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Toll-like receptor agonists have hit another setback with the Phase II failure of Idera's IMO-2055, but these immunotherapies may still make a comeback if appropriate combinations with vaccine antigens or anticancer drugs can be identified.
This analysis of the outcomes of advisory committee meetings held by the US Food and Drug Administration (FDA) over the past decade investigates issues such as the consistency between advisory committee votes and FDA approval decisions.
Here, Lawson proposes that the use of antibodies as tools in small-molecule drug discovery — for example, to validate targets, enable crystallography and to constrain proteins for screening — could reduce risks and facilitate the modulation of traditionally intractable targets, such as protein–protein interactions.
Biopharmaceuticals are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions (also known as biosimilars). Jones and colleagues discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation.
During the past decade, there have been substantial advances in our understanding of the pathogenesis and genetics of eye diseases. Focusing on glaucoma and retinal disorders, Zhang and colleagues review the current status of ocular drug therapy, discuss novel agents currently in development and clinical trials and highlight recent advances in drug delivery.
The paucity of treatments for schizophrenia might be partly due to the lack of suitable animal models in which to assess potential new drugs. Here, the authors highlight how new rodent models that are based on a better understanding of the genetics and neural circuitry underlying schizophrenia could lead to the development of more effective drugs.
