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 an insulin pump. Over the course of the 17-week study, one group will continue their usual insulin delivery method, and another group will use … [Read more...] about MannKind initiates Phase 4 INHALE-3 trial of Afrezza inhaled insulin
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Phase 2a study of Pieris and AstraZeneca’s elarekibep DPI discontinued
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 that it has been informed by AstraZeneca that pathology results from a 13-week toxicology study of inhaled dry powder … [Read more...] about Phase 2a study of Pieris and AstraZeneca’s elarekibep DPI discontinued
Vistagen reports results of Phase 1 study of itruvone (PH10) nasal spray
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 company had announced the initiation of the study to evaluate a new formulation of PH10 in January 2023. PH10 for the treatment of major … [Read more...] about Vistagen reports results of Phase 1 study of itruvone (PH10) nasal spray
FDA approves Lupin’s generic of Spiriva HandiHaler tiotropium bromide DPI
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, the DPI was approved in August 2022. According to Lupin, the company manufactures the product at its site in Pithampur, … [Read more...] about FDA approves Lupin’s generic of Spiriva HandiHaler tiotropium bromide DPI
FDA extends the PDUFA target date for review of ARS’s NDA for Neffy intranasal epinephrine
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 NDA for review in October 2022 and at that time, ARS said that the PDUFA date had been set for "mid-2023." The company says that the new PDUFA date … [Read more...] about FDA extends the PDUFA target date for review of ARS’s NDA for Neffy intranasal epinephrine
Padagis announces submission of ANDA for generic of Kloxxado naloxone nasal spray
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 to a 4 mg dose for Narcan nasal spray, was approved by the FDA in April 2021. Padagis launched a generic version of Narcan in the US in June … [Read more...] about Padagis announces submission of ANDA for generic of Kloxxado naloxone nasal spray
Resyca announces new Chief Technical Officer, licensing deal with Thaerapy
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 from Wilbur de Kruijf, who is leaving to serve as CEO of a start-up inhaled drug developer called Thaerapy. Resyca also announced that … [Read more...] about Resyca announces new Chief Technical Officer, licensing deal with Thaerapy
Tiziana announces the promotion of Matthew Davis to Chief Operating Officer
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 in addition to his role as COO. His previous experience includes roles at Endo, Lupin, and URL Pharma. According to the company, … [Read more...] about Tiziana announces the promotion of Matthew Davis to Chief Operating Officer
NMPA approves China Medical System’s NDA for diazepam nasal spray for the treatment of seizures
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 when the seizures are different for the patient's usual pattern of seizures. In the US, the diazepam nasal spray, which is marketed as … [Read more...] about NMPA approves China Medical System’s NDA for diazepam nasal spray for the treatment of seizures
Acadia Pharmaceuticals to develop intranasal carbetocin for the treatment of hyperphagia in PWS
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 in June 2022. Levo had licensed the intranasal carbetocin from Ferring Pharmaceuticals in 2017 and initiated Phase 3 … [Read more...] about Acadia Pharmaceuticals to develop intranasal carbetocin for the treatment of hyperphagia in PWS