News
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Pulmatrix has announced that topline data from a Phase 1b study of its PUR1800 dry powder narrow spectrum kinase inhibitor in COPD patients showed that inhaled PUR1800 produced “low and consistent systemic exposure” with “no… Read more . . .
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According to Perrigo, the FDA has approved its NDA for Nasonex 24HR Allergy mometasone furoate nasal spray for the treatment of allergy symptoms, the first branded Rx-to-OTC switch for Perrigo, and the company expects to launch… Read more . . .
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RDD 2022 (May 1-5 in Orlando, Florida) will be the first major OINDP meeting to take place primarily in person since the beginning of the COVID-19 pandemic. According to Richard Dalby of RDD Online, organizers… Read more . . .
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TFF Pharmaceuticals said that the company has entered into an additional Cooperative Research and Development Agreement (CRADA) with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Geneva Foundation for formulation of an intranasal dry powder… Read more . . .
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The FDA has approved a generic version of AstraZeneca’s Symbicort budesonide / formoterol fumarate MDI from Mylan (now Viatris), the agency announced. The FDA tentatively approved the Mylan ANDA in March 2021 just after a… Read more . . .
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Declaring that it is “determined to grow its portfolio in the complex generics space,” Novartis generics division Sandoz announced its acquisition of device device developer Coalesce Product Development. Coalesce’s inhaler technology include MDI, breath-actuated MDI,… Read more . . .
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Researchers from the University of Liverpool have partnered with nebulizer maker Aerogen on a project called “Treatment of Respiratory Infections with inhaled AntimicrobiaLs” (TRIAL), which will develop inhaled therapies for the treatment of bacterial and… Read more . . .
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Inhaler monitoring company Adherium has announced the submission of a 510(k) for a new Hailie sensor designed specifically for use with Ellipta DPIs. In September 2021, the FDA cleared another version of the next generation… Read more . . .
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According to Optinose, the Phase 3 ReOpen1 trial of Xhance intranasal fluticasone propionate (OPN-375) in patients with chronic sinusitus met both of its primary endpoints, demonstrating statistically significant reduction in symptoms and in sinus inflammation… Read more . . .
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Tonix Pharmaceuticals has provided updates on two formulations of its intranasal potentiated oxytocin. The company acquired the license for one of the formulations, TNX-1900 for the treatment of migraine, from Trigemina in June 2020. According… Read more . . .
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