Jobs
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The US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) has awarded a grant worth up to $63 million to Emergent BioSolutions for development of a single-use stabilized isoamyl nitrite… Read more . . .
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GlaxoSmithKline announced that its NDA for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol for the treatment of COPD has been approved by the FDA. GSK said that Trelegy Ellipta should be available to patients in the US “shortly.”… Read more . . .
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The FDA has approved Optinose’s Xhance fluticasone propionate nasal spray (formerly OPN-375) for the treatment of nasal polyps, the company said. The product, which is based on the company’s exhalation delivery technology, should be available… Read more . . .
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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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The Inhaled & Nasal Biologics | DNA Forum
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September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany