News
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Aradigm has submitted a marketing authorization application to the EMA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. In… Read more . . .
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A Type II variation application for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI in patients whose asthma is adequately controlled by an ICS/LABA combination has been approved by the EC, according to GSK… Read more . . .
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CDMO Hovione has announced results from a total of 8 inspections at its manufacturing sites in 2017 as part of a new transparency effort. The report covers pre-approval, GMP, and surveillance inspections by regulators from… Read more . . .
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Swiss CDMO Micro-Sphere has announced the completion of a successful GMP inspection by Swissmedic of its facility in Lugano, Switzerland, which recently added to its spray drying and manufacturing capacity. Micro-Sphere offers a range of… Read more . . .
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MannKind Corporation has announced the initiation of a Phase 1 clinical study of its dry powder formulation of treprostinil based on its Technosphere inhaled delivery technology for the treatment of pulmonary arterial hypertension (PAH). The… Read more . . .
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Inhaler testing equipment company Copley Scientific has joined the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) as an associate member, the company said. According to IPAC-RS, “A corporation is eligible for participation in… Read more . . .
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OINDP testing specialist Proveris Scientific has spun off inhaler-specific talking guidance technology to a start up called Uneva Health, the company said. Uneva, which will be led by former Proveris President Sue Farina, is raising… Read more . . .
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Less than a week after GSK Canada said that it had recalled a lot of Ventolin Diskus in Canada due to “a manufacturing issue that may result in a small number of Ventolin Diskus devices… Read more . . .
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Novi Systems has announced the launch of the DecaVision imaging module for its DecaVertus system, which can be configured for shake and fire testing of up to 10 pressurized metered dose inhalers at a time.… Read more . . .
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Results from the CLAIM study published online in Lancet Respiratory Medicine on February 21, 2018 show that COPD patients using Novartis’s Ultibro Breezhalerindacaterol/glycopyrronium DPI had significantly decreased lung hyperinflation and improved cardiac function after 14… Read more . . .
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