Calls for papers
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DPI developer Iconovo said that the FDA “has issued a positive guidance regarding the generic substitutability of the company’s proprietary inhaler ICOpre with the original drug Breo Ellipta with respect to external design and operating… Read more . . .
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The FDA and AstraZeneca are both touting the agency’s approval of FluMist intranasal influenza vaccine for caregiver administration to children aged 2-17 and for self-administration by adults up to age 49. The agency agreed to… Read more . . .
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The FDA has advised California-based Green Pharmaceuticals to recall its SnoreStop nasal spray due to “significant microbial contamination in SnoreStop Nasal Spray lot number 2460” detected during an inspection in April 2024 and is warning… Read more . . .
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Tiziana Life Sciences announced that a study of the company’s intranasal anti-CD3 mAb will be funded by a $4 million grant from the National Institutes of Health. In June 2024, the company said that the… Read more . . .
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Pulmotect announced that it has raised $5.9 million in a Series C funding to support a Phase 2 trial of the company’s PUL-042 immunostimulant inhalation solution. According to Pulmotect, the new funds will be used… Read more . . .
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MannKind Corporation announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the initiation of the Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease. The company noted… Read more . . .
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UK-based Synairgen, which is developing SNG001 inhaled interferon-beta-1a, announced that former Chiesi Global Head of Drug Development Mark Parry-Billings will succeed Simon Shaw as Chairman of the Board. Shaw will retire in October 2024. Prior to… Read more . . .
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CDMO Ritedose Corporation announced that it will manufacture Verona Pharma’s Ohtuvayre nebulized ensifentrine, which was approved by the FDA in June 2024 for the treatment of COPD. Also in June 2024, Ritedose announced that it… Read more . . .
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CDMO Serán Bioscience announced “a strategic growth transaction” led by Bain Capital Life Sciences that is worth more than $200 million, with the funds intended to support completion of a new commercial-scale manufacturing facility in… Read more . . .
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Inhalation CDMO Vectura has been sold to Molex for £150 million up front and up to an additional £148 million in potential payments, the companies have announced. Following the acquisition, Vectura will be operated by Phillips… Read more . . .

Upcoming Events
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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
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden

