News
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Nuance Pharma announced that the Hong Kong Drug Office has approved Ohtuvayre ensifentrine inhalation suspension for the treatment of COPD. According to Nuance, Ohtuvarye had been available through certain medical facilities in Macau and Hong Kong… Read more . . .
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Orbia Fluor & Energy Materials (previously Koura, Mexichem) has announced the submission of a drug master file for its HFA 152a MDI propellant, marketed as Zephex 152a. The company kicked off the transition to low global warming potential… Read more . . .
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Chiesi and Inhalation CDMO Bespak have announced an expansion of an existing partnership to increase manufacturing capacity for LGWP propellant MDIs at Bespak’s Holmes Chapel, UK site. Chiesi announced plans to launch an HFA 152a inhaler by… Read more . . .
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US-based CDMO Kenox Pharmaceuticals announced that it is now able to offer clinical manufacturing for OINDPs and has expanded its testing services for OINDPs, including in vitro BE. In January 2025, the company said that it… Read more . . .
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Glenmark’s generic equivalent of FloVent HFA fluticasone propionate MDI gets final approval from FDA
According to Glenmark, the FDA has approved the company’s ANDA for a generic equivalent of GSK’s FloVent HFA fluticasone propionate MDI with competitive generic therapy (GGT) designation. FloVent HFA was initially approved in 2004, and… Read more . . .
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Rein Therapeutics announced the that the first patient has been dosed in a Phase 2 study evaluating its LTI-03 caveolin-1 scaffolding domain peptide DPI in patients with idiopathic pulmonary fibrosis, with interim data expected later… Read more . . .
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AtaiBeckley said that it completed an End‑of‑Phase 2 meeting with the FDA regarding BPL‑003 intranasal mebufotenin for the treatment of treatment‑resistant depression (TRD) and that the agency indicated that it supports the company’s plan for… Read more . . .
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US biopharm Esperion will pay $75 million in cash up front and up to $180 million in milestone payments to acquire Corstasis Therapeutics and its Enbumyst bumetanide nasal spray, the companies said. The deal also… Read more . . .
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According to Pulmatrix, Cullgen has terminated the 2024 merger agreement between the companies. Pulmatrix said that it would In December 2025, Pulmatrix and Cullgen announced that Chinese authorities had still not approved the merger, and… Read more . . .
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SpliSense’s SPL84 inhaled antisense oligonucleotide for CF gets early PRIME designation from the EMA
According to SpliSense, the European Medicines Agency has granted early Priority Medicines designation to the company’s SPL84 inhaled antisense oligonucleotide for the treatment of cystic fibrosis in patients with a 3849+10Kb C>T mutation in the… 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