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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 29, 2025 – Oct 03, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:   Daiichi Sankyo & AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer Read More: Daiichi Sankyo & AstraZeneca Merck Presents P-III (HYPERION) Trial Data…
October 3, 2025

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NEWS

Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

Shots:Hologic has received the US FDA’s 510(k) clearance & European IVDR CE Mark approval for its Panther Fusion Gastrointestinal (GI) Bacterial & Expanded Bacterial AssaysPanther Fusion GI assays quickly detect key bacterial pathogens causing infectious gastroenteritis, incl. Salmonella, E. coli (incl.O157), Campylobacter, Shigella, Vibrio, Yersinia, & Plesiomonas, using customizable molecular mini-panels to allow…
October 3, 2025

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Abbott
NEWS

Abbott Receives Health Canada’s Approval for Esprit BTK System to Treat Chronic Limb Threatening Ischemia Below the Knee

Shots:Abbott has received Health Canada’s approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with chronic limb-threatening ischemia (CLTI) below the knee (BTK)Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty, which showed improved patient outcomes, with 48% fewer repeat procedures over the study period. Data was highlighted…
October 1, 2025

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Novocure
NEWS

Novocure Reports Final P-III (METIS) Trial Data on Tumor Treating Fields (TTFields) Therapy for Brain Metastases from NSCLC

Shots:The P-III (METIS) trial assessed TTFields therapy + best supportive care (BSC) (n=149) vs BSC (n=149) in 298 adults with 1-10 newly diagnosed brain metastases from NSCLC following stereotactic radiosurgery; median TTFields use was 67% over 16wks.Trial met its 1EP, with a 28% lower risk of intracranial progression, extending median time to 15…
September 30, 2025

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NEWS

HemoSonics Secures the US FDA’s 510(k) Clearance for Quantra Hemostasis System in Obstetric Procedures

Shots:The US FDA has granted 510(k) clearance to Quantra Hemostasis System with QStat Cartridge, expanding its use in peripartum obstetric procedures to help manage postpartum hemorrhageQuantra is a cartridge-based viscoelastic testing system that uses SEER Sonorheometry tech to provide fast, point-of-care whole-blood coagulation analysis in <15min., enabling individualized & evidence-based decisions, along with…
September 26, 2025

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NEWS

Medtronic’s Altaviva Device Receives the US FDA’s Approval to Treat Urge Urinary Incontinence

Shots:The US FDA has approved the Altaviva device, an implantable tibial neuromodulation therapy to treat urge urinary incontinenceAltaviva device is placed under the skin above the fascia & near the ankle in a minimally invasive, sedation & imaging-free procedure to restore bladder–brain communication & improve bladder control by delivering electrical impulses to the tibial…
September 22, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:   MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC Read More: MAIA Biotechnology Akeso Reports First…
September 19, 2025

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Amber implants
NEWS

Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures

Shots:The US FDA has granted 510(k) clearance to VCFix Spinal System for thetreatment of vertebral compression fracturesThe company plans to launch a US pilot program in early 2026, expand physician access later that year, extend the EXPAND trial into the US, & pursue EU label expansion for stand-alone use & one-level fixation integration…
September 17, 2025

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