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
News
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
Chiesi initiates Phase 3 trial of HFA 152a version of its Trimbow MDI
Chiesi has announced the initiation of a Phase 3 safety study of CHF5993 beclometasone / formoterol / glycopyrronium HFA 152a MDI, an LGWP propellant version of Trimbow MDI, which uses HFA 134a as a propellant. In December 2019, Chiesi announced that it planned to bring an HFA 152a inhaler to market by the end of 2025. The Phase 3 trial will compare the HFA 152a … [Read more...] about Chiesi initiates Phase 3 trial of HFA 152a version of its Trimbow MDI
SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
The Cystic Fibrosis Foundation announced that it making an additional investment of up to $8.5 million to support a Phase 2 trial of SpliSense's nebulized SPL84 antisense oligonucleotide in patients with cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has received Orphan Drug designation from both the EMA and the FDA. According to SpliSense, the … [Read more...] about SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
ARS Pharmaceuticals said that it has submitted its response to the complete response letter it received from the FDA in September 2023 regarding the company's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis. The CRL included a request for a repeat dose nasal allergen challenge study of Neffy, which was completed … [Read more...] about ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
Lonza now offers spray drying of proteins for inhalation
Lonza has announced that its Center of Excellence for respiratory formulations in Bend, OR, US can now offer kilogram scale spray drying of proteins for inhalation. With the latest expansion, the company is now able to serve customers who need clinical and/or commercial manufacturing for protein DPI formulations. Lonza Director, Respiratory Delivery, Kimberly … [Read more...] about Lonza now offers spray drying of proteins for inhalation
Bespak spins out from Recipharm, will focus on LGWP transition
Bespak will go forward as a standalone CDMO after separating from former parent company Recipharm in order to focus on the transition to lower global warming potential (LGWP) propellants, the company announced. The new Bespak Group will be led by the former President of Recipharm's Advanced Delivery Systems Business Unit, Chris Hirst, as CEO, and former Teva CEO Kåre … [Read more...] about Bespak spins out from Recipharm, will focus on LGWP transition