Innovent Reports the US FDA’s IND Clearance of IBI3032 for Cardiometabolic Disorders

Shots: The US FDA has approved IND application of IBI3032 to initiate P-I trial for cardiometabolic disorders The P-I trials will be initiated simultaneously in China & the US, with dosing in healthy & overweight or obese participants anticipated to start in H2’25 IBI3032, an oral GLP-1 receptor agonist biased toward the cAMP pathway, showed…

ByRidhi RastogiAugust 5, 2025

NEWS

AliveDx Receives the CE Mark Approval for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

Shots: AliveDx has received the European IVDR-CE mark approval for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM VAS assay allows accurate serological evaluation with…

ByRidhi RastogiAugust 5, 2025

NEWS

BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has accepted sBLA & granted priority review to Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy (PDUFA: Dec 5, 2025) sBLA is supported by the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl.…

ByRidhi RastogiAugust 5, 2025

NEWS

The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Shots: The US FDA has granted FTD to RNS60 (oxygen-enriched saline) for the treatment of acute ischemic stroke Designation was based on extensive preclinical data & P-II (RESCUE) trial, which showed reduced brain tissue loss, improved functional outcomes, & shorter hospital stays in pts treated within 24 hours of stroke onset Additionally, Revalesio is planning…

ByRidhi RastogiAugust 4, 2025

NEWS

Turbine Collaborates with Merck to Use AI-Driven Tumor Simulation for Identifying Novel Targets in Hard-to-Treat Cancers

Shots: Turbine has entered into a research collaboration with Merck to simulate hard-to-treat cancer pts populations that are challenging to study in traditional lab settings As per the deal, Meck will leverage Turbine's Simulated Cells to develop virtual tumor models that mimic hard-to-study, treatment-resistant subtypes to validate novel targets, biomarkers, & combination therapies Collaboration includes…

ByRidhi RastogiAugust 4, 2025

NEWS

Materna Medical Reports Enrolment Completion in EASE Trial of Ellora System to Reduce Pelvic Injury from Vaginal Delivery

Shots: Materna Medical has completed enrolment in its EASE trial of Ellora Obstetrical System (formerly Materna Prep device) for first-time mothers Trial will evaluate safety & effectiveness of the Ellora System vs SoC in 420 first-time mothers for the reduction of pelvic muscle injury during vaginal delivery; EASE trial will support the upcoming US FDA’s…

ByRidhi RastogiAugust 4, 2025

NEWS

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

Shots: The US FDA has approved IND application of ABT-301 to initiate P-I/II trial for pts with metastatic colorectal cancer (mCRC) Trial will assess ABT-301 + Tevimbra (provided by Beone) + Avastin in ~66 pts across Taiwan & Australia, with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC Additionally, Anbogen is pursuing global licensing,…

ByRidhi RastogiAugust 4, 2025

NEWS

Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD)

Shots: Roche has reported data from the ongoing OLE P-III (Portal) study of Susvimo (port delivery platform with Lucentis) for the treatment of nAMD The P-III (Archway) trial assessed Susvimo (Q6W refill, n=248) vs Lucentis (QM, IVT, n=168) in 415 nAMD pts responsive to prior anti-VEGF therapy; 352 entered the Portal OLE study, where 132…

ByRidhi RastogiAugust 4, 2025

NEWS

Sanofi Enters a ~$395M Asset Purchase Agreement with Visirna Therapeutics (Arrowhead) for Plozasiran in Greater China

Shots: Visirna Therapeutics, a subsidiary of Arrowhead, has granted Sanofi exclusive rights to develop & commercialize plozasiran for treating familial chylomicronemia syndrome (FCS) & severe hypertriglyceridemia (SHTG) in Greater China As per the deal, Visirna will receive $130M upfront & ~$265M in milestone payments across indications, along with net sales-based royalties in Greater China, as…

ByRidhi RastogiAugust 4, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 28, 2025 – Aug 01, 2025) 

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Animal Health and Biosimilars. Check out our full report below: Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients Read More: Memo therapeutics Eli Lilly Reports Topline P-III (BRUIN…

ByRidhi RastogiAugust 1, 2025

Ridhi Rastogi

Innovent Reports the US FDA’s IND Clearance of IBI3032 for Cardiometabolic Disorders

AliveDx Receives the CE Mark Approval for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Turbine Collaborates with Merck to Use AI-Driven Tumor Simulation for Identifying Novel Targets in Hard-to-Treat Cancers

Materna Medical Reports Enrolment Completion in EASE Trial of Ellora System to Reduce Pelvic Injury from Vaginal Delivery

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

Sanofi Enters a ~$395M Asset Purchase Agreement with Visirna Therapeutics (Arrowhead) for Plozasiran in Greater China

PharmaShots Weekly Snapshots (Jul 28, 2025 – Aug 01, 2025)

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