News
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A Phase 3 trial of Liquidia Technologies’ LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) is underway, the company said. The study is expected to enroll a minimum of 100 PAH patients… Read more . . .
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Egalet Corporation has terminated a co-promotion agreement with Septodont, the company said, and is now partnered with Valeant’s OraPharma division for co-promotion of Sprix ketorolac tromethamine nasal spray to US dentists and oral surgeons. Sprix… Read more . . .
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Janssen Research & Development has published data from a Phase 2 study of its intranasal esketamine that demonstrate rapid improvement of symptoms in patients with treatment-resistant depression. The study was conducted from 2014-2015, and results… Read more . . .
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By Lei Zhang, PhD, Deputy Director, Office of Research and Standards The FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs (OGD), Office of Research and Standards, Division of Therapeutic Performance has made… Read more . . .
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Generic DPI device developer Merxin has announced that its MRX003 capsule based dry powder inhaler has received CE marking certification. The inhaler, which was launched in May 2017, is designed for generic tiotropium products submitted… Read more . . .
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Savara has submitted an investigational new drug application for Molgradex inhaled recombinant human GM-CSF for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) to the FDA, the company said. In May 2017, the company said… Read more . . .
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A citizen petition filed by Mylan on December 5, 2017 asks the FDA not to approve any ANDA for a generic version of Advair Diskus that relies on data from multiple-batch PK bioequivalence studies “unless,… Read more . . .
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The FDA said in a Drug Safety Communication that it has approved the removal of Boxed Warnings about asthma-related deaths from ICS/LABA combination inhalers. The inhalers affected by the change are Advair Diskus, Advair HFA,… Read more . . .
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According to Korea Biomedical Review, Korean pharmaceutical company Huons has licensed Zephirus busesonide/salmeterol, a dry powder formulation delivered using the Axahaler capsule-based inhaler, from Belgian pharmaceutical company Laboratoires SMB. Korea Biomedical Review reported that Huons… Read more . . .
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Iconovo AB announced that it has signed an agreement with Intas Pharmaceuticals for development and licensing of a DPI for the treatment of asthma and COPD, including the dry powder formulation and a device based… Read more . . .
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