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Astrazeneca
News
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 regionsApproval 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 mutationTrial showed…
June 6, 20250Comments
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 platformCollaboration 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, 20250Comments
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 scansCINA-VCF Quantix analyzes chest &/or abdomen CTs in pts (≥50yrs.), where it automatically labels vertebrae as well as calculates…
June 6, 20250Comments
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 therapyNDA 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, 20250Comments
Akesobio
News
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 cancerApproval 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, 20250Comments
Alvotech & Dr. Reddy’s
News
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) globallyAs 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, 20250Comments