PharmaShots Weekly Snapshots (Sep 01, 2025 – Sep 05, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, Animal Health and Biosimilars. Check out our full report below:   Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF) Read More: Merck AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat…

ByRidhi Rastogi11 hours ago

NEWS

Roche Reports the European CE Mark Approval of Contivue to Treat Neovascular Age-Related Macular Degeneration

Shots: Roche has received the European CE Mark approval for Contivue, a port delivery platform containing Susvimo (Lucentis) for the treatment of neovascular age-related macular degeneration (nAMD); Susvimo (100mg/mL) is under the EMA’s review Approval was backed by P-III (Archway) trial & additional studies, a P-II (LADDER) trial, & Portal OLE long-term study, with Archway showing…

ByRidhi Rastogi18 hours ago

NEWS

AliveDx Reports the US FDA’s 510(k) Submission for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

Shots: The US FDA has received 510(k) premarket notification for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease; available in IVDR CE-marking countries since Jul 2025 VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM…

ByRidhi Rastogi2 days ago

NEWS

GE HealthCare Launches Vivid Pioneer for Enhanced Cardiac Imaging

Shots: GE HealthCare has launched Vivid Pioneer, a cardiovascular ultrasound for 2D, 4D, & color flow imaging, following the European CE Mark approval & the US FDA’s 510(k) clearance Vivid Pioneer is powered by cSound architecture & XDclear tech to provide superior resolution, color sensitivity, & 4D imaging, allowing structure visualization & cardiac function assessment…

ByRidhi Rastogi4 days ago

VIEWPOINTS

AI-Mediated Recalls: Shawn Opatka from Honeywell in a Riveting Dialogue Exchange with PharmaShots

Shots: Product recalls in biopharma and MedTech incur an unanticipated drain on budget, costing the industry between $2.5B to $5B per year on average Honeywell’s TrackWise Recall Management helps biopharma and MedTech companies plan and execute recall processes seamlessly, contributing to improved patient safety and faster response times Shawn Opatka, Vice President & General Manager,…

BySaurabh Chaubey4 days ago

NEWS

Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

Shots: Abbott has received the CE Mark approval for Navitor transcatheter aortic valve implantation(TAVI) system to expand its use in people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery Approval was backed by VANTAGE study of Navitor TAVI, which met its safety & efficacy 1EPs in above pts Trial showed…

ByRidhi Rastogi5 days ago

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 25, 2025 – Aug 29, 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:  argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis Read More: argenx PDS Biotech Reports Final P-II (VERSATILE-002) Survival Data for PDS0101 + Keytruda…

ByRidhi RastogiAugust 29, 2025

NEWS

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

Shots: BioPorto has reported the US launch of the ProNephro acute kidney injury (AKI) test through its collaboration with Roche, following its FDA 510(k) clearance on Roche’s cobas c 501 analyzers for hospital clinical laboratories ProNephro AKI (NGAL) is an AKI biomarker test for pediatric use (3mos.–21yrs.), which helps identifying ICU pts at risk of…

ByRidhi RastogiAugust 28, 2025

NEWS

Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

Shots: Airiver Medical has received the US FDA’s IDE approval to initiate trial for Airiver Pulmonary Drug Coated Balloon (DCB) for the treatment of central airway stenosis The study will assess safety & efficacy of Airiver Pulmonary DCB against SoC bare balloon dilation in ~200 pts with central airway stenosis & support the US FDA…

ByRidhi RastogiAugust 28, 2025

NEWS

Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

Shots: Abbott has received European CE Mark approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with peripheral artery disease (PAD) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty in pts (n >260) with PAD BTK, which showed sustained efficacy & ability to open vessels…

ByRidhi RastogiAugust 27, 2025

PharmaShots Weekly Snapshots (Sep 01, 2025 – Sep 05, 2025)

AliveDx Reports the US FDA’s 510(k) Submission for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

GE HealthCare Launches Vivid Pioneer for Enhanced Cardiac Imaging

AI-Mediated Recalls: Shawn Opatka from Honeywell in a Riveting Dialogue Exchange with PharmaShots

Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

PharmaShots Weekly Snapshots (Aug 25, 2025 – Aug 29, 2025)

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

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