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As concerns over the adverse effects of the diabetes drug rosiglitazone (Avandia; GlaxoSmithKline) keep the spotlight focused on safety issues in the ongoing debate on drug regulation and the role of regulators such as the FDA and EMEA, it is important that the value of continuing to improve the regulatory processes leading to drug approval is not forgotten.
Few truly innovative drugs for central nervous system (CNS) disorders have been approved in recent years, suggesting that there is a need for strategies to improve the productivity of research and development in this field. The authors describe approaches that are being taken to discover CNS drugs, discuss their relative merits and consider how risk can be balanced and attrition reduced.
There is much debate worldwide over how governmental policies affect pharmaceutical innovation. Ensuring the safety of drugs must be offset against providing timely access to potentially life-saving or life-enhancing therapies. The authors argue that there is a need for a more balanced approach to governmental interventions.
Members of the RAS superfamily of monomeric GTPases are promising anticancer targets, but previous attempts to therapeutically modulate their activity, which have focused on the development of farnesyltransferase inhibitors, have not proved as successful as hoped. The authors discuss novel approaches targeting prenylation and post-prenylation modifications and the functional regulation of GDP/GTP exchange as exciting alternatives for anticancer therapy.
With the development of genome-wide RNAi approaches, the cost and time involved in target identification, validation and other aspects of drug discovery could be significantly reduced. Ashworth and colleagues review technologies available for RNAi screens and discuss how cancer drug discovery can benefit from their application.
Protein-fragment complementation assays (PCAs) can be used to explore the dynamics of protein–protein interactions, and regulatory responses to intrinsic or extrinsic perturbations of biochemical pathways. Michnick and colleagues discuss the rationale behind the PCA design, and its manifold applications for drug discovery.