Sevabertinib, a potential treatment for HER2-mutant non-small cell lung cancer (NSCLC), has received priority review designation from the FDA. Christine Roth of Bayer highlighted the significance of this milestone, emphasizing the unmet need and potential of sevabertinib to improve outcomes for patients. If approved, sevabertinib could address critical unmet needs and offer hope to a […]
Tag: Bayer
FDA Priority Review for Sevabertinib NDA in HER2 Lung Cancer
Sevabertinib, an investigational oral treatment, is under Priority Review by the FDA for patients with HER2+ non-small cell lung cancer (NSCLC) and other solid tumors harboring HER2-activating mutations. Developed through a research collaboration between Bayer and the Broad Institute of MIT and Harvard, Sevabertinib is a reversible tyrosine kinase inhibitor (TKI) specifically designed to target […]
Regeneron’s Strategic Licensing for Dual GLP-1/GIP Receptor Agonist
Regeneron Pharmaceuticals, Inc. expands its clinical-stage obesity portfolio through a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited. This agreement grants Regeneron exclusive rights outside of China for HS-20094, a novel dual GLP-1/GIP receptor agonist. The In-Licensing Transaction involves potential benefits, regulatory considerations, and anticipated clinical development pathways. Regeneron aims to address obesity-related comorbidities […]
Rewriting the Code: How AI is Transforming Viral Vector Design
In the rapidly advancing world of cell and gene therapy, viral vectors have become the molecular vehicles driving transformative treatments forward. These engineered viruses—most commonly Adeno-Associated Viruses (AAVs) and Lentiviruses (LVs)—are designed to deliver therapeutic genetic material into human cells, enabling everything from gene replacement and silencing to reprogramming immune cells in the fight against […]
