RDD Europe 2025, which took place in Estoril, Portugal May 6-9, welcomed approximately 490 delegates and 70 exhibitors from around the world to a meeting that focused on overcoming complex problems in order to advance inhaled and nasal drug delivery in a way that is more sustainable, personalized, and accessible. Attendees also joined organizers RDD Online and Aptar … [Read more...] about RDD Europe 2025 introduced “Inhalation 5.0”
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FDA issues Refuse to File letter regarding Savara’s BLA for Molbreevi molgramostim inhalation solution for the treatment of aPAP
According to Savara, the FDA has issued an RTF letter in response to the company's BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), citing insufficient CMC data. Savara completed its rolling BLA submission for Molbreevi in March 2025. The company says that it expects to request a Type A meeting … [Read more...] about FDA issues Refuse to File letter regarding Savara’s BLA for Molbreevi molgramostim inhalation solution for the treatment of aPAP
FDA approves Liquidia’s Yutrepia treprostinil DPI for PAH and for PH-ILD
At the end of March 2025, the FDA accepted Liquidia Corporations's resubmitted NDA for Yutrepia dry powder treprostinil for inhalation for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). According to Liquidia, the agency has now approved Yutrepia for both indications. The FDA … [Read more...] about FDA approves Liquidia’s Yutrepia treprostinil DPI for PAH and for PH-ILD
Nuance says Phase 3 ENHANCE-CHINA trial of nebulized ensifentrine met its primary endpoint
Nuance Pharma has announced that the Phase 3 ENHANCE-CHINA study of nebulized ensifentrine in patients with COPD has met its primary endpoint. The company obtained the rights to ensifentrine, a PDE3/PDE4 inhibitor, in China, Macau, Taiwan, and Hong Kong from Verona Pharma in 2021 and announced the initiation of the ENHANCE-CHINA trial in April 2023. Nuance says … [Read more...] about Nuance says Phase 3 ENHANCE-CHINA trial of nebulized ensifentrine met its primary endpoint
FDA approves Ritedose’s generic albuterol sulfate inhalation solution, 0.5%
According to Ritedose Pharmaceuticals, the FDA has approved an ANDA for the company's generic albuterol sulfate inhalation solution, 0.5%. In April 2023, Ritedose announced that it had begun manufacturing 5 mg/ml albuterol sulfate inhalation solution ampules for sales directly to hospitals under the 503B compounding pharmacy process. The company already marketed … [Read more...] about FDA approves Ritedose’s generic albuterol sulfate inhalation solution, 0.5%
Lupin announces plans to develop MDIs using Honeywell’s Solstice Air HFO-1234ze
Lupin has announced a new partnership with Honeywell and said that it will use Honeywell's Solstice Air HFO-1234ze, a low global warming potential (LGWP) propellant, in Lupin metered dose inhalers. The announcement did not specify whether Lupin intends to transition existing MDIs to HFO-1234ze or whether it plans to develop new MDIs with the new propellant; however, … [Read more...] about Lupin announces plans to develop MDIs using Honeywell’s Solstice Air HFO-1234ze
Rein Therapeutics initiates Phase 2 trial of its LTI-03 caveolin-1-related peptide DPI in IPF patients
Rein Therapeutics (formerly Aileron Therapeutics) has announced the initiation of the Phase 2 RENEW trial of LTI-03, an inhaled dry powder caveolin-1 scaffolding domain peptide. The company had announced plans for the study in January 2025 and recently said that it had received two new patents covering LTI-03. The trial is expected to enroll up to 120 patients … [Read more...] about Rein Therapeutics initiates Phase 2 trial of its LTI-03 caveolin-1-related peptide DPI in IPF patients
UK MHRA approves AstraZeneca’s reformulated Trixeo (Breztri) Aerosphere MDI with HFO-1234ze as the propellant
AstraZeneca announced the that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the company's marketing application for a reformulated Trixeo (Breztri) Aerosphere budesonide / glycopyrronium / formoterol fumarate that uses Honeywell's Solstice Air HFO-1234ze as a propellant. The company says that it expects to launch the HFO-1234ze … [Read more...] about UK MHRA approves AstraZeneca’s reformulated Trixeo (Breztri) Aerosphere MDI with HFO-1234ze as the propellant
Aptar CSP expands capacity for clinical packaging of DPI capsules
Aptar CSP Technologies has announced an expansion of its cGMP manufacturing capacity for clinical packaging of dry powder inhalation capsules using the company's Activ-Blister technology. Aptar CSP cited growing demand for the technology for both oral dose and DPI capsules as the reason for launching the new site in New Jersey. According to the company, the site will … [Read more...] about Aptar CSP expands capacity for clinical packaging of DPI capsules
3P Innovation launches new filling system for generic Diskus and Ellipta DPI products
3P innovation has announced that it is now offering new filling technology in its custom-built DPI filling systems that is based on equipment originally patented by GSK for high-speed filling of Diskus dry powder inhalers. The company notes that its founder, Tom Bailey, led development of filling technology for the original Diskus filling system which later was used … [Read more...] about 3P Innovation launches new filling system for generic Diskus and Ellipta DPI products