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Abbvie

AbbVie’s Maviret Receives EC Approval for Acute Hepatitis C Virus Infection

Shots: The EC has approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in pts (≥3yrs.) with compensated liver disease (with or without cirrhosis) Approval was based on the P-III (M20-350) trial assessing Maviret (QD, PO) in pts (≥12yrs.) with acute HCV infection, enrolling 286 treatment-naïve adults across 70 locations globally Trial…

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Combotope Therapeutics and Boehringer Ingelheim Collaborate on Next-Generation Cancer Antibody Therapies

Shots: BI has entered into a strategic research collaboration with Combotope to leverage its SMART-Phage platform to produce highly tumor-selective antibodies for next-generation cancer therapies Combotope will discover tumor-selective, high-affinity antibodies against multiple BI oncology targets, while BI will hold global development & commercialization rights, and lead further R&D, manufacturing, & commercialization activities As per…

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Spotlight Medical Gains CE Mark for myStage Dx as an AI-Based Prognostic Test for ER+/HER2- Early Breast Cancer

Shots: Spotlight Medical has received CE marking under the EU IVDR for myStage Dx, an AI-enabled prognostic test designed to support risk stratification in patients with ER+/HER2- early breast cancer Test analyzes digitized H&E-stained FFPE pathology slides alongside routine clinicopathological variables to generate a binary prognostic classification of Low Risk or Not Low Risk In…

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Abbisko Therapeutics Inks ~$1.9B Multi-Target R&D Deal with Eli Lilly

Shots: Abbisko Therapeutics has entered into a strategic research collaboration & license agreement with Eli Lilly to discover & develop novel therapeutics across multiple targets Abbisko will leverage its early-stage drug discovery platform, R&D ecosystem, & development expertise to conduct discovery & early-stage development of novel therapeutics against disease targets selected by Lilly As per…

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Henlius & Organon

Organon and Henlius Launch Bildyos and Tuzemty (Biosimilars, Prolia and Xgeva) in Canada

Shots: Organon & Henlius Biotech have reported availability of Bildyos (60mg/1mL) & Tuzemty (120mg/1.7mL), biosimilar versions of Prolia & Xgeva (denosumab), respectively, in Canada for all indications of reference products Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights, excl. China, for multiple biosimilars, incl. Bildyos & Tuzemty Denosumab is a mAb that works…

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Nuvectis Expands Pipeline with ~ $1.46B Ex-China Licensing Deal for Two Late-Stage Assets from Haisco

Shots: Nuvectis has licensed exclusive ex-China rights to NXP100 (HSK39297; QD, PO), a Complement Factor B inhibitor, & NXP200 (HSK42360), a brain-penetrant paradox-breaker BRAF inhibitor from Haisco, transforming the company into a late-stage development player  As per the deal, Haisco will receive ~$40M in upfront & near-term payments, plus up to $1.421B in development,…

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