Drug Industry Daily

View the entire issue.

The FDA is asking a federal judge to dismiss a lawsuit brought by six agency scientists who say they were subjected to retaliatory personnel actions as punishment for reporting product safety concerns to Congress and the U.S. Office of Special Counsel (OSC).

The FDA has outlined its checklist of requirements that drugmakers submitting Type II active pharmaceutical ingredient (API) drug master files (DMF) must meet before the files are listed on the agency’s public website as available for reference to support an ANDA.

In the pharma giant’s first foray into the new drug class, J&J has agreed to pony up close to $1 billion to develop and market a promising Janus Kinase (JAK) inhibitor discovered by Astellas.

Takeda Pharmaceutical and Lundbeck have submitted an NDA for vortioxetine to treat major depressive disorder (MDD) in adult patients.

Genzyme’s Phase III trial of eliglustat tartrate to treat Gaucher’s disease Type 1 has met its endpoint, setting the company up for a filing in the fourth quarter.