Calls for papers
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The FDA published notices on February 16, 2016 announcing publication of draft guidances titled “Allergic Rhinitis: Developing Drug Products for Treatment” and “Nonallergic Rhinitis: Developing Drug Products for Treatment. The agency says that comments should… Read more . . .
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Lannett Company has received FDA approval for its sumatriptan nasal spray, a generic version of GSK’s Imitrex nasal spray. The company cites IMS statistics showing that US sales of sumatriptan nasal spray totaled $62 million… Read more . . .
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The FDA has accepted Mylan’s abbreviated new drug application for its generic fluticasone propionate/salmeterol DPI and has set a GDUFA goal date of March 28, 2017, the company said. Mylan filed the ANDA for the… Read more . . .
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MannKind Corporation has announced the resignation of Alfred Mann as Executive Chairman and the appointment of Kent Kresa as Chairman of the Board, effective immediately. Mann will continue as a non-executive advisor, the company said.… Read more . . .
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Serendex Pharmaceuticals has announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved the company’s planned IMPALA Phase 2/3 clinical trial of Molgradex inhaled molgramostim for pulmonary alveolar proteinosis (PAP). According to the… Read more . . .
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Capsugel and Pulmatrix have announced an agreement for development of new inhaled therapies based on the spray drying and manufacturing expertise at Capsugel’s Bend Research subsidiary combined with Pulmatrix’s iSPERSE dry powder technology. Bend Research… Read more . . .
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Novel Labs Job Description: Performs laboratory activities including development and validation of chromatographic (HPLC, UPLC, GC) and other applicable analytical methods specific to Metered Dose Inhaler product. Responsibilities: • Conduct reverse engineering, pre-formulation and formulation… Read more . . .
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Submit workshop proposals by February 26, 2016 at http://www.rddonline.com/rdd/rdd.php?id=13&sid=6&sub=462 For speaker proposals, submit a 200-word summary by March 1, 2016 using the online submission form Read more . . .
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UK-based Ockham Biotech has announced that data from a Phase 2b study of its inhaled heparin for the treatment of COPD demonstrate significant improvement in lung function compared to placebo, with improvements maintained for 7… Read more . . .
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Mylan has announced that it will acquire Meda, which markets a number of OINDPs, including Dymista, Astelin, and Astepro nasal sprays; the Aerospan MDI; and the Novopulmon Novolizer and Formatris Novolizer DPIs. Meda had previously… Read more . . .
Upcoming Events
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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