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News

Acorda Therapeutics announces new supply agreement with Catalent for manufacture of Inbrija inhaled dry powder levodopa

Acorda Therapeutics announced that it has signed a new supply agreement with Catalent that reduces the amount of product that the company is required to buy annually from $18 million to $8.5 million for 2023 and $15.5 million for 2024. From 2025 on, the announcement says, Acorda will pay a fixed amount per capsule "based on the amount of Inbrija needed in the US and … [Read more...] about Acorda Therapeutics announces new supply agreement with Catalent for manufacture of Inbrija inhaled dry powder levodopa

BiondVax reports positive preclinical results for its NanoAb inhaled nanosized antibodies against COVID-19

BiondVax Pharmaceuticals announced that 6 days post infection, hamsters treated with the company's NanoAb inhaled nanosized antibodies had levels of SARS-COV-2 in their lungs reduced to levels 30 times lower than hamsters that got an inhaled placebo. BiondVax licensed the NanoAb technology from the Max Planck Institute in March 2022 and announced development plans for … [Read more...] about BiondVax reports positive preclinical results for its NanoAb inhaled nanosized antibodies against COVID-19

James Noble named Pneumagen Chairman of the Board

Inhaled antiviral developer Pneumagen has announced the appointment of Adaptimmune Therapeutics founder James Noble as non-executive Chairman of the company's board of directors. Noble also co-founded Immunocore and serves as Chairman of Sutura Therapeutics, Celleron, and Orexo. In August 2022, Pneumagen initiated a Phase 2 challenge study of its Neumifil … [Read more...] about James Noble named Pneumagen Chairman of the Board

Pulmatrix reports Phase 1 results for PUR3100 inhaled dry powder DHE

Pulmatrix has announced that a Phase 1 PK trial of its PUR3100 dihydroergotamine (DHE) DPI in healthy volunteers demonstrated that all 3 doses tested produced peak exposures in the desired range with a Tmax of 5 minutes post-dose. Subjects receiving PUR3100 also experienced less nausea than those getting IV DHE. Pulmatrix, which is developing PUR3100 for the treatment … [Read more...] about Pulmatrix reports Phase 1 results for PUR3100 inhaled dry powder DHE

Copley Scientific names new Managing Director and Head of Business Development

Copley Scientific has announced the appointments of Jamie Clayton as Managing Director and Matthew Fenn as Head of Business Development. Clayton joined powder characterization specialist Freeman Technology in 2008 and then served as Freeman's Operations Director beginning in 2011. Fenn has extensive experience in inhaled drug delivery and was most recently Senior … [Read more...] about Copley Scientific names new Managing Director and Head of Business Development

Cipla invests €15 million in inhaled mRNA developer Ethris

Cipla has announced a €15 million equity investment in inhaled mRNA developer Ethris. In February 2022, Ethris announced that it had closed a $26.3 million Series B financing round with proceeds going to support its ETH47 nebulized antiviral and ETH42 inhaled therapy for the treatment of primary ciliary dyskinesia. The company is also developing an inhaled mRNA … [Read more...] about Cipla invests €15 million in inhaled mRNA developer Ethris

FDA approves Polarean’s inhaled hyperpolarized contrast agent for lung ventilation imaging

According to Polarean Imaging, the FDA has approved the company's NDA for its Xenoview inhaled xenon-129 gas blend, a hyperpolarized contrast agent for MRI imaging of lung ventilation. Xenoview is approved for use in patients aged 12 and over. The agency also cleared two Polarean 510(k)s, one for a chest coil "intended to be worn by a patient who inhales … [Read more...] about FDA approves Polarean’s inhaled hyperpolarized contrast agent for lung ventilation imaging

FDA accepts Harm Reduction’s NDA for RiVive intranasal naloxone and grants Priority Review designation

According to Harm Reduction Therapeutics, the FDA has accepted the company's NDA for its RiVive naloxone nasal spray for the reversal of opioid overdose and granted the NDA Priority Review designation. Harm Reduction had announced the initiation of a rolling NDA submission for RiVive in October 2022. The company says that the FDA has set April 28, 2023 as the goal … [Read more...] about FDA accepts Harm Reduction’s NDA for RiVive intranasal naloxone and grants Priority Review designation

Researchers at the Centenary Institute and the University of Sydney get grant of almost AU$1 million for development of intranasal vaccine against COVID-19

According to the Centenary Institute, the New South Wales COVID-19 Vaccine Acceleration Research Grants Program has awarded a grant worth AU$995,867 to researchers at the Centenary Institute and the University of Sydney to support development of an intranasal vaccine against COVID-19. Sydney-based Ab Initio Pharma, which was recently granted a license to manufacture … [Read more...] about Researchers at the Centenary Institute and the University of Sydney get grant of almost AU$1 million for development of intranasal vaccine against COVID-19

Armata announces completion of Phase 1b/2a trial of AP-PA02 inhaled phage therapy in CF patients

Armata Pharmaceuticals announced that it has completed the Phase 1b/2a SWARM-P.a. trial of its AP-PA02 inhaled phage cocktail in cystic fibrosis patients who have chronic P. aeruginosa lung infections. The SWARM-P.a. study was initiated in 2020 with support from the Cystic Fibrosis Foundation. In October 2021, the Cystic Fibrosis Foundation and Innoviva made equity … [Read more...] about Armata announces completion of Phase 1b/2a trial of AP-PA02 inhaled phage therapy in CF patients

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