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NEWS

Samsung Bioepis ans NIPRO
Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan 
Shots: Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in Japan As per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activities Ustekinumab is…
June 9, 2025
Arvinas and Pfizer
Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer
Shots: FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy NDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed improved PFS (1EP) by 43%…
June 9, 2025
Formycon Receives the ANVISA Approval for Ranivisio (Biosimilar, Lucentis) Across Brazil
Shots: Brazil’s ANVISA has approved marketing authorization for Formycon’s Ranivisio (ranibizumab), a biosimilar to Lucentis; launch is anticipated in Q4’25 Formycon & Biomm have partnered to commercialize Ranivisio in Latin America, with approvals already granted in Peru, El Salvador, Honduras, and the Dominican Republic. Additional launches across Central and South America are planned through early…
June 6, 2025
Astrazeneca
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
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
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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