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.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Slayback Pharma has succeeded in defending itself on appeal that it did not infringe certain patents shielding Eagle Pharmaceuticals’ Belrapzo rapid-infusion bendamustine product, after a district court applied the dedication-disclosure doctrine to bar the originator’s claim.

Biotech licenses drug composition patents from University of Alaska Fairbanks for study in several disease states. Gilead seeks long-acting HIV therapy or prevention with broadly neutralizing antibodies discovered by Rockefeller U.