FDA grants orphan drug status to Anavex 2-73 to treat infantile spasms
It gives Anavex a seven year window of commercial exclusivity in the US in the area of infantile spasms, prioritized consultation by the FDA on clinical studies and
THX Pharma (Theranexus) and Biocodex have entered a strategic licensing agreement to further the development of two drug candidates, Batten-1 and TX01, targeted at the Batten, Gaucher, and Niemann-Pick type C rare diseases.
The final agreement will be signed, inter alia, subject to the completion of an initial clinical trial in the technology to the satisfaction of Therapix, and the completion
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