Innovative trial designs and biostatistics can make pediatric drug development more efficient, but strategies like extrapolating adult data using bridging biomarkers or Bayesian analyses have complex data requirements that demand coordination and forethought.

Initial doses of Novavax’s vaccine are expected to arrive in Europe in January.

BeiGene exec reveals Chinese firm's changing development strategy around key asset as further clinical results emerge.

Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.