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Regulatory actions for Aug. 11, 2022

Aug. 11, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aro, Bavarian, Bridgebio, Lexaria, Sentynl, Trethera.
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Briefcase with Eye-Sync device, tablet

Syncthink secures CE mark for neurologic diagnostic system

Aug. 10, 2022
By Nuala Moran
Syncthink Inc. is preparing to launch its neurological impairment and disease diagnostic in Europe, after securing CE marking for the ocular biomarker device. The company is raising a new round of funding to support commercialization of the Eye-Sync system and has two projects exemplifying applications of the device running with academic collaborators in the U.K.
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Regulatory actions for Aug. 10, 2022

Aug. 10, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medicalgorithmics, Shanghai Jienuo.
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Regulatory actions for Aug. 10, 2022

Aug. 10, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cormedix, Ferring, Immunis, Novaliq, Reata, Rebiotix, Relmada.
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Man undergoing MRI scan for prostate cancer diagnosis

FDA advances AI-enhanced tech for prostate diagnosis and treatment

Aug. 9, 2022
By Annette Boyle
Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.
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Person standing on Bodyport scale in bathroom

Bodyport claims FDA clearance for cardiac weight scale

Aug. 9, 2022
By Catherine Longworth
The U.S. FDA granted digital therapeutics company Bodyport Inc. 510(k) clearance for its heart monitoring weight scale. The digital solution includes sensors and algorithms that measure hemodynamic biomarkers to assess heart function and fluid status when patients take their daily weight. San Francisco-based Bodyport told BioWorld the platform is for heart failure (HF) patients in the U.S.
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Nothing misleading here, US First Circuit tells Karyopharm investors

Aug. 9, 2022
By Mari Serebrov
An investor’s wish to know more about the total landscape of a drug candidate is not enough, on its own, to make a company’s disclosures about the drug and its development materially misleading. So said the U.S. Court of Appeals for the First Circuit in affirming the dismissal of a shareholder suit against Karyopharm Therapeutics Inc. and its executive officers.
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FDA approves Daiichi Sankyo/Astrazeneca’s Enhertu for HER2 low metastatic breast cancer

Aug. 9, 2022
By Tamra Sami
The U.S. FDA has approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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Regulatory actions for Aug. 9, 2022

Aug. 9, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda, Bodyport, Bot Image, Cerevasc, Imspex Diagnostics, Medalliance, Neuroone.
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Regulatory actions for Aug. 9, 2022

Aug. 9, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bayer, Daiichi, Immvira, Myovant, Orion, Scisparc, Tracon.
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