The company, which has struggled in the clinic following a deal where Pfizer bought its migraine portfolio, is licensing the dual inhibitor drug from a Chinese firm for up to $970m.

If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.

New long-term data from Novartis’s Zolgensma and Roche’s Erysdi will help close the gap on Biogen’s market leader Spinraza, but the three therapies look set to develop distinct or even complementary roles as the market matures.

Neuroscience and oncology fuel high hopes for therapeutic R&D progress among 90-plus surveyed biopharma industry leaders.