Calls for papers
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Dr. Reddy’s Laboratories have announced that the company has launched generic levalbuterol inhalation solution in the US as of September 23, 2014. The generic version of Sunovion’s Xopenex is available in 0.31 mg /3 mL,… Read more . . .
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NovaBiotics has announced that its Lynovex (NM001) cysteamine for the treatment of cystic fibrosis has been granted orphan drug designation by the FDA. NovaBiotics is developing both oral and dry powder inhalation formulations of the… Read more . . .
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According to Mylan, the company will initiate a Phase 3 clinical trial of its generic version of Advair/Seretide Diskus for the treatment of asthma in October 2014, with an expected completion in April 2015. Mylan… Read more . . .
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Almac subsidiary Galen Ltd will pay Medical Developments International (MVP) approximately A$650,000 (~US$587,000) up front for a license to market and distribute MVP’s Penthrox inhaled methoxyflurane in the UK and Ireland. The deal also includes… Read more . . .
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According to Kind Consumer, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the company’s Voke nicotine inhaler for general sale. The company said that the license is “for use to relieve and/or… Read more . . .
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In its most recent interim report, Verona Pharma says that it raised over £14 million pounds earlier this year which will allow it to continue development of its RPL554, an inhaled PDE3/PDE4 inhibitor, for the… Read more . . .
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Prosonix has announced that a consortium of inhaled medicine and respiratory disease researchers with funding from the Biomedical Catalyst “has confirmed the potential of its Multi-component Particle (MCP) Technology for creating novel inhaled, dual and… Read more . . .
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Boehringer Ingelheim presented data from the 5500-patient, 52-week Phase 3 TONADO studies of tiotropium/olodaterol Respimat for moderate-to-severe COPD at the 2014 ERS International Congress. BI filed an DA for tiotropium/olodaterol Respimat in August 2014. According… Read more . . .
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Mundipharma presented new data from a Phase 3 study of the Flutiform fluticasone/formoterol MDI for the treatment of asthma in children aged 5 to 11 at the European Respiratory Society (ERS) Annual Congress, the company… Read more . . .
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Recent product-specific pharmacopeial monographs intended to assist developers of inhaled generic drugs call for the use of test equipment not specified in the USP/Ph. Eur. chapters on orally inhaled products. In this Q&A, Copley Scientific… Read more . . .
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