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Dupixent (dupilumab) / Sanofi, RegeneronFDA Grants Dupixent (dupilumab) Breakthrough Therapy Designation for Eosinophilic Esophagitis (PRNewswire) - Sep 14, 2020 - "Regeneron Pharmaceuticals, Inc....and Sanofi today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent® (dupilumab) for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE). The designation for this investigational use is based on positive results from Part A of a Phase 3 trial in patients with EoE."Ongentys (opicapone) / Ono Pharma, NeurocrineNeurocrine Biosciences Announces Once-Daily ONGENTYS (opicapone) Now Available in the U.S. as an Add-On Treatment for Patients with Parkinson's Disease Experiencing 'Off' Episodes (PRNewswire) - Sep 14, 2020 - " Neurocrine Biosciences, Inc....today announced that 50 mg capsules of ONGENTYS® (opicapone), the first and only FDA-approved once-daily catechol-O-methyltransferase (COMT) inhibitor, are now available by prescription in the United States....The FDA approval of ONGENTYS is supported by data from 38 clinical studies, including two multinational Phase III clinical studies (BIPARK-1 and BIPARK-2), with more than 1,000 Parkinson's disease patients treated with ONGENTYS."APO-go (apomorphine continuous subcutaneous infusion) / Stada, Kyowa Hakko Kirin, Endo, SupernusSupernus Submits NDA for SPN-830 for Continuous Treatment of ON-OFF Episodes in Adults with Parkinson’s Disease Who Have Failed Two Treatments (GlobeNewswire) - Sep 14, 2020 - "Supernus Pharmaceuticals, Inc....today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its apomorphine infusion pump (SPN-830) for the continuous treatment of ON-OFF episodes in adults with Parkinson’s disease (PD)....The NDA for SPN-830 is based on data from an extensive development program, completed by Supernus’ partners, US WorldMeds, LLC and Brittania Pharmaceuticals Ltd. The program includes the TOLEDO study..."Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex; Kalydeco (ivacaftor) / VertexVertex Announces European Medicines Agency Type II Variation Marketing Authorization Application Validation for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in Combination with ivacaftor in People with One Copy of the F508del Mutation (Businesswire) - Sep 14, 2020 - "Vertex...today announced the European Medicines Agency (EMA) has validated a Type II Variation Marketing Authorization Application (MAA) for the expanded indication of KAFTRIO®* (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat CF in patients ages 12 years and older with at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene...The MAA is supported by positive results from the global Phase 3 study (445-104) with KAFTRIO...The application will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP), which will issue an opinion to the European Commission regarding the potential approval for these patients."EPI-7386 / ESSA PharmaESSA Pharma Announces Fast Track Designation Granted by the FDA to EPI-7386 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (PRNewswire) - Sep 14, 2020 - “ESSA Pharma Inc…announced that the U.S. Food and Drug Administration ('FDA') granted Fast Track Designation to EPI-7386, its oral and highly-selective N-terminal domain inhibitor of the androgen receptor, for the treatment of adult male patients with metastatic castration-resistant prostate cancer ('mCRPC') resistant to standard-of-care treatment.”
