Regulatory
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The European Commission has granted marketing authorization to Pharmaxis for its Bronchitol mannitol inhalation powder for the treatment of cystic fibrosis in patients 18 and over. In October 2011, the CHMP adopted a positive opinion… Read more . . .
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According to Sosei, Novartis and the FDA have agreed on Phase 3 trial design for QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide, which should put the company on track to file an application for NVA237… Read more . . .
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The EMA’s Committee for Medicinal Products for Human Use (“CHMP”) has issued a positive opinion on SkyePharma’s MAA for its flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma. The MAA had been referred… Read more . . .
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MAP Pharmaceuticals has announced that it has a meeting scheduled with the FDA during the second quarter of this year to discuss the complete response letter it received for its Levadex inhaled dihydroergotamine application. MAP… Read more . . .
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The British Pharmacopoeial Commission is requesting comment from OINDP manufacturers regarding proposed changes to its inhaled product monographs. The BP has posted a draft document authored by its Inhaled Products Working Party and has asked… Read more . . .
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Almirall has licensed European rights to aclidinium bromide, both as a monotherapy and in combination with formoterol to Italian pharmaceutical company Menarini. The agreement covers most of the EU except for the UK, the Netherlands… Read more . . .
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The FDA has issued a complete response letter to MAP Pharmaceuticals’ NDA for Levadex dihydroergotamine inhalation aerosol for the treatment of migraine headaches. According to MAP, “the FDA requested that the Company address issues relating… Read more . . .
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According to Teva, the FDA has approved its QNASL HFA beclomethasone dipropionate nasal aerosol for the treatment of seasonal and perennial allergic rhinitis in adults and children 12 years of age and older, and the… Read more . . .
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Meda has announced that its Astepro azelastine nasal spray for the treatment of allergic rhinitis has received registration approval in Europe through the centralized procedure and that it will now begin the national registration processes… Read more . . .
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The FDA has cleared Aradigm’s Investigational New Drug Application (IND) for a Phase 3 clinical trial of Pulmaquin dual release ciprofloxacin for inhalation in non-cystic fibrosis bronchiectasis. The Phase 3 program include two one-year placebo-controlled… Read more . . .
Upcoming Events
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October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland