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Despite the pressing need for new antibiotics in order to avoid a public-health crisis, antibacterial R&Dhas dwindled seriously in recent years, in part owing to a lack of incentives for companies to make investments in this field. So, the recent passing of an amendment to US legislation that will provide new incentives for antibacterial R&D is to be welcomed.
The scientific and regulatory issues associated with the possible introduction of 'follow-on' versions of protein drug products are currently attracting much attention. Past examples are discussed of the FDA's actions involving the evaluation of various types of follow-on and second-generation protein products and within-product manufacturing changes with a view to illustrating the FDA's scientific reasoning in this area.
RNA interference (RNAi) has rapidly advanced since its initial discovery to form the basis of a new class of therapeutics. De Fougerolles and colleagues discuss the challenges in the development of RNAi-based therapeutics, focusing on lead identification/optimization and effective delivery, and review the latest clinical results.
The cellular microenvironment plays a critical role in cellular responses to therapy. A greater understanding of the extracellular matrix (ECM) and ECM–cell interactions could facilitate the design of novel drug delivery systems for biomacromolecular therapies, and interventions to manipulate the microenvironment may further improve the efficiency of such therapies.
Aggregation of hyperphosphorylated tau is involved in neurodegeneration in Alzheimer's disease and other disorders. The authors discuss the progress in the design of selective kinase inhibitors that suppress tau hyperphosphorylation as a therapeutic strategy for neurodegenerative tauopathies.
Although clinical trials using matrix metalloproteinase inhibitors (MMPIs) for cancer therapy were disappointing, Opdenakker and colleagues discuss how the use of selective MMPIs might lead to new treatments for acute and chronic inflammatory and vascular diseases.
