The Belgian firm has the go-ahead from the US FDA for an advanced depression program for ANT-01 including the endpoint of improvement in cognitive function, which could differentiate its label.

There have been lots of twists and turns on the development path for Inrebic which is now the second JAK inhibitor to be approved in the EU for MF since the blockbuster Jakavi was cleared in 2012.

Trek Therapeutics expands its HCV pipeline by in-licensing polymerase inhibitor from Medivir. ProMetic gains cash, tax offsets and physical plant by acquiring fellow Canadian firm Telesta for pennies per share, while Cell Medica inks its second academic cancer immunotherapy collaboration of 2016, this time with University College London.

A repeat of FDA’s record-breaking NME approval performance from recent years looks unlikely, even though the 14 novel approvals in the first half of 2016 equals the first half total for 2015, because almost one-third fewer novel candidates have user fee goals in the second half.