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
Production & SalesMarketing & Sales October 16, 2019 Acino to buy Takeda’s select OTC and prescription pharmaceutical assets for $200m By PBR Staff Writer The divestment is part of Takeda’s strategy to focus on core business areas and facilitate rapid deleveraging following its acquisition of Shire. Takeda growth and emerging markets business
RegulationApprovals October 15, 2019 Janssen, Bayer get FDA nod for Xarelto to prevent VTE in acutely ill medical patients By PBR Staff Writer The approval has been granted for Xarelto to prevent venous thromboembolism (VTE) or blood clots in hospitalised acutely ill medical patients at risk for thromboembolic complications who are
RegulationApprovals October 14, 2019 Eli Lilly gets FDA approval for migraine drug Reyvow By PBR Staff Writer Reyvow is a new oral medication for the acute treatment of migraine, with or without aura, in adults. It binds to 5-HT1F receptors with high affinity. Reyvow is