August 2012
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Amphastar Pharmaceuticals subsidiary Armstrong Pharmaceuticals has received a complete response letter from the FDA in regard to its NDA for the Primatene Mist epinephrine inhaler, Amphastar has announced. The CRL said that the FDA would… Read more . . .
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Vectura and Mundipharma have signed an agreement for the development and commercialization of the VR2076 ICS/LABA/LAMA MDI, Vectura has announced. Skyepharma, which was acquired by Vectura earlier this year, had previously announced a development and… Read more . . .
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According to Cipla, its Sereflo fluticasone/salmeterol MDI, a generic version of Advair (Seretide), has been approved by the UK MHRA for the treatment of asthma, and the product will be launched by a partner in… Read more . . .
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Horizon Pharma has announced that Quinsair levofloxacin inhalation solution is now available in Canada for the treatment of P. aeruginosa lung infections in adult cystic fibrosis patients. Horizon acquired Quinsair when it acquired Raptor Pharmaceutical… Read more . . .
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Easyhaler maker Orion Corporation has announced that it plans to submit a marketing authorization application in the EU for its salmeterol/fluticasone DPI for the treatment of asthma and COPD in the first half of 2017.… Read more . . .
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Bespak WHAT YOU’LL DO You’ll work with our clients, using your experience in best practice Design For Manufacturing techniques – design experience with pMDI (metered dose inhaler valves) technology and working to FDA Design Controls… Read more . . .
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In advertisements appearing in British nursing, pharmaceutical, and medical journals.the Prescription Medicines Code of Practice Authority (PMCPA), the administrator of the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry,… Read more . . .
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Sunovion has acquired exclusive US marketing rights to three Novartis DPIs for the treatment of COPD, the company has announced. The company said that it plans to market the Utibron (indacaterol/glycopyrrolate) Neohaler, Seebri (glycopyrrolate) Neohaler,… Read more . . .
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Evoke Pharma says that it recently had a positive pre-NDA meeting with the FDA regarding clinical data to be included in its planned 505(b)(2) NDA for Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis… Read more . . .
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GlaxoSmithKline and Innoviva have announced the initiation of a Phase 3 study of a fluticasone furoate/umeclidinium/vilanterol DPI compared to Relvar/Breo Ellipta for the treatment of asthma. GSK recently filed regulatory submissions for the FF/UMEC/VI DPI… Read more . . .
Featured event:
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5th Annual Inhaled & Nasal Biologics | DNA Forum
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October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
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