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Janssen Pharmaceuticals Inc.

www.janssenpharmaceuticalsinc.com

Latest From Janssen Pharmaceuticals Inc.

EU Accelerated Assessment Tracker

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.

Europe Review Pathway

Expanded Distribution For COVID Vaccines Will Boost Options – And Logistical Complications

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.

Coronavirus COVID-19 Vaccines

Incyte, TG's PI3K Inhibitors Show Safety Advantage In Indolent NHL

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.

BioPharmaceutical Cancer

Loxo Lays Out Plans For BTK Inhibitor LOXO-305 In CLL

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

BioPharmaceutical Business Strategies
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