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Y-Mabs
NEWS

SERB Pharmaceuticals to Acquire Y-mAbs Therapeutics for ~$412M

Shots: SERB Pharmaceuticals has entered into a definitive merger agreement to acquire Y-mAbs, incl. its asset Danyelza (naxitamab-gqgk), strengthening its rare oncology portfolio As per the deal, SERB will acquire Y-mAbs for a total equity value of ~$412M, with its shareholders receiving $8.6/share in cash, delisting Y-mAbs from Nasdaq; closing expected in Q4’25 Additionally, Y-mAbs’ pipeline incl.…
August 6, 2025

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NEWS

Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

Shots: Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar version of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s disease As per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will…
August 5, 2025

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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…
August 5, 2025

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BMS
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.…
August 5, 2025

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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…
August 4, 2025

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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…
August 4, 2025

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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…
August 4, 2025

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