August 2012
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Insys Therapeutics, which recently filed for bankruptcy, said that the FDA has accepted its NDA for the company’s single unit dose naloxone nasal spray. In December 2018, Insys said that it planned to submit NDAs… Read more . . .
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Kurve Technology has announced that Seurat Therapeutics will use Kurve’s intranasal delivery technology for Seurat’s IGF-1 nasal aerosol for the treatment and prevention of migraines. Details of the development and collaboration agreement were not disclosed.… Read more . . .
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Liquidia Technologies has announced amendments to its 2012 collaboration agreement with GlaxoSmithKline that gave GSK the rights to develop inhaled dry powder formulations based on Liquidia’s PRINT particle manufacturing technology. Under the terms of the… Read more . . .
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Insmed has announced that it raised ~$25.6 million in net proceeds through the sale of additional shares after a public offering earlier this year netted approximately $235.5 million. The underwriters of that offering had a… Read more . . .
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Glenmark Pharmaceuticals has revealed that the FDA issued a complete response letter to the company’s NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray. The agency accepted the NDA for Ryaltris in August 2018 with a… Read more . . .
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According to Syqe Medical, the company has received regulatory approval from the Israeli Ministry of Health to launch its metered-dose cannabis inhaler in Israel for the treatment of pain. The inhaler, which was previously available only… Read more . . .
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The Japanese Ministry of Health, Labour and Welfare has approved AstraZeneca’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. Bevespi Aerosphere has been approved for the treatment of COPD in the US since… Read more . . .
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Boehringer Inhgelheim has opened a new €120 million Respimat manufacturing facility in Sant Cugat del Vallés, Spain, near Barcelona, the company said. The 17,000 sq m plant is expected to produce 25 million units per… Read more . . .
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Theravance Biopharma and Mylan have expanded their 2015 development and commercialization agreement for nebulized revefenacin (formerly TD-4208) to include China, Hong Kong, Macau, and Taiwan. The 2015 agreement included all markets except for China and… Read more . . .
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Upsher-Smith Laboratories has acquired the US rights to Tosymra sumatriptan nasal spray from Dr. Reddy’s Laboratories, the companies have announced. The FDA approved Dr. Reddy’s subsidiary Promius Pharma’s NDA for Tosymra in January 2019. The… Read more . . .
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5th Annual Inhaled & Nasal Biologics | DNA Forum
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