News
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Savara has announced that the Phase 2 INDIE study of Aironite sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) failed meet its primary endpoint and, as a result,… Read more . . .
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Inhaled insulin developer Dance Biopharm has announced that Diplomat Specialty Pharmacy Chairman Benjamin Wolin has joined its board of directors. In 2002, Wolin co-founded digital marketing company Everyday Health and led the company until its… Read more . . .
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According to Hikma Pharmaceuticals, the FDA has concluded the dispute resolution process regarding HIkma’s ANDA for its generic version of the Advair fluticasone propionate/salmeterol DPI and has requested a new clinical study. The FDA issued… Read more . . .
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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 . . .
Upcoming Events
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July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan
September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA