Danish pharma company ALK says that it is paying ARS Pharmaceuticals $145 million up front and up to $320 million in potential milestone payments plus royalties for the rights to neffy intranasal adrenaline (epinephrine) everywhere except the US, Australia, New Zealand, Japan, and China. In addition to the marketing rights to neffy for the treatment of anaphylaxis, … [Read more...] about ALK acquires rights to ARS’s neffy adrenaline (epinephrine) nasal spray in much of the world
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CHI partners with Aptar Pharma for commercialization of the Quattrii DPI platform
Aptar Pharma will commercialize and promote Cambridge Healthcare Innovations' Quattrii blister-based dry powder inhaler platform, the companies said. According to the announcement, the platform is tunable and can be used with carrier or API-only formulations. CHI's web site says that the Quattrii DPI can be filled with up to 150 mg of powder and is capable of … [Read more...] about CHI partners with Aptar Pharma for commercialization of the Quattrii DPI platform
Bespak announces closure of its North Carolina facilities
Inhalation CDMO Bespak recently announced that it will close its site in Research Triangle Park, NC, USA by the end of the first quarter of 2025. Bespak spun out from Recipharm earlier this year with the stated purpose of focusing on the transition of MDIs to LGWP propellants. According to the company's announcement, it will be moving "selected product … [Read more...] about Bespak announces closure of its North Carolina facilities
OzUK announces new GLP pilot plant for development of MDIs with LGWP propellants
CRO OzUK has announced the availability of a new GLP pilot plant designed for pilot and feasibility studies of both solution and suspension MDIs filled with low global warming potential (LGWP) propellants. OzUK announced plans for the new facility in December 2023. According to the company, the new facility meets ATEX (Atmosphères Explosibles) standards for safety, … [Read more...] about OzUK announces new GLP pilot plant for development of MDIs with LGWP propellants
Tiziana says study of intranasal foralumab in addition to semaglutide demonstrated synergistic effects in mouse model of obesity
Tiziana Life Sciences announced that a preclinical study of its intranasal foralumab in combination with semaglutide (Ozempic / Wegovy) demonstrated synergistic effects in a mouse model of obesity, improving liver function and reducing inflammation more than semaglutide alone. The company says that it plans "to advance these promising preclinical findings into … [Read more...] about Tiziana says study of intranasal foralumab in addition to semaglutide demonstrated synergistic effects in mouse model of obesity
MannKind announces that results of Phase 1 trial of MNKD-201 nintedanib DPI support continued development
MannKind Corporation has announced that data from a recently completed Phase 1 study of MNKD-201 nintedanib DPI support continued development of the inhaler for the treatment of idiopathic pulmonary fibrosis (IPF). MannKind had announced plans for the Phase 1 SAD/MAD study earlier this year. The announcement includes highlights of safety results and does not present … [Read more...] about MannKind announces that results of Phase 1 trial of MNKD-201 nintedanib DPI support continued development
Kither Biotech announces initiation of Phase 1 trial of KIT2014 inhaled CFTR enhancer
Kither Biotech has announced the initiation of a Phase 1 trial of its KIT2014, an inhaled peptide that the company is developing as a CFTR enhancer for use as an add-on with CFTR modulators for the treatment of cystic fibrosis. The SAD/MAD study is expected to enroll 72 healthy volunteers and will evaluate as many as 6 dose levels of KIT2014 delivered via nebulizer … [Read more...] about Kither Biotech announces initiation of Phase 1 trial of KIT2014 inhaled CFTR enhancer
Satsuma resubmits its NDA for STS101 DHE nasal powder for migraine
Satsuma Pharmaceuticals announced that it has resubmitted its NDA for STS101 intranasal dry powder dihydroergotamine for the acute treatment of migraine with or without aura. The company initially submitted the NDA in March 2023 even though the Phase 3 SUMMIT trial of STS101 failed to meet its primary endpoints. In January 2024, the FDA issued a CRL to the … [Read more...] about Satsuma resubmits its NDA for STS101 DHE nasal powder for migraine
Polyrizon raises $4.2 million for continued development of its intranasal hydrogels
Intranasal hydrogel maker Polyrizon announced that it has closed a $4.2 million IPO, with a possibility of the total rising to $4.82 million if Aegis Capital exercises an option to purchase additional shares. Polyrizon said that funds from the IPO will be used for development of its hydrogel products for nasal drug delivery, called Capture and Contain (C&C), a … [Read more...] about Polyrizon raises $4.2 million for continued development of its intranasal hydrogels
Sensory Cloud says study of its alkaline hypertonic divalent salt aerosol for chronic cough demonstrated significant reduction in cough frequency
Sensory Cloud has announced the publication of an article in ERJ Open Research presenting data from a study of its SC001 intranasal alkaline hypertonic divalent salt in patients with refractory chronic cough (RCC). The company says it will now advance an orally inhaled formulation, SC0023 alkaline hypertonic divalent salt, into a Phase 2a trial. The study, which … [Read more...] about Sensory Cloud says study of its alkaline hypertonic divalent salt aerosol for chronic cough demonstrated significant reduction in cough frequency