G-BA Assessment Outcomes

Germany G-BA Assessment Outcomes

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GSK to Acquire RAPT in $2.2 Billion Deal, Adding Late-Stage Anti-IgE Candidate Ozureprubart for Food Allergy and Chronic Spontaneous Urticaria | iPharmaCenter

GSK has entered into a definitive agreement to acquire RAPT Therapeutics, expanding its Respiratory, Immunology & Inflammation pipeline with a late-stage, long-acting anti-IgE antibody for food allergies. The transaction is valued at approximately 2.2 billion dollars in equity and is expected to close in the first quarter of 2026, subject to customary regulatory approvals. Through this acquisition, GSK will gain global rights to ozureprubart, a next-generation, long-acting mo

EMA Begins Review of Trastuzumab Deruxtecan Plus Pertuzumab as First-Line Therapy for HER2 Positive Metastatic Breast Cancer | iPharmaCenter

The European Medicines Agency (EMA) has accepted for review a Type II variation application for trastuzumab deruxtecan in combination with pertuzumab as an initial treatment option for adults with unresectable or metastatic HER2 positive breast cancer. The antibody drug conjugate, discovered by Daiichi Sankyo and co‑developed and co‑commercialized with AstraZeneca, is already authorized in later‑line HER2 positive settings, and this filing seeks to move the regimen into the f

Novartis’ ianalumab moves a step closer to approval in Sjögren’s disease with FDA Breakthrough Therapy designation | iPharmaCenter

Novartis has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational medicine ianalumab for the treatment of Sjögren’s disease, a systemic rheumatic autoimmune condition that ranks among the most common in its class. About ianalumab and its mechanism of action Ianalumab is a fully human monoclonal antibody engineered with a dual mechanism that both depletes B cells and blocks their activation and survival th