Drug DiscoveryResearch & Development August 9, 2018 Takeda collaborates with Ambys on liver disease therapies By PBR Staff Writer The partnership announcement coincided with official launch of Ambys Medicines with a $60m Series A financing funded by Third Rock Ventures and Takeda. The partnership with Takeda brings
RegulationApprovals August 2, 2018 Pfizer secures European approval for Xeljanz to treat ulcerative colitis By PBR Staff Writer The marketing authorization has been granted for Xeljanz10 mg twice-daily (BID) for at least eight weeks, followed by Xeljanz 5mg BID or 10 mg BID, to treat adult
Production & SalesManufacturing August 1, 2018 LEO Pharma to buy Bayer’s prescription dermatology brands By PBR Staff Writer Included in the acquisition are branded topical prescription treatments for acne, fungal skin infections and rosacea, along with a variety of topical steroids, which had an annual turnover
Production & SalesManufacturing August 1, 2018 Amgen breaks ground on $200m biomanufacturing facility in US By PBR Staff Writer The company expects to invest up to $200m in the approximately 120,000ft² biomanufacturing plant at its West Greenwich campus in Rhode Island. Amgen will use its next-generation biomanufacturing
RegulationApprovals July 31, 2018 Progenics’ Azedra gets FDA approval for rare adrenal gland tumors By PBR Staff Writer The approval is for the intravenous use of the Azedra injection in patients whose adrenal gland tumors are unresectable and have spread beyond the original tumor site and
Clinical TrialsHuman Trials July 31, 2018 RedHill’s RHB-104 meets primary endpoint in phase III Crohn’s disease study By PBR Staff Writer The company has announced the positive top-line safety and efficacy results from the MAP US study, which showed superiority of RHB-104 over placebo. RHB-104 is a proprietary and
RegulationMarketing Authorisation July 30, 2018 European Commission grants marketing authorization for Sandoz’ biosimilar Hyrimoz By PBR Staff Writer It is the fourth Sandoz biosimilar approved in Europe in past 18 months, and seventh in total. Hyrimoz is an inhibitor of tumor necrosis factor (TNF), a protein
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