News
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According to Lupin, the FDA has approved its ANDA 0.5 mg/2 mL single dose ampules of budesonide inhalation suspension, a generic version of AstraZeneca’s Pulmicort Respules, for the treatment of asthma in children aged 12… Read more . . .
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According to Theravance Biopharma and Mylan, the FDA has approved the NDA for Yupelri revefenacin inhalation solution for the treatment of COPD. The NDA was submitted in November 2017, and the FDA accepted the application… Read more . . .
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InCarda Therapeutics has announced the completion of an oversubscribed $42 million Series B financing that will fund a Phase 2 study of InRhythm inhaled flecainide for the treatment of recent-onset paroxysmal atrial fibrillation (PAF). The… Read more . . .
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According to GlaxoSmithKline and Innoviva, the European Commission has approved a label change for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, extending its use to patients with moderate to severe COPD who do not achieve adequate… Read more . . .
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Mundipharma has announced that its license variation application to extend the use of the Flutiform fluticasone propionate/formoterol MDI to asthma patients aged 5 up to 12 years for whom an ICS/LABA combination is appropriate has… Read more . . .
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Insmed Incorporated has announced that its Chairman of the Board Donald Hayden, Jr is stepping down as chairman and will be replaced by Insmed President and CEO Will Lewis. Hayden, who served as chairman for… Read more . . .
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Eight years after being phased out at the end of 2011 due to its CFC propellant, Amphastar Pharmaceuticals’ Primatene Mist epinephrine MDI has been reinstated by the FDA as the only asthma inhaler approved for… Read more . . .
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Vectura and Hikma Pharmaceuticals have announced a deal for development and commercialization of generic versions of GSK’s Ellipta dry powder inhalers. Hikma will pay Vectura $15 million up front, $5 million at the start of… Read more . . .
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Intranasal drug developer Impel NeuroPharma has announced the appointment of former Allergan VP of External Science & Innovation Ellen A. Lubman as Chief Business Officer. Her previous experience also includes stints at Kadmon Pharmaceuticals and… Read more . . .
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AstraZeneca has announced that Covis Pharma will pay $350 million up front for the rights to market Alvesco ciclesonide MDI and the ciclesonide nasal spray Omnaris and nasal MDI Zetonna outside of the US. The… Read more . . .
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