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Regulatory

Pharmaxis gets marketing authorization for bronchitol in Europe

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 regarding approval of the drug after several prior negative opinions. The company will officially launch the product in Europe at … [Read more...] about Pharmaxis gets marketing authorization for bronchitol in Europe

Novartis expected to file NDAs for QVA149 and NVA237 in 2014

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 early in 2014 and an application for QVA149 by the end of that year. Novartis licensed NVA 237 from Sosei and Vectura. Both Sosei and … [Read more...] about Novartis expected to file NDAs for QVA149 and NVA237 in 2014

CHMP issues positive opinion on flutiform

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 to CHMP after the concerned member states failed to reach consensus on the application. According to SkyePharma, the company … [Read more...] about CHMP issues positive opinion on flutiform

MAP gets new patent for Levadex, schedules meeting with FDA

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 President and CEO Timothy S. Nelson said, "We are pleased that the FDA has scheduled a meeting with us to discuss the issues contained in the … [Read more...] about MAP gets new patent for Levadex, schedules meeting with FDA

British Pharmacopoeial Commission requests comment on changes to inhaled product monographs

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 that manufacturers of MDIs, DPIs, and nebulizer solutions submit comments along with any relevant data. The draft document … [Read more...] about British Pharmacopoeial Commission requests comment on changes to inhaled product monographs

European rights to aclidinium bromide to Menarini, review period extended by the FDA

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 and the Nordic countries, plus several additional countries, including Russia and Turkey. Almirall CEO Eduardo Sanchiz explained, … [Read more...] about European rights to aclidinium bromide to Menarini, review period extended by the FDA

MAP gets complete response letter for Levadex inhaled dihydroergotamine

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 to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. … [Read more...] about MAP gets complete response letter for Levadex inhaled dihydroergotamine

FDA approves QNASL HFA nasal aerosol

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 company plans to launch the product by the end of April 2012. QNASL is delivered by a pressurized nasal delivery device that includes a dose counter. Teva … [Read more...] about FDA approves QNASL HFA nasal aerosol

Astepro nasal spray approved in Europe

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 in individual countries in anticipation of a 2013 launch. Earlier this year, Meda filed suit against Apotex and Perrigo in the US … [Read more...] about Astepro nasal spray approved in Europe

Aradigm gets FDA clearance for Phase 3 trial of Pulmaquin

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 trials with 250 patients each. The company announced plans for the trials in December, 2011. Aradigm President … [Read more...] about Aradigm gets FDA clearance for Phase 3 trial of Pulmaquin

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