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
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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
Lovaltech gets go-ahead for MUCOBOOST Phase 1 trial of LVT-001 intranasal vaccine against COVID-19
French biotech Lovaltech announced that the Agence nationale de sécurité du médicament (ANSM) and the Comité de Protection des Personnes (CPP) have authorized the company's planned MUCOBOOST Phase 1 trial of LVT-001 nasal vaccine against COVID-19, and the trial is expected to start by the end of April 2025. The study, which is expected to enroll 36 adults aged 18-55, … [Read more...] about Lovaltech gets go-ahead for MUCOBOOST Phase 1 trial of LVT-001 intranasal vaccine against COVID-19
Orbia announces appointments in its MDI propellants business
Orbia Fluor & Energy Materials (formerly Koura) has announced the appointments of a new General Manager, Global Commercial Director, UK Operations Director, and Technical Manager for its Pharma Business Unit, which includes Zephex brand MDI propellants, including its HFA 152a LGWP propellant. All of the newly announced appointments took place in the second … [Read more...] about Orbia announces appointments in its MDI propellants business
Health Canada approves Hikma’s Kloxxado naloxone nasal spray, which will be marketed in Canada by Emergent BioSolutions
According to Emergent BioSolutions, Health Canada has approved Hikma Pharmaceuticals' Kloxxado naloxone nasal spray 8 mg for the treatment of opioid overdose. In January 2025, Emergent announced that it was acquiring US and Canadian rights to Kloxxado, which has been approved in the US since 2021. Emergent, which already markets Narcan naloxone nasal spray 4 mg in … [Read more...] about Health Canada approves Hikma’s Kloxxado naloxone nasal spray, which will be marketed in Canada by Emergent BioSolutions
Paratek to acquire Optinose
US-based Paratek Pharmaceuticals will acquire all outstanding shares of intranasal drug developer Optinose in a deal worth up to $330 million, the companies said. According to the announcement, both companies' boards have approved the deal, which could close by mid-2025. Paratek will pay $9 per share up front plus up to an additional $5 per share in milestone payments … [Read more...] about Paratek to acquire Optinose
Cyrano licenses Resyca’s soft mist technology for delivery of CYR-064 intranasal theophylline for the treatment of post-viral loss of smell
Cyrano Therapeutics has acquired an exclusive license to use Resyca’s soft mist nasal spray technology for delivery of CYR-064 intranasal theophylline for the treatment of post-viral hyposmia. According to the announcement, the Phase 2 FLAVOR study of CYR-064 that was initiated in 2023 has been using an Ursatec spray pump enhanced with the Resyca technology for … [Read more...] about Cyrano licenses Resyca’s soft mist technology for delivery of CYR-064 intranasal theophylline for the treatment of post-viral loss of smell
Chance Pharma announces funding to support Phase 3 trial of CXG87 budesonide / formoterol DPI
DPI developer Chance Pharmaceuticals announced the completion of a financing round with participation from Heda Health Fund and Qihang Venture Capital, with proceeds intended to support Phase 3 trials of CXG87 inhaled dry powder budesonide / formoterol as well as development of some additional DPI formulations. The company did not specify the amount raised. Chance … [Read more...] about Chance Pharma announces funding to support Phase 3 trial of CXG87 budesonide / formoterol DPI
Polyrizon announces development of intranasal naloxone and agreement to develop intranasal formulation of a psychedelic therapy
Israeli biotech Polyrizon announced that it is beginning preclinical development of an intranasal naloxone formulation based on the company's Trap and Target mucoadhesive technology. The company said that Fabio Sonvico of the University of Parma, who is a member of Polyrizon's scientific advisory board, will conduct the studies. Polyrizon CEO Tomer Izraeli … [Read more...] about Polyrizon announces development of intranasal naloxone and agreement to develop intranasal formulation of a psychedelic therapy
Armata announces $10 million loan from Innoviva to fund development of candidates including AP-PA02 inhaled phage therapy
Armata Pharmaceuticals announced details of an additional secured credit agreement with Innoviva Strategic Opportunities, the company's largest shareholder. Armata said that it will pay interest at a 14% annual rate on the $10 million loan which matures on March 12, 2026. According to the announcement, the funds will be used for continued development of candidates … [Read more...] about Armata announces $10 million loan from Innoviva to fund development of candidates including AP-PA02 inhaled phage therapy