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Ziextenzo (pegfilgrastim biosimilar) / Novartis; Rixathon (rituximab biosimilar) / Kyowa Hakko Kirin, NovartisSandoz Canada receives Health Canada approval to launch two oncology biosimilars: Ziextenzo and Riximyo (GlobeNewswire) - Jun 9, 2020 - "Sandoz Canada...announced today that Health Canada has approved Ziextenzo® (pegfilgrastim, reference biologic drug: Neulasta®) and Riximyo® (rituximab, reference biologic drug: Rituxan®) for marketing in Canada. Sandoz Canada received a Notice of Compliance from Health Canada on April 21, 2020, for the use of Ziextenzo® to reduce the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy. Riximyo® was approved on April 28, 2020, to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis."plinabulin (BPI 2358) / BeyondSpring; Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, RocheBeyondSpring’s PROTECTIVE-2 (Study 106) phase 2 trial for chemotherapy-induced neutropenia shows positive results in chemotherapy optimization with potentially better clinical outcomes (GlobeNewswire) - Jun 9, 2020 - P3, N=222; PROTECTIVE-2 (NCT03294577); Sponsor: BeyondSpring Pharmaceuticals Inc; "BeyondSpring...announced that its PROTECTIVE-2 (Study 106) Phase 2 superiority trial for chemotherapy-induced neutropenia (CIN) shows that the Company’s lead asset, Plinabulin, in combination with Neulasta, enables more cancer patients to receive the optimal chemotherapy dose and regimen, which potentially leads to better clinical outcomes....Dose reduction (over 15 percent): Only 6.3 percent of patients in the Plinabulin-Neulasta combination arm versus 22.7 percent in Neulasta arm – a 72 percent improvement"Luveniq (voclosporin) / Aurinia PharmaAurinia presents additional AURORA pivotal trial safety data at the ERA-EDTA Virtual Congress 2020 (Businesswire) - Jun 9, 2020 - P3, N=358; AURORA (NCT03021499); Sponsor: Aurinia Pharmaceuticals Inc.; "Aurinia Pharmaceuticals Inc....announced that additional safety data from the completed AURORA pivotal trial of voclosporin were shared at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 Virtual Congress....The data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin group and 10.2% in the control arm (p=0.971)....'This data has been submitted to the FDA as part of voclosporin’s recently completed New Drug Application.'"NanoPac (paclitaxel nanoformulation) / NanOlogyNanOlogy announces initiation of a lung cancer clinical trial following FDA allowances of two IND applications for NanoPac in lung cancer (Businesswire) - Jun 9, 2020 - "NanOlogy, LLC...announced...initiation of a clinical trial of IT NanoPac® (submicron particle paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in NSCLC and SCLC. The trial follows FDA allowance of an investigational new drug (IND) application for IT NanoPac in neoplasms of the lung. A second IND was also allowed by FDA for a nebulized inhaled form of NanoPac in NSCLC....The first study to proceed will be a Phase 2a dose-rising and expansion trial (NCT04314895) evaluating the safety and tolerability of up to 3 monthly IT injections of NanoPac delivered via EBUS-TBNI, concurrent with standard of care therapy, in patients with primary or recurrent NSCLC or SCLC."Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, OtsukaHelsinn announces launch of oral formulation of Akynzeo in China (GlobeNewswire) - Jun 9, 2020 - "Helsinn...announce that the oral formulation of Akynzeo® for the treatment of chemotherapy-induced nausea and vomiting (CINV) has been launched in China."
