Calls for papers
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Neurelis, which submitted an NDA for its Valtoco diazepam nasal spray in September 2018, has announced the appointments of a number of senior management personnel in anticipation of a launch. The appointments announced took place… Read more . . .
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Novus Therapeutics said that two Phase 1 trials of its OP0201 intranasal MDI, which is in development for otitis media, both met their primary endpoints. In one of the studies, healthy adults received either a… Read more . . .
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The FDA has announced the final approval of Teva’s ANDA for a generic naloxone hydrochloride nasal spray. According to the announcement, the agency tentatively approved the ANDA in June 2018. Opiant Pharmaceutical’s Narcan nasal spray… Read more . . .
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Akorn announced that the FDA has approved an ANDA for fluticasone propionate nasal spray submitted by Hi Tech Pharmacal, which was acquired by Akorn in 2014. The nasal spray is a generic of GSK’s Flonase,… Read more . . .
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What is dynamic powder testing and why is it valuable for DPI development? Read more . . .
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According to Hovione Technology, the company has acquired global development and commercialization rights to the Papillon multi-use dry powder inhaler from its inventor, Klaus-Dieter Beller. The blister-based DPI is reusable and formed from a single… Read more . . .
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Following Pulmatrix’s recent successful public offering, Pulmatrix and Cipla subsidiary Cipla Technologies (Cip Tec) have entered into a definitive agreement in which Cipla will acquire rights to the Pulmazole itraconazole DPI for the treatment of… Read more . . .
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Cipla Limited has announced the launch of its Niveoli extra-fine particle beclomethasone/formoterol fumarate MDI for the treatment of asthma and COPD in adults in India. Cipla India Business Head Nikhil Chopra commented, “Cipla is pleased… Read more . . .
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Insmed Incorporated said that the U.S. Patent and Trademark Office (USPTO) has issued US patent No. 10,251,900, titled “Methods for treating pulmonary non-tuberculous mycobacterial infections,” which is the 10th US patent covering the use of… Read more . . .
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According to Synspira Therapeutics, the company’s SNSP113 inhaled glycopolymer for the treatment of cystic fibrosis has received orphan drug desination from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). The FDA granted… Read more . . .
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