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.

Hikma and Dr Reddy’s Laboratories are weighing launches of their generics to Amarin’s Vascepa after the US Court of Appeals for the Federal Circuit upheld a favorable lower court ruling. The originator said it would take its appeal to the next level and continued to raise doubts over supply capacity.

A Federal Circuit panel affirmed a district court decision in favor of two generics makers, but Amarin will seek a hearing from the full 12-member appellate court. Vascepa marketing is unchanged for now.

Carbogen Amcis, LGM Pharma, Vetter and PCI Pharma are focusing on expanding their businesses, while ChemWerth has filed its 500th drug master file for clevidipine with the FDA.