While the weaker yen boosted the top line for Japanese pharma companies with a strong global presence in the fiscal first half, it also raised reported costs. Several firms reported strong growth for mainstays, while holding out high hopes for selected new drugs with blockbuster potential. But some other products underperformed for unexpected reasons.

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

Novo Nordisk’s metabolic juggernaut semaglutide is known to work in chronic kidney disease – but the group appears to want a back-up plan. 

In a major boost for Santhera and Duchenne muscular dystrophy patients, EU regulators have backed the firm’s Agamree for children aged four years and older and a launch in Germany is scheduled for January.