Zydus Cadila expects domestic sales to improve and the US generics business to grow in “mid to high” single digits during FY21 after both saw a coronavirus-related hit in Q1. Meanwhile, approvals for a few biologics are expected, its COVID-19 vaccine candidate has just entered Phase II studies and the firm has just launched its Remdac version of remdesivir.

Zydus Cadila expects domestic sales to improve and the US generics business to grow in “mid to high” single digits during FY21 after both saw a coronavirus-related hit in Q1. Meanwhile, approvals for a few biologics are expected, its COVID-19 vaccine candidate has just entered Phase II studies and remdesivir launch looms.

The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.

Weeks after lifting of an FDA clinical hold, CymaBay says it will resume development of its PPAR agonist in primary biliary cholangitis. It will initiate a new Phase III trial but also use data from a terminated Phase III study.