RegulationRejections July 27, 2018 FDA advisory committee votes against approving GSK’s mepolizumab to treat COPD By PBR Staff Writer GSK said the committee voted on the basis of data presented that the risk-benefit profile was not adequate to support approval In addition, the committee noted that there
Clinical TrialsHuman Trials July 27, 2018 Destiny Pharma’s XF-73 succeeds in phase 1 skin irritation study By PBR Staff Writer The trial is one of the two phase 1 safety clinical studies of the drug examining its potential to cause dermal irritation. XF-73 is Destiny Pharma’s lead candidate
Production & SalesManufacturing July 25, 2018 Pfizer to construct sterile injectable pharmaceutical production plant in Michigan, US By PBR Staff Writer The company will build the new multi-storey and 400,000ft² production facility in Portage, situated in Kalamazoo County. Named as modular aseptic processing (MAP), the new production facility will
News July 1, 2018 Roche’s Tecentriq plus chemo meets PFS goal in triple negative breast cancer By PBR Staff Writer The chemotherapy used in combination with Tecentriq is Abraxane [albumin-bound paclitaxel; nab-paclitaxel]). The late-stage trial dubbed IMpassion130 was found to have reduced the risk of disease worsening or
News June 29, 2018 Sanofi, Advent finalize negotiations for acquisition of Zentiva By admin The companies announced that they had entered into exclusive talks on April 17, 2018. The signing of this Share Purchase Agreement marks a critical step on the way
News June 29, 2018 Arsanis to discontinue phase 2 trial of pneumonia drug over futility By admin Based on the results of this analysis, the DRC determined that the trial was futile, meaning that it was not likely to meet its primary end-point upon completion