News
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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the reclassification of Nasonex mometasone furoate nasal spray from a “POM,” or “prescription only medicine,” to a “P” medicine, available over the counter at… Read more . . .
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Sunovion has announced that it has agreed to divest US rights to the Alvesco ciclesonide MDI for the treatment of asthma and the Omnaris and Zetonna ciclesonide nasal sprays for the treatment of allergic rhinitis… Read more . . .
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MannKind Corporation has announced the appointment of Patrick McCauley as Chief Commercial Officer, effective immediately. McCauley was most recently Area VP, West US, Urulogy/PCP Sales for Astellas Pharma and had served in various sales and… Read more . . .
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During a July 11, 2017 meeting between AstraZeneca CEO Pascal Soriot and Australian Prime Minister Malcolm Turnbull, Soriot announced an A$100 million expansion of the company’s manufacturing facility in Sydney, which he called “really a… Read more . . .
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Functional respiratory imaging (FRI) specialist Fluidda has requested a Critical Path Innovation Meeting (CPIM) with the FDA as part of an initiative for approval of its FRI technology as a biomarker, the company said. According… Read more . . .
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Savara Pharmaceuticals has presented interim results from a Phase 2 study of Aironite sodium nitrite inhalation solution for the treatment of pulmonary hypertension at the 4th Annual Drug Discovery and Development Symposium for Pulmonary Hypertension.… Read more . . .
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Lonza’s acquisition of CDMO Capsugelfrom KKR for $5.5 billion, which was initially announced in December 2016, is now complete, the company said. In 2011, Pfizer sold Capsugel to KKR for just under $2.4 billion, and… Read more . . .
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The FDA has accepted for review Sunovion’s resubmission of the NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD, the company said. Sunovion received a complete response letter to the previously submitted NDA… Read more . . .
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Windtree Therapeutics has announced that its Phase 2b clinical trial of Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants receiving nasal continuous positive airway pressure (nCPAP) failed to… Read more . . .
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Acorda Therapeutics has submitted a 505(b)(2) new drug application for Inbrija (CVT-301) levodopa for the treatment of symptoms during OFF periods in Parkinson’s disease patients, the company said. According to the company, the FDA is… 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