LTR Pharma announced a development agreement with Strategic Drug Solutions, Inc. for development of a nasal spray for the treatment of esophageal motility disorders (difficulty in swallowing). The Australian company says that the product will be called Oroflow but did not provide any additional information. LTR is currently developing Spontan intranasal vardenafil for … [Read more...] about LTR Pharma announces agreement with SDS for development of nasal spray for difficulty in swallowing
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Intertek announces expansion of its Melbourn, UK lab to add space for inhaled biologics testing
Intertek has announced a 6,000 sq ft expansion of its facility in Melbourn, UK to add laboratory space for characterization of large molecules for inhalation. In 2019, the company acquired a facility that doubled its total lab space in Melbourn to 40,000 sq ft at that time; the new expansion brings the total area to 46,000 sq ft. The company, which sponsors an … [Read more...] about Intertek announces expansion of its Melbourn, UK lab to add space for inhaled biologics testing
Ethris gets €10 million EU4Health grant for studies of ETH47 inhaled/nasal antiviral
Vaccine developer Ethris, which recently received $5 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) for development of spray-dried RNA vaccines for nasal delivery, has announced that EU4Health has awarded the company a €10 million grant to support research on ETH47, an mRNA-based antiviral designed specifically for respiratory … [Read more...] about Ethris gets €10 million EU4Health grant for studies of ETH47 inhaled/nasal antiviral
AstraZeneca says two Phase 3 trials of Breztri Aerosphere MDI in uncontrolled asthma met their primary endpoints
According to AstraZeneca, the Phase 3 KALOS and LOGOS trials comparing Breztri (Trixeo) Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI to inhaled ICS/LABA in patients with uncontrolled asthma both met their primary endpoints. Breztri has been approved in the US for the treatment of COPD since July 2020 and is currently approved that indication in … [Read more...] about AstraZeneca says two Phase 3 trials of Breztri Aerosphere MDI in uncontrolled asthma met their primary endpoints
FDA approves Ritedose’s ANDA for formoterol fumarate inhalation solution
Ritedose Pharmaceuticals has announced that the FDA approved the transfer of an ANDA for formoterol fumarate inhalation solution to Ritedose in April 2025. The company says that it expects to start shipping formoterol fumarate inhalation solution by mid-2025. In the announcement, Ritedose notes that it purchased the ANDA in 2024 from another manufacturer. … [Read more...] about FDA approves Ritedose’s ANDA for formoterol fumarate inhalation solution
FDA approves Satsuma’s Atzumi intranasal dry powder DHE for the treatment of migraine
According to Satsuma Pharmaceuticals, the FDA has approved the company's NDA for Atzumi dihydroergotamine nasal powder (STS101) for the treatment of migraine in adults. Although the Phase 3 SUMMIT trial of STS101 failed to meet its primary endpoints, Satsuma submitted an NDA for the intranasal DHE in March 2023, and the FDA issued a CRL to that application in January … [Read more...] about FDA approves Satsuma’s Atzumi intranasal dry powder DHE for the treatment of migraine
Bespak announces completion of life cycle assessment for its BK357 MDI valve
Inhalation CDMO Bespak announced that it has completed an independently verified life cycle assessment to evaluate environmental impacts associated with materials and manufacturing of its BK357 metered dose inhaler valve. The company said that the assessment is part of its sustainability effort, which also has included the addition of manufacturing capability for MDIs … [Read more...] about Bespak announces completion of life cycle assessment for its BK357 MDI valve
Nocion Therapeutics appoints Matthew Frankel as Chief Medical Officer
Nocion Therapeutics, which is developing inhaled dry powder taplucainium (NOC-110, formerly NTX-1175) for the treatment of chronic cough, has announced the appointment of Matthew Frankel as Chief Medical Officer. Frankel was most recently Chief Medical Officer at Chemomab Therapeutics and previously served as VP, Clinical Development and Medical Affairs, Specialty … [Read more...] about Nocion Therapeutics appoints Matthew Frankel as Chief Medical Officer
Akita gets Flu Lab grant for study of Profi nasal spray
Akita Biosciences announced that a grant from Flu Lab will fund a pilot study of the company's Profi prophylactic nasal spray in healthcare workers. Akita launched Profi, an OTC gel-forming drug-free nasal spray, in 2023 and currently sells the product online. The 8-week study will enroll workers in New York City public hospitals and clinics and will explore the … [Read more...] about Akita gets Flu Lab grant for study of Profi nasal spray
Iconovo announces it will downsize and focus on commercialization of existing DPI platforms
Swedish DPI developer Iconovo has announced that it will lay off about 10 employees as it switches its focus to commercialization of its existing dry powder inhalation platforms, including the ICOres reservoir-based DPI, the ICOpre generic version of Ellipta, and the ICOone single use device in both inhaled and nasal versions. Instead of continuing to do all … [Read more...] about Iconovo announces it will downsize and focus on commercialization of existing DPI platforms