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New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products.
Joshua Gordon, Director of the National Institute of Mental Health, discusses the evolving RDoC framework for research into mental illnesses, and the appropriate balance between the funding of basic and clinical research.
The market for colorectal cancer therapies, which is currently dominated by drugs targeting vascular endothelial growth factor and epidermal growth factor receptor, is poised for change with the anticipated entry of immunotherapies and other targeted drugs.
There has been a resurgence in interest in phenotypic drug discovery (PDD) approaches in recent years based on their potential to address the incompletely understood complexity of diseases and their promise of delivering first-in-class drugs. However, PDD approaches can also present considerable challenges, and this article focuses on the lessons learned by researchers engaged in PDD in the pharmaceutical industry, and discusses how PDD can best deliver value to drug discovery portfolios.
Existing pain therapies are often inadequate or associated with side effects. Here, Woolf and colleagues discuss new and existing strategies for the development of improved pain therapeutics, highlighting key challenges and considerations in the clinical development of novel analgesics.
Flaviviruses, including dengue and Zika viruses, are of substantial public health concern. Klein and colleagues review the development of broad-spectrum antiviral agents that would target many of the known and potentially unknown flaviviruses. The benefits and caveats of molecules that target either viral proteins or host mechanisms exploited by these viruses are discussed.
