The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.
Junshi’s Checkpoint Inhibitor Ready to Head to Regulators for Throat Cancer
Biologics License Application (BLA), Checkpoint Inhibitors, China, China National Medical Products Administration (NMPA), Clinical Trials, Conditional Approval, FDA/Regulatory, Interim Analysis, Nasopharyngeal Carcinoma (NPC), Progression-Free Survival (PFS), R&D, Throat CancerJunshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.
Johnson & Johnson Dives Into 2018 With 15 New Deals
Adeno-Associated Virus (AAV), Alzheimer's Disease, Artificial Intelligence, Collaborations, COPD, Deals, Diabetes, Diagnostics, Digital Health, Elderly, G-Protein-Coupled Receptors, Gene Therapy, Lung Cancer, Microbiome, Myopia, Neurodegenerative Diseases, Neuroscience, Oncology, Ophthalmology, Skin Conditions, Throat CancerJohnson & Johnson Innovation kick started 2018 by striking collaborative agreements with 15 different organizations and companies to address areas of high unmet medical need in neuroscience, oncology and other areas.