Gossamer Bio and Chiesi Farmaceutici have partnered to develop and commercialize Gossamer's seralutinib inhalation powder for the treatment of pulmonary hypertension, the companies announced. Chiesi, which will get 50% of US commercial profit and ex-US rights to seralutinib, will pay Gossamer $160 million for development reimbursement; up to $146 million in regulatory … [Read more...] about Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned
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Iconovo’s ICOres DPI gets Chinese patent
According to Iconovo, the Chinese Patent Office has said it will approve the company's application for a patent covering its ICOres reservoir-based dry powder inhaler platform that will provide protection until 2040. The ICOres platform has already received patent protection in the US, Europe, Sweden, India, and Japan, the company said. The dual chamber ICOres … [Read more...] about Iconovo’s ICOres DPI gets Chinese patent
MannKind’s clofazimine inhalation suspension gets Fast Track designation
MannKind Corporation announced that its MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections has been granted Fast Track designation by the FDA. MNKD-101 had already received orphan drug and qualified infectious disease product (QIDP) designations. The FDA recently cleared MannKind's IND for the Phase 3 … [Read more...] about MannKind’s clofazimine inhalation suspension gets Fast Track designation
Bespak and H&T Presspart announce partnership on LGWP propellant transition services
Device and component maker H&T Presspart and CDMO Bespak, which recently spun out from Recipharm, have announced that they will collaborate on projects related to low global warming potential (LGWP) propellants. According to the companies, "The collaboration leverages H&T Presspart’s expertise in inhalation product development, the company’s low GWP filling … [Read more...] about Bespak and H&T Presspart announce partnership on LGWP propellant transition services
ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus
ARS Pharmaceuticals announced has submitted its Day 180 response regarding the company's MAA for Neffy epinephrine nasal spray to the EMA's Committee for Medicinal Products for Human Use (CHMP) and expects an opinion on the MAA by mid-2024. The company said that it received Day 180 comments in late 2023 requesting results from a repeat dose study of Neffy under nasal … [Read more...] about ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus
MannKind announces plans for Phase 1 study of MNKD-201 nintedanib DPI
MannKind Corporation says that it will move ahead with a Phase 1 SAD/MAD study of MNKD-201 dry powder nintedanib for inhalation, which the company is developing for the treatment of fibrotic diseases of the lung, including idiopathic pulmonary fibrosis (IPF). The trial is expected to begin enrolling healthy volunteers in June 2024. MannKind CEO Michael Castagna … [Read more...] about MannKind announces plans for Phase 1 study of MNKD-201 nintedanib DPI
FDA clears IND for Phase 3 trial of MannKind’s MNKD-101 clofazamine inhalation suspension for the treatment of NTM
MannKind Corporation announced that the FDA has cleared the company's IND for the ICoN-1 Phase 3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). The company said that it expects to initiate the study in the US by mid-2024 and elsewhere by the end of the … [Read more...] about FDA clears IND for Phase 3 trial of MannKind’s MNKD-101 clofazamine inhalation suspension for the treatment of NTM
Nebu-Flow raises $5.9 million for continued development of its SAW nebulization technology
Nebu-Flow announced that it has closed a $5.9 million funding round led by venture capital firm SCVC that will support continued development of the company's surface acoustic wave (SAW) nebulization technology. In 2022, the University of Glasgow spinout announced that it had closed a £1.7 million funding round and received a £1 million grant from Innovate UK. … [Read more...] about Nebu-Flow raises $5.9 million for continued development of its SAW nebulization technology
FDA clears ENA Respiratory’s IND for a Phase 1b study of intranasal dry powder formulation of INNA-051 antiviral
According to ENA Respiratory, the FDA has cleared the company's IND for a Phase 1b study of a dry powder formulation of INNA-051, a TLR2/6 agonist, which the company has been developing as a pan-viral nasal spray. ENA said that it expects the study to begin in mid-2024. Development of the dry powder formulation is partially funded by the US Department of Defense … [Read more...] about FDA clears ENA Respiratory’s IND for a Phase 1b study of intranasal dry powder formulation of INNA-051 antiviral
FDA approves Amneal’s generic version of Narcan naloxone nasal spray
Amneal Pharmaceuticals announced that it has launched a generic over-the-counter naloxone nasal spray for the reversal of opioid overdose after its ANDA for the product was approved by the FDA. Amneal had announced the agency's acceptance of the ANDA in March 2023. The nasal spray is a generic version of Narcan, which was approved for OTC sales later in March … [Read more...] about FDA approves Amneal’s generic version of Narcan naloxone nasal spray