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The company secured orphan drug designation from the US Food and Drug Administration for Epidiolex (cannabidiol or CBD) to treat IS. A two-part pivotal Phase 3 study is

The agreement is in connection with the divestiture process mandated by the US Federal Trade Commission (FTC) in relation toTeva’s $40.5bn acquisition of Allergan’s generic drugs portfolio. Impax

Under the double-blind, double-dummy, parallel group FULFIL study, 1,810 patients were randomized to receive either GSK’s fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or budesonide/formoterol. The study met its objectives, with the

Over 300 employees, investors and company partners attended the unveiling of the 43,500-square-foot, state-of-the-art plant. The facility has been designed to produce chimeric antigen receptor (CAR) and T-cell

Adaptimmune previously received orphan drug destination from the U.S. Food and Drug Administration for its NY-ESO SPEAR T-cell therapy in this indication. "While unresectable or metastatic soft tissue

The company dosed the first subject in a phase 2b double-blind, randomized, placebo-controlled trial of its norovirus vaccine candidate, TAK-214, which will target the leading cause of acute

FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016. "Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for

Ongoing quality control analysis has revealed that the stored drug product is no longer within the original specification. In discussion with the MHRA Clinical Trials Unit, and with

"Our investments reflect our ongoing commitment to growing our operational presence and export capacity in Canada," said Joseph C. Papa, chairman and chief executive officer. "Over the past