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August 2017 Volume 16 Number 8 | Advertisement | ||||||||||||||||||||||||||||||||||||
In this issue Comment News and Analysis Research Highlights Perspectives Reviews
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Comment: Combination products: modernizing the regulatory paradigm Nina L. Hunter & Rachel E. Sherman p513 | doi:10.1038/nrd.2017.66 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. Abstract | Full Text | PDF | |||||||||||||||||||||||||||||||||||||
NEWS AND ANALYSIS | Top | ||||||||||||||||||||||||||||||||||||
Calls grow to tap the gold mine of human genetic knockouts Asher Mullard p515 | doi:10.1038/nrd.2017.139 A Human Knockout Project would systematically search for loss-of-function genetic mutations in humans to help uncover new drug targets. | |||||||||||||||||||||||||||||||||||||
NEWS IN BRIEF FDA approvals for the first 6 months of 2017 Asher Mullard p519 | doi:10.1038/nrd.2017.148 | |||||||||||||||||||||||||||||||||||||
FDA approves first new sickle cell drug in 20 years Asher Mullard p519 | doi:10.1038/nrd.2017.149 | |||||||||||||||||||||||||||||||||||||
New cancer vaccines show clinical promise Asher Mullard p519 | doi:10.1038/nrd.2017.150 | |||||||||||||||||||||||||||||||||||||
BIOBUSINESS BRIEFS Market watch: Strategies for biosimilars in emerging markets Ajay Gautam p520 | doi:10.1038/nrd.2017.113 | |||||||||||||||||||||||||||||||||||||
BIOBUSINESS BRIEFS Patent watch: Supreme Court decision favours biosimilars Courtenay C. Brinckerhoff p521 | doi:10.1038/nrd.2017.136 | |||||||||||||||||||||||||||||||||||||
AN AUDIENCE WITH Joshua Gordon p523 | doi:10.1038/nrd.2017.134 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. | |||||||||||||||||||||||||||||||||||||
FROM THE ANALYST'S COUCH Colorectal cancer drugs market Sorcha Cassidy & Basharut A. Syed p525 | doi:10.1038/nrd.2017.59 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. | |||||||||||||||||||||||||||||||||||||
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PERSPECTIVES | Top | ||||||||||||||||||||||||||||||||||||
OPINION Opportunities and challenges in phenotypic drug discovery: an industry perspective John G. Moffat, Fabien Vincent, Jonathan A. Lee, Jörg Eder & Marco Prunotto p531 | doi:10.1038/nrd.2017.111 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. Abstract | Full Text | PDF | |||||||||||||||||||||||||||||||||||||
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REVIEWS | Top | ||||||||||||||||||||||||||||||||||||
Breaking barriers to novel analgesic drug development Ajay S. Yekkirala, David P. Roberson, Bruce P. Bean & Clifford J. Woolf p545 | doi:10.1038/nrd.2017.87 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. Abstract | Full Text | PDF | |||||||||||||||||||||||||||||||||||||
Broad-spectrum agents for flaviviral infections: dengue, Zika and beyond Veaceslav Boldescu, Mira A. M. Behnam, Nikos Vasilakis & Christian D. Klein p565 | doi:10.1038/nrd.2017.33 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. Abstract | Full Text | PDF | Supplementary information | |||||||||||||||||||||||||||||||||||||
Corrigendum: Upcoming market catalysts in Q3 2017 Sonny Nghiem p586 | doi:10.1038/nrd.2017.138 Full Text | PDF | |||||||||||||||||||||||||||||||||||||
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