News
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Irish biopharm company GH Research said that it has completed inhalation toxicology studies of GH001 inhaled mebufotenin (5-MeO-DMT) necessary to address the FDA’s 2023 clinical hold on an IND that the company had submitted for a… Read more . . .
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Intranasal vaccine developer Leyden Laboratories announced the closing of a $70 million funding round, with proceeds going to support development of prophylactic nasal sprays based on the company’s “Mucosal Protection Platform.” Leyden Labs, which initiated… Read more . . .
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Aer Therapeutics has announced the initiation of the AER-01-002 Phase 2a proof-of-concept study of nebulized fexlamose (formerly AER-01) in COPD patients with high mucus plug scores. The trial is expected to enroll 100 patients with… Read more . . .
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Qnovia (formerly Respira Technologies) has announced the initiation of a Phase 1 PK study of its QN-01 inhaled nicotine, which is delivered via the company’s RespiRx vibrating mesh inhaler. In October 2024, Qnovia announced that the… Read more . . .
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Phillips Medisize announced that its parent company Molex has completed its acquisition of inhalation CDMO Vectura, which was initially announced in September 2024. According to the announcement, the acquisition covers all of Vectura’s assets in… Read more . . .
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Arcturus Therapeutics announced that it initiated 2 studies in December 2024, one of which is a Phase 2 MAD trial of ARCT-032 inhaled mRNA therapy in cystic fibrosis patients. The company announced in September 2024 that… Read more . . .
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ARS Pharmaceuticals announced that it has submitted marketing applications for neffy epinephrine (adrenalin) nasal spray in Canada and in the UK. The nasal spray has been approved in the US and in Europe (as EURneffy) for the… Read more . . .
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Endo USA has recalled all unexpired lots of Adrenalin Chloride Solution epinephrine nasal solution, which is meant for topical application, due to FDA concerns about the potential for confusion of the product with the company’s… Read more . . .
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Aridis Pharmaceuticals said that “an undisclosed pharmaceutical company” has agreed to pay $6.5 million plus annual royalty payments for Aridis’ AR-501 nebulized gallium for the treatment of chronic lung infections in patients with cystic fibrosis.… Read more . . .
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The US Court of Appeals for the Federal Circuit has upheld a ruling from district court that requires Teva to remove patents covering inhaler device and dose counter IP from the FDA’s Orange Book. 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