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mexiletine / Generic mfg., TevaUS FDA grants mexiletine Orphan Drug Designation (GlobeNewswire) - Jun 8, 2020 - "Lupin is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to mexiletine hydrochloride for the treatment of myotonic disorders."brensocatib (INS1007) / InsmedInsmed receives FDA Breakthrough Therapy Designation for brensocatib in patients with non-cystic fibrosis bronchiectasis (NCFBE) (PRNewswire) - Jun 8, 2020 - "Insmed Incorporated...today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for brensocatib (formerly known as INS1007) for the treatment of adult patients with non-cystic fibrosis bronchiectasis (NCFBE) for reducing exacerbations....The breakthrough therapy designation for brensocatib is based on positive results from the global randomized, double-blind, placebo-controlled Phase 2 WILLOW study of brensocatib in adults with NCFBE....Insmed expects to initiate a Phase 3 program for brensocatib in bronchiectasis in the second half of 2020."Qinlock (ripretinib) / DecipheraDeciphera announces publication of the INVICTUS pivotal phase 3 study of Qinlock (ripretinib) in The Lancet Oncology (Businesswire) - Jun 8, 2020 - P3, N=129; invictus (NCT03353753); Sponsor: Deciphera Pharmaceuticals LLC; "Deciphera Pharmaceuticals, Inc…announced that The Lancet Oncology has published results from the INVICTUS pivotal Phase 3 study of QINLOCK in patients with fourth-line gastrointestinal stromal tumor (GIST). The INVICTUS study met its primary endpoint, demonstrating a statistically significantly improvement in progression free survival (PFS) in patients randomized to QINLOCK compared with patients receiving placebo. The safety profile observed in INVICTUS was consistent with previously published results..."Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo PharmaValeo Pharma receives approval from Health Canada for the transfer of commercial rights to Yondelis in Canada (Canada Newswire) - Jun 8, 2020 - "Valeo Pharma Inc…announced today that it has received a Notice of Compliance from Health Canada authorizing the transfer of the commercial rights of Yondelis® to Valeo. Yondelis® (trabectedin) is a novel marine-derived antitumor agent manufactured by PharmaMar S.A., based in Madrid, Spain…'With the receipt of Health Canada's approval, Valeo can now assume the commercialization of Yondelis® in Canada. Yondelis® is an important treatment option for patients with soft tissue sarcoma…'Yondelis® is the first of five product approvals and launches that we anticipate over the second half of the year."Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGenRoxadustat demonstrates non-inferiority to darbepoetin in phase 3 DOLOMITES study of anemia in non-dialysis-dependent adult patients with chronic kidney disease (Astellas Press Release) - Jun 8, 2020 - P3, N=616; DOLOMITES (NCT02021318); Sponsor: Astellas Pharma; "The data presented during an oral presentation at the 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress, taking place between June 6–9, 2020, showed non-inferiority of roxadustat to darbepoetin alfa in the correction of hemoglobin levels during the first 24 weeks of treatment (89.5% vs 78.0%; a difference of 11.51% [95% confidence interval (Cl): 5.66%, 17.36%]), meeting the study’s primary endpoint with a lower bound of the 95% CI >0."
