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NEWS

Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)

Shots: Otsuka Pharmaceutical has reported interim P-III (VISIONARY) trial data evaluating sibeprenlimab (400mg, SC, Q4W) vs PBO in ~510 IgAN pts, who were on SoC therapy Trial showed a 51.2% reduction in 24hr. uPCR (1EP) at 9mos. (presented at ERA 2025) & will continue to assess kidney function (2EP) via eGFR over 24mos., with completion…
June 6, 2025

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Astrazeneca
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AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

Shots: The EC has approved Calquence (acalabrutinib) + venetoclax ± Gazyva for the treatment of adults with 1L CLL; regulatory review is ongoing in other regions Approval was based on the P-III (AMPLIFY) trial assessing Calquence regimen with or without Gazyva vs chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in treatment-naïve CLL pts without del(17p) or TP53 mutation Trial showed…
June 6, 2025

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NEWS

Tracer Biotechnologies Collaborates with QIAGEN to Co-Develop and Commercialize Tracer dPCR & Tracer WGS for Solid Tumors

Shots: Tracer has entered into a strategic collaboration with QIAGEN to co-develop & commercialize Tracer dPCR & Tracer WGS MRD assays for solid tumors on QIAGEN’s QIAcuity digital PCR platform Collaboration aims to provide highly sensitive, cost-effective, & decentralized MRD testing using QIAcuity’s PCR platform, allowing oncologists to monitor cancer recurrence & guide personalized treatment…
June 6, 2025

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NEWS

Avicenna.AI Receives European CE Mark Approval for its CINA-VCF Quantix and CINA-CSpine

Shots: Avicenna.AI has received the European CE Mark approval for its AI-powered tools, CINA-VCF Quantix & CINA-CSpine to detect & assess unsuspected vertebral compression fractures (VCFs) & cervical spine fractures, respectively in pts undergoing CT scans CINA-VCF Quantix analyzes chest &/or abdomen CTs in pts (≥50yrs.), where it automatically labels vertebrae as well as calculates…
June 6, 2025

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NEWS

HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots: China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapy NDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…
June 5, 2025

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Akesobio
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Akeso’s Cadonilimab Receives the NMPA’s Approval for 1L Treatment of Cervical Cancer

Shots: The NMPA has approved cadonilimab + Pt-based CT ± Avastin as a 1L treatment of persistent, recurrent, or metastatic cervical cancer Approval was based on the P-III (COMPASSION-16) trial assessing cadonilimab vs SoCs, which met its PFS & OS endpoints, showing efficacy in PD-L1-negative tumors (CPS <1; 27.9% vs 24.2%) with subgroup analyses demonstrating benefit…
June 5, 2025

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Alvotech & Dr. Reddy’s
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Alvotech Collaborates with Dr. Reddy’s to Co-Develop a Biosimilar Version of Keytruda

Shots: Alvotech has entered into a collaboration & license agreement with Dr. Reddy’s to co-develop, manufacture & commercialize a biosimilar version of Merck's Keytruda (pembrolizumab) globally As per the deal, Alvotech & Dr. Reddy’s will jointly develop & manufacture the biosimilar candidate, sharing costs & responsibilities, with each retaining the right to commercialize it globally,…
June 5, 2025

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Cullinan and Genrix Bio
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Cullinan Therapeutics Enters a ~$712M Licensing Deal with Genrix Bio for Velinotamig

Shots: Genrix Bio has granted Cullinan exclusive global license to velinotamig, excl. Greater China for all indications, with Cullinan planning to develop it in autoimmune diseases As per the deal, Genrix will receive $20M upfront, ~$292M in development & regulatory milestones & ~$400M in sales-based milestones, with net sales-based tiered royalties from mid-single digits up to…
June 5, 2025

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