August 2012
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Tiziana Life Sciences announced that it will dose a patient with moderate Alzheimer’s disease with intranasal foralumab under an expanded access IND. The company previously used the expanded access program to provide intranasal foralumab to… Read more . . .
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According to Verona Pharma, the FDA has approved the company’s NDA for Ohtuvayre (ensifentrine, RPL554), a PDE3/PDE4 inhibitor delivered via jet nebulizer, for the treatment of COPD. Verona submitted the NDA for ensifentrine in June… Read more . . .
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Savara has announced that the Phase 3 IMPALA-2 trial of molgramostim nebulized recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with autoimmune pulmonary alveolar proteinosis (aPAP) met its primary endpoint, achieving statistically significant change in percent… Read more . . .
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OBG subsidiary Ayrton Saunders announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a Type II variation to the 2014 marketing authorization for the Voke nicotine inhaler, which is approved for… Read more . . .
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MannKind Corporation announced that the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics met its primary endpoint, with 30% of participants using Afrezza achieving… Read more . . .
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CDMO Ritedose Corporation announced that it has added blow-fill-seal (BFS) capacity to its manufacturing facility in Columbia, SC, USA that will allow it to manufacture an additional 180 million unit doses of opthalmic and respiratory… Read more . . .
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Proveris Scientific has announced the official launch of the Vereo NSx+SWC (spray, weigh, and collect) nasal spray system, which it recently exhibited at RDD 2024 and which it calls “a pivotal advancement in product development… Read more . . .
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Aerovate Therapeutics says that the Phase 2b portion of the Phase 2b/3 IMPAHCT trial of the company’s AV-101 inhaled dry powder imatinib in patients with pulmonary arterial hypertension (PAH) failed to meet its primary endpoint… Read more . . .
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Ethris announced that the Gates Foundation is providing $5 million, and Cipla is investing an additional €3 million, that will be used to prepare for Phase 2 development of Ethris’s ETH47 inhaled mRNA therapy. According… Read more . . .
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UK-based Enterprise Therapeutics, which is developing inhaled ENaC blockers for the treatment of cystic fibrosis and other respiratory conditions, has named former Insmed Executive VP of Development and Chief Medical Officer Renu Gupta as the… Read more . . .
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