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
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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”
Lonza’s Kimberly Shepard answers questions about spray drying biologics for inhalation
Kimberly Shepard is Director, Respiratory Delivery, at Lonza You presented a workshop at RDD 2023 subtitled, “From small molecules to all molecules” -- can all biotherapeutics really be spray dried for inhalation? Besides being a catchy title, “From small molecules to all molecules” captures the essence of what’s going on right now in the field of pharmaceutical … [Read more...] about Lonza’s Kimberly Shepard answers questions about spray drying biologics for inhalation
Orexo gets additional US patent covering OX640 epinephrine nasal powder
According to Orexo, the United States Patent and Trademark Office (USPTO) has granted US Patent No. 11,957,647 ("Pharmaceutical composition comprising adrenaline"), which covers Orexo's OX640 epinephrine nasal powder product. The USPTO previously issued US patent No. 11,737,980, which also provides protection for OX640, in August 2023. The FDA is currently … [Read more...] about Orexo gets additional US patent covering OX640 epinephrine nasal powder
Mundipharma and Vectura partner on LGWP reformulation of Flutiform MDI
Inhalation CDMO Vectura has partnered with Mundipharma to reformulate Flutiform fluticasone propionate / formoterol fumarate MDI using a lower global warming potential (LGWP) propellant, the companies announced. According to the announcement, the first step in the reformulation will be to identify which LGWP propellant will replace HFA-227 in the … [Read more...] about Mundipharma and Vectura partner on LGWP reformulation of Flutiform MDI
Adherium’s Hailie Smartinhaler monitor cleared for use with Airsupra and Breztri
According to inhaler monitor company Adherium, the FDA has cleared the Hailie Smartinhaler sensor for use with the Airsupra albuterol / budesonide MDI and with the Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI, both from AstraZeneca. The Hailie system is already approved for use with a number of different inhalers, including GSK's Ventolin, … [Read more...] about Adherium’s Hailie Smartinhaler monitor cleared for use with Airsupra and Breztri
Pulmocide says that Phase 2 trial demonstrated safety and tolerability of inhaled opelconazole
Pulmocide announced that the Phase 2 OPERA-S study of PC945 inhaled opelconazole in lung transplant patients demonstrated that the inhalation suspension was generally safe and well tolerated, with no subjects needing to discontinue or reduce medications due to interactions with immunosuppressant drugs. Pulmocide is developing PC945, which has been granted orphan drug, … [Read more...] about Pulmocide says that Phase 2 trial demonstrated safety and tolerability of inhaled opelconazole
Silo Pharma to acquire exclusive rights to SPC-14 and SPC-15 intranasal therapies from Columbia University
Silo Pharma announced that it will exercise an option for an exclusive worldwide license to develop SPC-14, an intranasal therapy for the treatment of Alzheimer’s disease, from Columbia University. Silo says that it expects the license agreement to be finalized by mid-2024 and that it plans to pursue the 505(b)(2) regulatory pathway. The company's pipeline also … [Read more...] about Silo Pharma to acquire exclusive rights to SPC-14 and SPC-15 intranasal therapies from Columbia University
Kexing Biopharm initiates Phase 3 trial of human interferon α1b inhalation solution
Kexing Biopharm announced that has initiated a Phase 3 trial of human Interferon α1b inhalation solution, which the company is developing for the treatment of children with pneumonia or bronchiolitis associated with respiratory syncytial virus. According to Kexing, a Phase 1 trial of the inhalation solution was completed in October 2023 and demonstrated low systemic … [Read more...] about Kexing Biopharm initiates Phase 3 trial of human interferon α1b inhalation solution