Calls for papers
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MannKind Corporation has announced the initiation of the Phase 4 INHALE-3 study of its Afrezza DPI in type 1 diabetes patients. The trial is expected to enroll approximately 120 type 1 diabetes patients who currently use… Read more . . .
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According to Pieris Pharmaceuticals, AstraZeneca has stopped a Phase 2a trial of elarekibep (PRS-060/AZD1402), an inhaled IL-4 receptor alpha inhibitor that the companies were developing for the treatment of asthma. In the announcement, Pieris said… Read more . . .
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Vistagen said that a Phase 1 study of itruvone (PH10) nasal spray, which the company is developing for the treatment of major depressive disorder, found that itruvone was well tolerated with no serious adverse events. The… Read more . . .
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Lupin announced that the FDA has approved the company’s ANDA for its generic of Boehringer Ingelheim’s Spiriva HandiHaler tiotropium bromide inhalation powder. Health Canada approved the company’s tiotropium DPI earlier this year. In the UK,… Read more . . .
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According to ARS Pharmaceuticals, the FDA has extend the PDUFA target date for completion of its review of ARS’s NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions. The agency accepted the… Read more . . .
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Padagis announced two recent ANDA submissions, including an ANDA for a generic version of Hikma’s Kloxxado naloxone nasal spray for the reversal of opioid overdose. Kloxxado, which delivers an 8 mg dose of naloxone compared… Read more . . .
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Soft mist inhaler developer Resyca, a joint venture of Medspray Pharma and Recipharm, has announced the promotion of current Head of Development and Project Management Nicolas Buchmann to Chief Technical Officer. Buchman will take over… Read more . . .
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Intranasal foralumab developer Tiziana Life Sciences announced the promotion of its Chief Medical Officer Matthew Davis to Chief Operating Officer. Davis, who joined Tiziana in July 2022, will continue to serve as Chief Medical Officer… Read more . . .
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China Medical System Holdings announced that the National Medical Products Administration of China has approved the company’s NDA for diazepam nasal spray for the treatment of seizure clusters in epilepsy patients age 6 and older… Read more . . .
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Acadia Pharmaceuticals announced that it will develop ACP-101 (formerly LV-101) intranasal carbetocin for the treatment of excessive hunger in Prader-Willi syndrome (PWS). Acadia acquired the rights to the nasal spray when it acquired Levo Therapeutics… Read more . . .
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