Month Year
Su | Mo | Tu | We | Th | Fr | Sa |
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Month Year
Su | Mo | Tu | We | Th | Fr | Sa |
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Mar 27, 2019
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Feb 22, 2019--ARIKAYCE® (amikacin liposome inhalation suspension) U.S. Net Product Sales of $9.2 Million for the Fourth Quarter and Full Year 2018--
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Jan 4, 2019-ARIKAYCE Preliminary Unaudited U.S. Net Product Sales Approximately $9.2 Million for the Fourth Quarter of 2018-
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Nov 8, 2018—Seasoned Pharmaceutical Executive Elizabeth McKee Anderson Appointed as New Director—
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Nov 6, 2018
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Oct 30, 2018—Quarter Highlighted by U.S. FDA Approval of ARIKAYCE® (amikacin liposome inhalation suspension), Followed by Immediate Launch—
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Oct 4, 2018New Patent Adds 7 ½ Years of Market Exclusivity in Japan
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Oct 1, 2018
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Sep 28, 2018Commercial availability expected in early Q4 2018
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Sep 17, 2018As previously reported, study met primary endpoint of culture conversion (p<0.0001)
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Aug 27, 2018Advisory committee supports surrogate endpoint of sputum culture conversion
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Aug 2, 2018PDUFA (Prescription Drug User Fee Act) Action Date for ALIS (Amikacin Liposome Inhalation Suspension) Set for September 28, 2018
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Jun 15, 2018Meeting planned for August 7, 2018
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Jun 7, 2018
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May 22, 2018Data support the benefit of treating patients with a combination of ALIS (Amikacin Liposome Inhalation Suspension) and guideline-based therapy (GBT) for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC)
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May 17, 2018
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May 16, 2018PDUFA Action Date Set for September 28, 2018
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May 2, 2018Submitted NDA to FDA for Amikacin Liposome Inhalation Suspension (ALIS) in NTM lung disease caused by MAC; anticipates priority review
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Mar 29, 2018ALIS previously designated as an orphan drug, breakthrough therapy and Qualified Infectious Disease Product (QIDP)
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Feb 23, 2018On track to file NDA before the end of March and anticipate a priority review
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Jan 26, 2018
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Jan 3, 2018Interim results from INS-312 show that 28% of patients who previously received 6 months of guideline based therapy (GBT) alone achieved culture conversion following addition of ALIS to therapy, consistent with data from the INS-212 study
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Nov 8, 2017
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Nov 2, 2017During the third quarter, the Company announced positive top-line results from its Phase 3 CONVERT Study of ALIS (amikacin liposome inhalation suspension) in patients with NTM lung disease caused by MAC, a rare, progressive, destructive lung infection
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Sep 11, 2017
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Sep 5, 2017Study met primary endpoint of culture conversion (p < 0.0001)