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Despite high safety hurdles and a history of failure in the field, some drug firms remain cautiously optimistic for the next wave of experimental anti-obesity agents.
As the US FDA prepares to implement an abbreviated pathway for follow-on biologics, it gathered stakeholders to discuss key concerns. Analytical assessment and clinical development programmes were high on the agenda.
For more than 50 years, warfarin has been the standard of care for long-term anticoagulation therapy in the United States, but now the FDA has approved the first oral anticoagulant that could replace it.
Do the lack of efficacy and the increase in the risk of skin cancer seen in Phase III trials of Eli Lilly's γ-secretase inhibitor undermine the potential of targeting this enzyme for the treatment of Alzheimer's disease?
The controversy over the diabetes drug rosiglitazone (Avandia; GlaxoSmithKline), a peroxisome proliferator-activated receptor-γ agonist, has undermined confidence in developing drugs that target this family of nuclear receptors, but some companies still see promise in the field.
Highlighted by Genentech's recent US regulatory submission for trastuzumab–DM1, antibody–drug conjugation technology could be heading for the mainstream in anticancer drug development.
New recommendations to change the diagnostic criteria for Alzheimer's disease and recent advances in biomarker development may allow earlier diagnosis of this disease, potentially providing key tools for drug development.