The upcoming RDD Europe 2025 conference in Estoril, Portugal will mark the 20th anniversary of the first RDD Europe meeting, which took place in Paris in 2005. Co-organized by RDD Online and Aptar Pharma, the conference will take place May 6-9 and will once again include podium sessions, workshops, a poster exhibit, and a tabletop technology exhibition covering topics … [Read more...] about RDD Europe 2025 preview
News
HCmed names Chris Vernall as Executive VP of Business Development
Nebulizer maker HCmed has announced the appointment of Chris Vernall as its new Executive VP of Business Development. Vernall started his career as an inhalation scientist at Nanopharm and later returned to Nanopharm as Director of Business Development after a stint at Intertek. He then served in a similar role at Vectura before returning to Intertek in 2022 as … [Read more...] about HCmed names Chris Vernall as Executive VP of Business Development
Iconovo gets new European patent covering its ICOres inhaler platform
According to Iconovo, the European Patent Office has indicated that it will approve a patent application for an additional patent that will provide protection for Iconovo's ICOres reservoir-based dry powder inhaler platform until 2038. ICOres is already covered by patents in a number of countries, including Japan, China, and the US. Iconovo CEO Johan Wäborg … [Read more...] about Iconovo gets new European patent covering its ICOres inhaler platform
FDA accepts Liquidia’s resubmitted NDA for Yutrepia treprostinil DPI for the treatment of PAH and PH-ILD
Liquidia Corporation announced that FDA has accepted a resubmission of its 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) with a PDUFA goal date of May 24, 2025. The FDA tentatively approved Yutrepia for the treatment of PAH … [Read more...] about FDA accepts Liquidia’s resubmitted NDA for Yutrepia treprostinil DPI for the treatment of PAH and PH-ILD
FDA issues CRL to Milestone’s NDA for Cardamyst etripamil nasal spray for PSVT
Milestone Pharmaceuticals announced that it has received a complete response letter from the FDA in regard to the company's NDA for Cardamyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone first submitted the NDA in October 2023 and re-submitted the NDA in March 2024 after the FDA refused to accept the initial … [Read more...] about FDA issues CRL to Milestone’s NDA for Cardamyst etripamil nasal spray for PSVT
Chiesi announces plans for LGWP MDI production facility
Chiesi Group announced that it will spend €430 million to construct a new manufacturing facility on a site that it has acquired in Nerviano, Italy. The site will produce metered dose inhalers with low global warming potential (LGWP) propellants and will have development facilities for sterile biologics and dry powder inhalers. Plans for the 124,000 sq m site include … [Read more...] about Chiesi announces plans for LGWP MDI production facility
Savara completes BLA submission for Molbreevi molgramostim inhalation solution for the treatment of aPAP
Savara announced that it has completed its BLA submission for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company had announced the initiation of the rolling submission in December 2024. In June 2024, Savara announced that the Phase 3 IMPALA-2 study had met its primary endpoint. Molbreevi, … [Read more...] about Savara completes BLA submission for Molbreevi molgramostim inhalation solution for the treatment of aPAP
Aerogen opens India headquarters
Irish nebulization specialist Aerogen has announced the official opening of its India headquarters in New Delhi. According to Aerogen, the New Delhi office includes a library and recreation space in addition to offices for sales, marketing, and clinical personnel. The company said that it expects to expand staff at the location from 14 employees to 30 within 5 years … [Read more...] about Aerogen opens India headquarters
Vast’s ALX1 antibacterial inhalation solution gets QIDP designation
Vast Therapeutics announced that its ALX1 inhalation solution for the treatment of lung infections has received Qualified Infectious Disease Product designation from the FDA. The company describes ALX1 as a nitric oxide pro-drug, and the formulation is delivered via a PARI e-Flow nebulizer. Earlier this year, Vast announced that it had received a grant worth … [Read more...] about Vast’s ALX1 antibacterial inhalation solution gets QIDP designation
ReCode’s RCT2100 inhaled mRNA therapy for CF gets orphan drug designation from the FDA
According to ReCode Therapeutics, the FDA has granted orphan drug designation to the company's RCT2100 inhaled mRNA therapy for the treatment of cystic fibrosis in patients who do not benefit from CFTR modulators. In February 2024, ReCode announced the initiation of a Phase 1 trial of RCT2100 in healthy adults. The company says that a Phase 1b study is now recruiting … [Read more...] about ReCode’s RCT2100 inhaled mRNA therapy for CF gets orphan drug designation from the FDA