RegulationApprovals October 30, 2019 FDA grants fast track status to Terns’s FXR agonist to treat NASH By PBR Staff Writer NASH is a severe form of non-alcoholic fatty liver disease (NAFLD), which results due to the accumulation of excess fat in the liver. The disease, which is associated
RegulationApprovals October 29, 2019 EC approves Pfizer’s Bavencio plus axitinib to treat advanced RCC By PBR Staff Writer Bavencio, which is a human anti-programmed death ligand-1 (PD-L1) antibody, has been demonstrated in preclinical models to engage both the adaptive and innate immune functions. The combined therapy
RegulationMarketing Authorisation October 28, 2019 Astellas’ gilteritinib secures EC approval to treat acute myeloid leukaemia By PBR Staff Writer Gilteritinib can be used in the treatment of AML patients whose disease is in the relapsed or refractory stage, and who express a FLT3 mutation (FLT3mut+). The oral
RegulationApprovals October 25, 2019 EC approves BMS melanoma drug Opdivo two and four-week flat dosing schedule By PBR Staff Writer The FDA has approved Opdivo flat dosing schedule of 240 mg infused over 30 minutes every two weeks (Q2W) or 480 mg infused over 60 minutes every four
RegulationApprovals October 24, 2019 FDA grants expanded approval for GSK’s ovarian cancer drug Zejula By PBR Staff Writer Zejula is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor developed to treat advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three
Drug DiscoveryResearch & Development October 23, 2019 Takeda acquires TAK-101 license from COUR in $420m deal By PBR Staff Writer COUR will be eligible to receive the amount from the Japanese company in the form of future payments, and royalties on sales of any commercialised products emerging from
RegulationApprovals October 23, 2019 FDA grants fast track status to Moderna’s mRNA therapeutic to treat propionic acidemia By PBR Staff Writer Moderna has designed mRNA-3927 to instruct the body to restore the missing or dysfunctional proteins, which cause PA. PA is a rare, life-threatening and inherited a metabolic disorder
RegulationApprovals October 22, 2019 FDA approves AstraZeneca’s Farxiga to treat heart failure in diabetic patients By PBR Staff Writer The FDA approval was based on data from the DECLARE-TIMI 58 CV outcomes trial (CVOT). It is claimed to be the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CVOT
Production & SalesMarketing & Sales October 21, 2019 Bavarian Nordic to buy GSK’s rabies and tick-borne encephalitis vaccines By PBR Staff Writer Under the deal, Bavarian Nordic will purchase the manufacturing and global rights related to travel vaccines Rabipur/RabAvert to prevent rabies and Encepur to prevent TBE. The deal includes
RegulationApprovals October 18, 2019 FDA approves Roche’s Xofluza for patients at high risk of developing flu-related complications By PBR Staff Writer The FDA has approved the company’s supplemental new drug application (sNDA) for Xofluza to treat acute, uncomplicated influenza, or flu, in people 12 years of age and older