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The European Medicines Agency (EMA) is inviting expressions of interest in a workshop organised together with the European Commission on March 20 to discuss potential improvements to the implementation of the European Union’s regulatory framework specific for paediatric medicines, the Paediatric Regulation. The workshop is a crucial step for the development of an action plan to address challenges to medicine development for children in Europe.

The US Food and Drug Administration is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. “We are clarifying the recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. We are adding a new Boxed Warning to highlight this information in the prescribing information of the drug label,” the agency said.

The current spread of multidrug-resistant malaria in Southeast Asia is likely to be the result of two mutations combining in 2008, according to a retrospective genetic study published in The Lancet Infectious Diseases journal. The study shows how the multidrug-resistant parasite gained increased biological fitness, spreading rapidly through the region unnoticed for 5 years until 2013.

Combating multidrug-resistant malaria

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