Clinical TrialsHuman Trials January 23, 2019 Redx gets regulatory nod to restart RXC004 clinical trial By PBR Staff Writer An oral porcupine inhibitor, RXC004 has been designed to target the Wnt signaling pathway. The early-stage trial of the small molecule drug was temporarily stopped in March 2018
Drug DiscoveryResearch & Development January 21, 2019 Kyn Therapeutics, Celgene partner on immuno-oncology therapies development By PBR Staff Writer The collaboration will combine the immuno-oncology expertise and pipeline of Kyn Therapeutics with the capabilities of Celgene in development and commercialization of drugs in areas of high unmet
Packaging & Supply ChainPackaging January 17, 2019 Schott to invest €300m in pharmaceutical packaging buisness By PBR Staff Writer Through the investment, Schott plans to expand its primary business of glass tubing, used as the starting material for pharmaceutical packaging, and also pharmaceutical packaging made of glass and
RegulationDrug Filing January 16, 2019 Silence’s SLN124 gets orphan designation in Europe for β-Thalassemia By PBR Staff Writer The designation to SLN124 was granted by the Committee for Orphan Medicinal Products (COMP), a committee of the European Medicines Agency (EMA). COMP after reviewing an application filed
RegulationDrug Filing January 15, 2019 Pfizer’s tafamidis secures FDA priority review for ATTR-CM By PBR Staff Writer The pharma giant filed two new drug applications (NDAs) with the regulator covering the two forms of tafamidis – meglumine salt and free acid. The company said that
Production & SalesMarketing & Sales January 10, 2019 Eusa Pharma acquires iMCD treatment Sylvant for $115m By PBR Staff Writer Sylvant secured approval in over 40 countries to treat idiopathic multicentric Castleman’s disease (iMCD), which is a subtype of Castleman disease or giant lymph node hyperplasia, lymphoid hamartoma,
RegulationApprovals January 9, 2019 Novartis gets breakthrough therapy status for sickle cell disease treatment crizanlizumab By PBR Staff Writer Crizanlizumab (SEG101) is a humanized anti-P-selectin monoclonal antibody being studied to restrict VOCs in SCD. The status has been provided based on positive data from the phase II
Production & SalesManufacturing January 8, 2019 Catalent to invest $200m in biologics business By PBR Staff Writer Catalent will use the investment to enhance drug substance manufacturing capacity and drug product fill/finish capacity at its biologics manufacturing sites in Madison of Wisconsin and Bloomington of
Drug DiscoveryResearch & Development January 7, 2019 Gilead, Yuhan to co-develop new therapies for NASH in $785m deal By PBR Staff Writer As per the agreement, US-based Gilead will buy worldwide rights, with the exception of South Korea, to develop and commercialize novel small molecules against two undisclosed targets. In
Clinical TrialsHuman Trials January 4, 2019 Pfizer begins phase 2b/3 trial of PF-06651600 to treat alopecia areata By PBR Staff Writer Alopecia areata is a chronic autoimmune skin disease, which makes hair loss on the scalp, face and body. At present, there are no approved therapies for this autoimmune