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news.GW Pharmaceuticals selects infantile spasms for Epidiolex development program
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 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
ASF-1096 is a phase II product candidate that Cipher is investigating as a treatment for selected inflammatory skin disorders. Cipher acquired the global rights to the product in
The manufacturing company is vertically integrated and manufactures these and other products from active pharmaceutical ingredient (API) to finished dosage forms. The manufacturer has USFDA and EU approved
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
Oracle Health Sciences InForm Cloud Service and the Oracle Siebel Clinical Trial Management and Monitoring Cloud Service will help the pharmaceutical firm in managing and monitoring in over
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