Regulatory
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According to Insmed, the FDA has lifted the clinical hold placed on Arikace liposomal amikacin for inhalation for the treatment of pseudomonas lung infections in cystic fibrosis patients in July 2011. A hold on Arikace… Read more . . .
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The FDA has issued a complete response letter to Alexza Pharmaceuticals regarding its New Drug Application (NDA) for Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or bipolar I disorder in… Read more . . .
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According to Meda, the FDA has approved Meda’s Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. Meda filed the NDA approximately one year ago, in April 2011. Meda CEO Anders… Read more . . .
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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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September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK