Calls for papers
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The FDA’s October 2016 release of new bioequivalence recommendations for specific products includes draft BE guidances for umeclidinium bromide inhalation powder (Incruse Ellipta), triamcinolone acetonide nasal spray (Nasacort), and olopatadine hydrochloride nasal spray (Patanase). For… Read more . . .
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Drug delivery device design company Coalesce Product Development has announced the opening of a new 375 sq m drug delivery development center in Cambridge, UK as well as several management changes, including the appointment of… Read more . . .
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The FDA has accepted Sunovion’s NDA for SUN-101 glycopyrrolate delivered by the PARI eFlow nebulizer for the treatment of COPD, the company said. The agency has set a PDUFA date of May 29, 2017 for… Read more . . .
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Johnson & Johnson subsidiary Cilag GmbH International will pay a total of $330 million to AstraZeneca for rights to Rhinocort Aqua budesonide nasal spray outside of the US, AstraZeneca has announced. Cilag operates as part… Read more . . .
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Aradigm Corporation has partnered with Professors Daniela Traini and Paul Young of the University of Sydney’s Woolcock Institute of Medical Research to develop an aerosol nanoparticle technology to combat fungal and bacterial biofilms. The project… Read more . . .
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The Intelligent Control Inhaler from 3M Drug Delivery Systems has won the drug delivery devices category of the CPhI Pharma Awards. According to CPhI, the inhaler was recognized “for its approach to addressing patient adherence… Read more . . .
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French device company Biocorp has announced the launch of its Inspair sensor, which it says is “capable of converting any pressurized metered dose inhaler into a connected device.” According to the company, the sensor works… Read more . . .
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Chiesi Farmaceutici has submitted an MAA to the European Medicines Agency (EMA) for its extra-fine ICS/LABA/LAMA combination inhaler for the treatment of COPD. The submission is the first for a triple combination inhaler. In June… Read more . . .
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Health Canada has approved Adapt Pharma’s Narcan naloxone nasal spray for reversal of known or suspected opioid overdose. The approval comes three months after Health Canada announced that it would allow importation of Narcan nasal… Read more . . .
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OptiNose has appointed Tom Gibbs as Chief Commercial Officer to oversee the commercialization strategy for EDS-FLU (OPN-375) intranasal fluticasone, which is in Phase 3 development for the treatment of nasal congestion in patients with nasal… Read more . . .
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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
October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany