Nature Reviews Drug Discovery 7, 871 (2008). doi:10.1038/nrd2745

A wealth of genomic data for pathogens that cause diseases such as malaria is now available, but translating this knowledge into much-needed new drugs represents a major challenge. In their Perspective, authors from a global network of public and private partners discuss the development of

Nature Reviews Drug Discovery 7, 873 (2008). doi:10.1038/nrd2746

How might the challenges of demonstrating the value of new drugs be approached in the context of growing pressures on health-care budgets?

Nature Reviews Drug Discovery 7, 875 (2008). doi:10.1038/nrd2748

Author: Dan Jones

New studies have affirmed the complexity of genetic changes in solid tumours, but also revealed commonalities in the associated pathways, suggesting that a pathway-oriented perspective could aid cancer drug discovery and therapy.

Nature Reviews Drug Discovery 7, 876 (2008). doi:10.1038/nrd2749

Author: Bethan Hughes

A recent report from the European Commission highlights the increasing importance of payer considerations in demonstrating product value through clinical development programmes.

Nature Reviews Drug Discovery 7, 878 (2008). doi:10.1038/nrd2750

Budget and resource boosts for global health challengesPhilanthropists and industry continue to commit funds and research resources to tackle diseases including malaria, HIV/AIDS and tuberculosis.The lowdown: As part of a US$3 billion pledge for a Global Malaria Action Plan to reduce the

Nature Reviews Drug Discovery 7, 880 (2008). doi:10.1038/nrd2752

In a deal that could potentially be worth up to US$820 million, GlaxoSmithKline (GSK) has gained the exclusive, worldwide development and commercialization rights to retigabine, a first-in-class potassium-channel opener developed by Valeant Pharmaceuticals for the treatment of epilepsy. GSK will also gain the rights to

Nature Reviews Drug Discovery 7, 880 (2008). doi:10.1038/nrd2753

A Phase III trial of Johnson and Johnson's investigational drug ustekinumab in patients with moderate to severe psoriasis has shown that it is more effective — and requires far fewer injections — than etanercept (Enbrel; Amgen/Wyeth).In the 12-week study, reported at the 17th meeting

Nature Reviews Drug Discovery 7, 881 (2008). doi:10.1038/nrd2754

Ablynx and Merck Serono have entered into an agreement to co-discover and co-develop nanobodies — a class of antibody-derived therapeutic proteins — against two unspecified targets in oncology and immunology. Under the agreement, Ablynx receives an upfront cash payment of 10 million euros, and the

Nature Reviews Drug Discovery 7, 882 (2008). doi:10.1038/nrd2751

Author: Charlotte Harrison

Injunction keeps Mircera off the US marketAn injunction granted by a US district court, which addresses issues of patent infringement and public interest, prevents the US marketing of Roche's anti-anaemia drug Mircera (methoxy polyethylene glycol-epoetin beta).Amgen owns six US patents that relate to

Nature Reviews Drug Discovery 7, 884 (2008). doi:10.1038/nrd2732

The President of the Critical Path Institute discusses the successes to date and future challenges of helping the FDA to improve the process for developing safe, innovative drugs.

Nature Reviews Drug Discovery 7, 885 (2008). doi:10.1038/nrd2733

Authors: Janice M. Reichert, Stephanie L. Rochon & Bodi D. Zhang

The US Food and Drug Administration's (FDA's) Fast Track programme has existed for a decade. Created as Section 112 of the FDA Modernization Act of 1997, the programme is designed to facilitate the development and expedite the review of drugs and biologics that are intended

Nature Reviews Drug Discovery 7, 887 (2008). doi:10.1038/nrd2741

Authors: Douglas B. Cines, Uma Yasothan & Peter Kirkpatrick

In August 2008, romiplostim (Nplate; Amgen), a thrombopoietin receptor agonist, was approved by the US FDA for the treatment of thrombocytopaenia in patients with chronic immune thrombocytopaenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

Nature Reviews Drug Discovery 7, 889 (2008). doi:10.1038/nrd2738

Author: Monica Hoyos Flight

Amyloid-β (Aβ) peptides are thought to have a key role in the neurotoxicity and cognitive decline that occur in Alzheimer's disease (AD), but there have recently been several disappointments with late-stage clinical trials of agents that target Aβ. Two recent papers in Nature Medicine

Nature Reviews Drug Discovery 7, 890 (2008). doi:10.1038/nrd2737

Author: Charlotte Harrison

Acute lung injury can develop during the course of clinical conditions such as pneumonia, acid aspiration, major trauma and prolonged mechanical ventilation, and although many episodes resolve spontaneously, it can lead to critical illness. Little is known about how to prevent the interstitial and intra-alveolar

Nature Reviews Drug Discovery 7, 890 (2008). doi:10.1038/nrd2739

Author: Alexandra Flemming

Atherosclerosis is the most common cause for heart attacks, stroke and cardiovascular death. The main risk factor for clinical complications is atherosclerotic plaques, which can develop into complex, unstable forms that are prone to rupture. Reporting in Nature Medicine, Wilensky and colleagues now demonstrate

Nature Reviews Drug Discovery 7, 891 (2008). doi:10.1038/nrd2735

Author: Sarah Crunkhorn

The need for new drugs to combat multidrug-resistant bacteria remains pressing. Now, two recent papers published in Science describe novel agents that target different mechanisms to currently approved antibacterials, which may help tackle this challenge.The first study, by Haydon and colleagues, set out

Nature Reviews Drug Discovery 7, 892 (2008). doi:10.1038/nrd2736

Author: Man Tsuey Tse

Since the discovery of a cardioprotective mechanism known as preconditioning — induced by repetitive sub-lethal ischaemic events — there has been a search for agents that could mimic this effect and thereby limit damage caused by cardiac ischaemia. Writing in Science, Mochly-Rosen and colleagues

Nature Reviews Drug Discovery 7, 892 (2008). doi:10.1038/nrd2740

Viral diseasesDiscovery of a hepatitis C target and its pharmacological inhibitors by microfluidic affinity analysis.Einav, S.et al. Nature Biotech.26, 1019–1027 (2008)More effective therapies are urgently needed against hepatitis C virus (HCV). This

Nature Reviews Drug Discovery 7, 893 (2008). doi:10.1038/nrd2728

Authors: Christian K. Schneider & Gabriele Schäffner-Dallmann

Although regulatory standards and procedures in Europe have improved following the establishment of the European Medicines Agency (EMEA), the number of major issues with marketing authorization applications for biotechnological products remains high. For example, the pivotal clinical trials of some late-stage failures have been found

Nature Reviews Drug Discovery 7, 900 (2008). doi:10.1038/nrd2684

Authors: Fernán Agüero, Bissan Al-Lazikani, Martin Aslett, Matthew Berriman, Frederick S. Buckner, Robert K. Campbell, Santiago Carmona, Ian M. Carruthers, A. W. Edith Chan, Feng Chen, Gregory J. Crowther, Maria A. Doyle, Christiane Hertz-Fowler, Andrew L. Hopkins, Gregg McAllister, Solomon Nwaka, John P. Overington, Arnab Pain, Gaia V. Paolini, Ursula Pieper, Stuart A. Ralph, Aaron Riechers, David S. Roos, Andrej Sali, Dhanasekaran Shanmugam, Takashi Suzuki, Wesley C. Van Voorhis & Christophe L. M. J. Verlinde

The increasing availability of genomic data for pathogens that cause tropical diseases has created new opportunities for drug discovery and development. However, if the potential of such data is to be fully exploited, the data must be effectively integrated and be easy to interrogate. Here,

Nature Reviews Drug Discovery 7, 909 (2008). doi:10.1038/nrd2358

Authors: Rocio S. Lopez-Diego & Howard L. Weiner

Therapeutic strategies for multiple sclerosis have radically changed in the past 15 years. Five regulatory-approved immunomodulatory agents are reasonably effective in the treatment of relapsing–remitting multiple sclerosis, and appear to delay the time to progression to disabling stages. Inhibiting disease progression remains the central challenge

Nature Reviews Drug Discovery 7, 926 (2008). doi:10.1038/nrd2682

Authors: Ioannis Prassas & Eleftherios P. Diamandis

Cardiac glycosides are a diverse family of naturally derived compounds that bind to and inhibit Na+/K+-ATPase. Members of this family have been in clinical use for many years for the treatment of heart failure and atrial arrhythmia, and the mechanism of

Nature Reviews Drug Discovery 7, 936 (2008). doi:10.1038/nrd2685

Authors: Norberto Perico, Ariela Benigni & Giuseppe Remuzzi

At present, there are no specific cures for most of the acquired chronic kidney diseases, and renal transplantation is limited by organ shortage, therefore present efforts are concentrated on the prevention of progression of renal diseases. There is robust experimental and clinical evidence that progression

Nature Reviews Drug Discovery 7, 955 (2008). doi:10.1038/nrd2747

In recent years, public, private and philanthropic organizations worldwide have started to work together to discover and develop new medicines to treat neglected diseases. This month, we feature two people involved in these public–private partnerships.