Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain
the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in
Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles
and JavaScript.
From branded generics to drugs developed specifically for patients in Asia, Bethan Hughes investigates the strategies that large-cap pharmaceutical companies are pursuing to meet the medical needs of emerging markets.
The Head of the Clinical Trials Unit at the Paul Ehrlich Institute in Germany discusses the progress of a 'one stop shop' to assess applications for multinational clinical trials in Europe.
Biomarker strategies are increasingly being applied in drug development to address the challenges posed by heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses. With the aim of enhancing understanding of the regulatory significance of such biomarker data by regulators and sponsors, the US FDA initiated a programme in 2004 to allow sponsors to submit exploratory data voluntarily, without immediate regulatory impact. This article discusses a selection of case studies from the first 5 years of this programme, highlighting lessons learned.
The key roles of mitochondria in energy production and the regulation of apoptosis are frequently deregulated in cancer. Attempts to activate the cell death machinery in cancer cells by inhibiting tumour-specific alterations of the mitochondrial metabolism or by stimulating mitochondrial membrane permeabilization, could represent a promising strategy for the treatment of cancer.
Most current obesity therapies aim to reduce calorific intake or absorption and are limited by poor efficacy or unpleasant side effects. Here, Tseng and colleagues discuss the therapeutic potential of the alternative approach of increasing cellular energy expenditure, principally by stimulating adaptive thermogenesis, to prevent or treat this disorder.
The use of many current autoimmune disease therapies is hampered by their lack of specificity and adverse effects. Here, Faustman and Davis present the new approach of activating tumour necrosis factor receptor 2, to selectively destroy autoreactive immune cells and avoid toxicity.
