August 2012
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According to Krystal Biotech, the FDA has granted orphan drug designation to the company’s KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin (AAT) deficiency. Krystal, which is also developing inhaled gene therapies for… Read more . . .
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Insmed announced that the Phase 3 ARISE study of Arikayce amikacin liposome inhalation suspension demonstrated the effectiveness of the QOL-B questionnaire for patient-reported outcomes. The ARISE study of Arikayce in patients with nontuberculous mycobacterial (NTM)… Read more . . .
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ENA Respiratory announced preparations for a Phase 2b study of its INNA-051 pegylated TLR2/6 agonist nasal spray for the prevention of respiratory viruses in people aged 65 and older will be supported by an additional $3.8… Read more . . .
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According to Orexo, the United States Patent and Trademark Office (USPTO) has issued the company US patent No. 11,737,980 (“Pharmaceutical composition for drug delivery”) which provides protection for OX640 epinephrine nasal powder. Orexo notes that… Read more . . .
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PureIMS has announced that it intends to initiate a dose-finding study of its Levodopa Cyclops DPI titled “A pilot open-label, randomized, crossover, comparative bioavailability study of levodopa administered via Levodopa Cyclops (test product) relative to… Read more . . .
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Immune Biosolutions has announced the publication of results from Phase 1 and 2 trials of the company’s IBIO123 inhaled antibody therapy in patients with COVID-19 in The Lancet Infectious Diseases. Immune Bio announced the initiation of… Read more . . .
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Propellant manufacturer Honeywell and CDMO Recipharm are partnering on development of MDIs formulated with Honeywell’s Solstice Air lower-GWP propellant, the companies said. Honeywell announced in October 2022 that it had started large scale manufacturing of… Read more . . .
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The FDA issued a warning letter to AstraZeneca dated August 4, 2023 that cites multiple “false or misleading claims and/or representations” about the efficacy of the company’s Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate… Read more . . .
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Lupin has launched its generic version of Spiriva HandiHaler tiotropium bromide DPI for the treatment of COPD in the US, the company said. The FDA approved Lupin’s ANDA for the tiotropium bromide inhaler in June… Read more . . .
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Trudhesa dihydroergotamine (DHE) nasal spray maker Impel Pharmaceuticals (formerly Impel Neuropharma) has filed a document with the US Securities and Exchange Commission stating that it “has concluded that there is substantial doubt about the Company’s… Read more . . .
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