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Portola's andexanet alfa and Boehringer Ingelheim's idarucizumab are both due to be filed for approval this year, with big potential implications for novel oral anticoagulants.
The IL-17–TH17 pathway is a popular target for the treatment of psoriasis and other autoimmune conditions. Bartlett and Million discuss the key agents in the pipeline, several of which are expected to gain approval in the near future.
Butlen-Ducuing and colleagues analyse ~20 years of data on regulatory applications assesssed by the European Medicines Agency in psychiatry and neurology, with the aim of illuminating challenges that underlie the 'pipeline problem' for drugs for central nervous system disorders.
Since its launch in 2008, the Innovative Medicines Initiative has catalysed the formation of many consortia to address challenges in drug development and regulation. As it moves into its second phase, we highlight key outcomes so far and lessons learned.