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llllllllll azacitidine oral (CC-486) / BMSU.S. Food and Drug Administration Approves Onureg (azacitidine tablets), a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia (Businesswire) - Sep 1, 2020 - "Bristol Myers Squibb...today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy...The approval is based on results from the pivotal Phase 3 QUAZAR® AML-001 study..." llllllllll Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex; Kalydeco (ivacaftor) / Vertex; Symdeko (tezacaftor/ivacaftor) / VertexFDA Accepts Vertex’s Supplemental New Drug Applications for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO (tezacaftor/ivacaftor and ivacaftor) and KALYDECO (ivacaftor) for Additional CFTR Mutations (Businesswire) - Sep 1, 2020 - "Vertex...today announced the U.S. Food and Drug Administration (FDA) accepted three supplemental New Drug Applications (sNDAs) for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor)...The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2020. The regulatory submissions are based on data from an in vitro cell assay showing that these rare CFTR mutations respond to one or more of these CFTR modulator regimens." llllllllll Oraxol (oral paclitaxel/encequidar) / AthenexAthenex Announces FDA Acceptance for Filing of U.S. NDA for Oral Paclitaxel and Encequidar in Metastatic Breast Cancer with Priority Review (GlobeNewswire) - Sep 1, 2020 - "Athenex, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer and has granted the application Priority Review…Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of February 28, 2021. Additionally, the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application….The Oral Paclitaxel NDA submission is supported by data from a single pivotal Phase III study of Oral Paclitaxel for the treatment of metastatic breast cancer." llllllllll MetaBlok (lsalt peptide) / Arch BiopartnersArch Biopartners Announces Application to the Turkish Ministry of Health to Conduct Phase II Trial for Treatment of Complications in COVID-19 patients (GlobeNewswire) - Sep 1, 2020 - "Arch Biopartners Inc....today announced that applications to the Turkish Ministry of Health and local Ethics Committee have been submitted to obtain permission to recruit COVID-19 patients in Turkey for the Phase II trial....Arch is planning to expand the existing Phase II trial about to begin in the U.S. by adding hospital sites in İstanbul and Ankara, Turkey....Progress toward the start of the trial continues in the U.S. with the dosing of the first patient expected to occur this month. Recruitment of patients in Turkey will follow once the trial has been approved by the Turkish regulatory authorities, expected during the month of September." llllllllll Imfinzi (durvalumab) / AstraZenecaImfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer (AstraZeneca Press Release) - Sep 1, 2020 - "AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin...The approval by the European Commission was based on positive results from the Phase III CASPIAN trial..."
