CNS 'Graveyard Of Drug Development' Needs Oncology-Like FDA Regulatory Approach
Executive Summary
Lundbeck executive calls for adaptive trial designs, transdiagnostic approach, and more scientific discussions between sponsors and the US Food and Drug Administration.
You may also be interested in...
Genomics Data Should Get More Attention In FDA Drug Review And Labeling, Regeneron Says
Regeneron advocates industry-FDA collaboration to establish regulatory standards for novel applications of genomic data, such as determining whether long-term outcomes studies are needed, and inclusion of the data in product labeling.
Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent
Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.
Drug Review Reorganization At US FDA Coming Into Focus
Oncology, neuroscience, and infectious diseases get acting directors as the expansion and renovation of the Office of New Drugs moves into Phase II.