August 2012
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GlaxoSmithKline and Innoviva announced that GSK has submitted a supplemental new drug application for the use of the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of asthma. The FDA initially approved Trelegy Ellipta for… Read more . . .
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Savara said that the FDA provided a written response after a Type C meeting regarding the company’s planned biologics license application (BLA) submission for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment… Read more . . .
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Upsher-Smith has announced the US launch of Tosymra sumatriptan nasal spray. The FDA approved Tosymra for the treatment of migraine with or without aura in January 2019, and Upsher-Smith acquired US rights to the nasal… Read more . . .
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AstraZeneca Canada has announced today that Health Canada has approved the use of Symbicort Turbuhaler budesonide/formoterol DPI as an anti-inflammatory reliever for the treatment of mild persistent asthma. According to the company, the expanded use was based on… Read more . . .
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Texas-based Pulmotect, which is developing an inhaled immune stimulant for the treatment of respiratory diseases, has announced the appointment of Colin Broom as CEO. Broom was most recently CEO of Nabriva Therapeutics and previously served… Read more . . .
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According to AstraZeneca, the FDA has issued a complete response letter to the company’s NDA for PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of COPD. AstraZeneca recently announced positive results from the Phase 3 ETHOS… Read more . . .
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Lannett said that it has signed a US distribution agreement for rights to Respirent Pharmaceuticals’ generic Advair Diskus. The agreement would begin after FDA approval and would continue for 10 years after distribution begins. Lannett… Read more . . .
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Novartis has announced that its Phase 3 PALLADIUM trial of QMF149 indacaterol acetate/mometasone furoate (IND/MF) delivered via the Breezhaler DPI in patients with uncontrolled asthma met its primary endpoint, demonstrating superior improvement in lung function… Read more . . .
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Particle engineering company Nanoform has announced that AstraZeneca is performing an evaluation of Nanoform’s Controlled Expansion of Supercritical Solutions (CESS) technology “across a range of AstraZeneca’s proprietary pharmaceutical products.” According to the Nanoform, its technology can… Read more . . .
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Noveome Biotherapeutics said that it has initiated a Phase 1 safety trial of its ST266 secretome delivered intranasally in patients with intraocular hypertension. The study will use a device from SipNose designed to deliver drugs… Read more . . .
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