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The growth of precision medicine presents challenges for the regulators of medicines, related to aspects that include the basis of evidence generation, patient involvement in the regulatory process, cost of new medicines and the need for new regulatory models. It also raises questions about the tolerance of risk, especially with early interventions for life-threatening diseases.
Pivotal trials of Alkermes's antidepressant ALKS 5461 show how a patented clinical trial design might be able to help control problematic placebo responses.
Drug developers are still hunting for surrogate end points that can better capture the benefits of checkpoint inhibitors, oncolytic viruses and modified T cell therapies.
Carole Ho, Chief Medical Officer at Denali Therapeutics, discusses how genetic findings have paved the way for one of the largest start-ups to take on neurodegeneration.
This article analyses recent data on the reported causes of drug candidate attrition, which indicate that lack of efficacy is the reason for approximately half of all phase II and phase III failures.
Infection with HIV-1 is currently incurable as HIV-1 can persist as integrated provirus in the genome of latently infected CD4+T cells, where it is invisible to the immune system and not responsive to drugs. Here, Ferrari and colleagues discuss the development of novel engineered bispecific and trispecific antibodies, particularly dual-affinity re-targeting (DART) proteins, designed to eradicate latently infected cells.
The modification of epigenetic markers has become an attractive approach to cancer treatment. Here, Prinjha and colleagues discuss the use of epigenetic modulators in inflammatory diseases, which could be particularly amenable to this approach, as immune memory is often encoded in epigenetic changes. Although the field is still at an early stage, many compounds have been found to be more specific than previously thought and could soon enter clinical trials for autoimmune and inflammatory conditions.
The calpain family of proteases are involved in numerous physiological and pathological processes. Here, Sorimachi and colleagues provide an overview of the calpain superfamily and calpain-related disorders, assess the various emerging approaches for therapeutically targeting calpains and highlight agents currently in clinical trials.
