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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 13, 2025 – Oct 17, 2025)    

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below: Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas Read More: Arcus Biosciences HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib…
October 17, 2025

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Roche
NEWS

Roche’s Elecsys pTau181 Test Receives the US FDA’s Clearance to Rule Out Alzheimer’s Disease

Shots:The US FDA has cleared the Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)Elecsys pTau181 was evaluated in a non-interventional study of 312 participants, showing 97.9% negative predictive value (NPV) in an early disease-stage, low-prevalence populationElecsys pTau217 is an in-vitro diagnostic…
October 14, 2025

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NEWS

NEXTBIOMEDICAL Enrolls First Patient in RESORB Trial of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis

Shots:NEXTBIOMEDICAL has enrolled the first patient in the RESORB trial, evaluating Nexsphere-F vs intra-articular corticosteroid injections for use in GAE in ~126 US pts with painful knee osteoarthritisNexsphere-F data from 155 pts published in The JVIR showed a 67% average pain reduction at 6mos., while a study published in The OJSM demonstrated safety…
October 14, 2025

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NEWS

Surgical Theater’s SyncAR Spine Platform Secures the US FDA’s 510(k) Clearance for Spine Surgery

Shots:The US FDA has granted 510(k) clearance to SyncAR Spine platform to enhance precision in spine surgerySyncAR Spine, integrated with Medtronic StealthStation, uses AI-driven vertebra segmentation, advanced decompression planning, & segmental fusion to streamline surgical planning & help align preoperative models with intraoperative CTSyncAR Spine also allows surgeons to monitor bone removal…
October 13, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 06, 2025 – Oct 10, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:     AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer Read More: AstraZeneca and Daiichi Sankyo AstraZeneca Reports P-III (Bax24) Trial Data on…
October 10, 2025

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NEWS

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Shots:Vektor Medical has received the European CE Mark approval for vMap System for non-invasive arrhythmia mappingvMap System converts 12-lead ECG data into 3D arrhythmia source maps within a minute to help identify arrhythmia drivers & guide treatment for atrial fibrillation & ventricular tachycardiaThe system also integrates with lab workflows to deliver rapid, non-invasive,…
October 8, 2025

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NEWS

IceCure Medical’s ProSense Cryoablation System Receives the US FDA Marketing Authorization for Breast Cancer

Shots:The US FDA granted De Novo marketing authorization to ProSense cryoablation system for treating women (≥70yrs.) with biologically low-risk breast tumors (≤1.5cm) on adjuvant endocrine therapyProSense is a minimally invasive cryosurgical tool that uses liquid nitrogen to freeze & destroy tumors in breast, kidney, lung & liver, with similar safety & efficacy observed…
October 6, 2025

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NEWS

Roche and KlinRisk Secure CE Mark for Kidney Klinrisk Algorithm and Unveil CKD Algorithm Panel

Shots:Roche & KlinRisk have received CE-mark approval for the AI-based Kidney Klinrisk Algorithm to assess progressive kidney function decline, integrated into the navify Algorithm SuiteThe chronic kidney disease algorithm panel combines the new Klinrisk Algorithm for early risk assessment with the CE-marked KFRE Algorithm for later disease stages, supporting care across the full…
October 6, 2025

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