, brain-computer interface company Synchron is planning a pivotal trial to eventually file for FDA approval.

Clinical Trials Neurology

ESMO 24: SunRISes On J&J’s TAR-200 In Bladder Cancer

J&J acquired Taris in 2019 to gain access to TAR-200 and its drug delivery platform. Now, early clinical data suggest the product could delay or remove the need for cystectomy in several bladder cancer settings and the US healthcare giant is eyeing multi-blockbuster sales.

ESMO Clinical Trials

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

News We're Watching Approvals

Taisho Makes Japan Vornorexant Filing, Hopes To Dent Insomnia Market

Taisho’s in-house insomnia therapeutic candidate vornorexant offers a potential advantage of a shorter half-life compared to its competitors, which can contribute to patients’ QOL.

Japan Drug Review
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