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The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Mundipharma’s MAA for Nyxoid naloxone nasal spray for the reversal of opioid overdose. Currently, no intranasal naloxone formulations are approved for… Read more . . .
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding GSK’s MAA for its triple combination fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD in patients… Read more . . .
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The FDA has approved a supplemental NDA for AstraZeneca’s Symbicort budesonide/formoterol fumarate MDI extending its use to include the reduction of COPD exacerbations. The sNDA, which was approved on September 11, 2017, included supporting data… Read more . . .
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Insmed has closed a public offering of common stock that generated net proceeds of ~$377.7 million, the company said. The proceeds will be used in large part for continued development, regulatory submissions, and potential commercialization… Read more . . .
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Summit Biosciences has announced that it can now produce prescription nasal sprays for the the European market after receiving EU GMP certification from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its manufacturing facilities… Read more . . .
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Adherium has introduced the SmartTurbo Model 4 monitoring device for the Turbuhaler DPI. The new device includes design improvements for older patients including easier installation and removal of the inhaler and larger buttons. According to… Read more . . .
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AstraZeneca has announced positive top-line from the Phase 3 AMPLIFY study of the Duaklir aclidinium bromide/formoterol DPI in patients with moderate to very severe COPD. The study met its primary endpoints by demonstrating statistically significant… Read more . . .
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Pulmatrix has announced a licensing agreement with Vectura for US development of Pulmatrix’s PUR0200 dry powder tiotropium formulation for the treatment of COPD. Vectura will pay Pulmatrix a $1 million “technology access fee” on achievement… Read more . . .
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According to Pulmatrix, the Cystic Fibrosis Foundation Therapeutics (CFFT) will provide funds to support non-clinical development of PUR1900, an itraconazole DPI, for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in cystic fibrosis and asthma patients.… Read more . . .
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Now that the Phase 3 CONVERT study has met its primary endpoint of culture conversion with statistical and clinical significance by Month 6, Insmed said, the company plans to seek priority review and accelerated approval… Read more . . .
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