Author: Dino Mustafić

September 30, 2015 Off

FDA approves Meiji’s QIDP and Fast Track Designation to ME1100

By Dino Mustafić

Meiji Seika Pharma Co., Ltd. announced on Tuesday that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead antibiotic product, ME1100 (arbekacin inhalation solution), as a Qualified Infectious Disease Product (QIDP) for the adjunctive treatment of mechanically ventilated patients with bacterial pneumonia.

September 29, 2015 Off

Eli Lilly, Incyte: positive top-line results of RA-BEGIN

By Dino Mustafić

Eli Lilly and Company and Incyte Corporation have announced positive top-line results of RA-BEGIN, the third Phase 3 study evaluating the safety and efficacy of baricitinib, an investigational medicine for patients with moderately-to-severely active rheumatoid arthritis (RA).