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
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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
Krystal Biotech initiates Phase 1 trial of inhaled KB707 gene therapy in patients with solid lung tumors
Krystal Biotech has announced the initiation of the KYANITE-1 Phase 1 trial of inhaled KB707 gene therapy in patients with advanced solid lung tumors. Inhaled KB707 received Fast Track designation from the FDA for this indication earlier this year. The open-label KYANITE-1 dose escalation and dose expansion study is expected to enroll 80 patients who will received … [Read more...] about Krystal Biotech initiates Phase 1 trial of inhaled KB707 gene therapy in patients with solid lung tumors
Kindeva Drug Delivery names Denis Johnson as Chief Operating Officer
Kindeva Drug Delivery has announced the appointment of Denis Johnson as Chief Operating Officer. Johnson was most recently Head of Global Manufacturing at Biogen and had previously served in executive roles at Catalent Pharma Solutions and Boston Scientific. The company noted that one of Johnson's focuses will be on Kindeva's efforts around transitioning MDIs to LGWP … [Read more...] about Kindeva Drug Delivery names Denis Johnson as Chief Operating Officer
Firebrick Pharma launches Nasodine povidone-iodine nasal spray in the US for “nasal hygiene”
Firebrick Pharma announced that it has launched Nasodine povidone-iodine nasal spray in the US via direct sales through a web site. The company said that it will not make any therapeutic claims so that the nasal spray will not require FDA approval. For now, Firebrick said, Nasodine will be marketed as a "nasal hygiene" product and will be available only on a US web … [Read more...] about Firebrick Pharma launches Nasodine povidone-iodine nasal spray in the US for “nasal hygiene”