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
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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
Oragenics says no indication of toxicity for its NT-CoV2-1 intranasal vaccine candidate
Oragenics said that results from a toxicology study of its NT-CoV2-1 intranasal vaccine conducted in rabbits "confirm a safety and immunogenicity profile that further support its plan to submit regulatory filings required to progress to a Phase 1 clinical study." In June 2022, the company published data from preclinical studies of NT-CoV2-1 in mice and hamsters … [Read more...] about Oragenics says no indication of toxicity for its NT-CoV2-1 intranasal vaccine candidate
DDL 2022 looked to the future of OINDP development
In its return to the Edinburgh International Conference Centre after two years of online-only meetings, the Drug Delivery to the Lungs conference looked toward the future, focusing on scientific and technical innovations that will influence inhaled and nasal drug development for years to come. The meeting drew a record crowd, with approximately 130 virtual … [Read more...] about DDL 2022 looked to the future of OINDP development
Orgenesis and Kurve say preclinical study demonstrated that intranasal cell therapy reduced tumors by 50% in a mouse model of glioblastoma
Biotech Orgenesis and nasal delivery specialist Kurve Therapeutics have announced results from a preclinical study of an intranasal "cell-based oncolytic virus bearing product" in a mouse model of glioblastoma. Orgenesis says that it manufactured the product on behalf of "a premier cell therapy development company." According to the companies, delivery of the product … [Read more...] about Orgenesis and Kurve say preclinical study demonstrated that intranasal cell therapy reduced tumors by 50% in a mouse model of glioblastoma
Beckley Psytech initiates Phase 2a study of BPL-003 intranasal dry powder 5-MeO-DMT for treatment-resistant depression
According to Beckley Psytech, the company has initiated a Phase 2a study of its BPL-003 intranasal dry powder 5-MeO-DMT for the treatment of moderate-to-severe treatment-resistant depression. Beckley Psytech recently reported results from a Phase 1 study showing a dose proportional PK profile for BPL-003; that study also found that any consciousness-altering effects … [Read more...] about Beckley Psytech initiates Phase 2a study of BPL-003 intranasal dry powder 5-MeO-DMT for treatment-resistant depression
Aerami Therapeutics names Lisa Yañez as CEO
Aerami Therapeutics has announced that its current Chief Operating Officer Lisa Yañez will succeed Steve Thornton as CEO, effective January 1, 2023. Thornton will continue as a member of the Board of Directors. Prior to joining Aerami in June 2022, Yañez was VP of Global Strategic Marketing at Acceleron Pharma and previously held marketing positions at United … [Read more...] about Aerami Therapeutics names Lisa Yañez as CEO