News
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Acorda Therapeutics said that it has resubmitted an NDA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson’s disease patients. The company originally submitted the 505(b)(2) application in June 2017, and… Read more . . .
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Aerogen Pharma and Lyomark Pharma have announced a partnership for development and commercialization of AP-002, a nasally-inhaled surfactant based on Lyomark’s Alveofact bovine lung surfactant for the treatment of respiratory distress syndrome (RDS) in pre-term… Read more . . .
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Sunovion’s NDA for Lonhala Magnair glycopyrrolate inhalation solution (formerly known as SUN-101/eFlow) has been approved by the FDA for the treatment of COPD, the company said. A US launch is planned in early 2018. In… Read more . . .
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Dance Biopharm announced that it has signed an agreement with Phillips-Medisize for development of a connected version of Dance’s Dance 501 insulin soft mist inhaler device. According to the announcement, Phillips-Medisize has already worked on… Read more . . .
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Glenmark Pharmaceuticals Europe said that its marketing authorization application for a generic version of Seretide Accuhaler (Advair Diskus) for the treatment of asthma and COPD has been approved through the decentralized procedure in the Nordic… Read more . . .
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Aradigm has announced that the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) will meet on January 11, 2018 to review the NDA for Linhaliq inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis… Read more . . .
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Airware Labs Corporation has entered into a non-binding letter of intent to acquire a cannabis consulting company and grower doing business as Item 9 Labs with the goal of developing an intranasal THC product, Airware… Read more . . .
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Savara has received a development award of up to $5 million from Cystic Fibrosis Foundation Therapeutics (CFFT), which will support the Phase 3 AVAIL study of the AeroVanc DPI for the treatment of MRSA lung… Read more . . .
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Novartis has announced that the FLASH study met its primary endpoint, demonstrating that switching COPD patients from Seretide (Advair) salmeterol/fluticasone Ultibro Breezhaler (Utibron Neohaler) indacaterol/glycopyrronium significantly improved lung function. The safety and tolerability of both… Read more . . .
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Bayer has announced the failure of the Phase 3 INHALE study of Amikacin Inhale inhalation solution for the treatment of gram-negative pneumonia in intubated and mechanically ventilated patients with Gram-negative pneumonia to demonstrate superiority in… 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