As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

After a brief lull in US initial public offerings, PainReform and three special purpose acquisition companies kicked off September’s IPOs. Also, Immunovant offering grossed $173.9m, Carlyle Group bought 5% stake in China’s Salubris and Erasca increased its series B to $236m. 

Intercept and Axcella provide updated data on their NASH programs at the International Liver Conference, while CymaBay offers the full dataset for seladelpar in PBC.

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.