Bayer has failed to convince the European Medicines Agency that its marketing authorization application for finerenone should be fast-tracked through the EU's centralized review process. There were other successes, though, although Janssen is keeping us guessing over its MAA for amivantamab. These and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.

Operation Warp Speed officials eye the Moderna vaccine and upcoming one-shot Janssen product to widen the immunization campaign’s reach, but more products also could bring more problems.

Neither TG's UNITY-NHL nor Incyte's CITADEL-203 study reported any fatal adverse events - a problem for which Gilead and Verastem's PI3K inhibitors carry boxed warnings.

The company said investigators had been choosing the drug over Venclexta due to its less cumbersome administration, especially amid the COVID-19 pandemic.