Transpire Bio, which previously announced deals with Recipharm for development of four inhaled products, announced a new deal with INTO (Inhalation Together) for development of three additional inhaled products: TRB-5, TRB-6 and TRB-7. INTO is a partnership between DFE Pharma, Sterling, and Harro Höfliger that was formed earlier this year to provide early development … [Read more...] about Transpire Bio announces development deal with INTO and names new Chief Scientific Officer
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Odyssey Health creates subsidiary for development of intranasal drugs
Odyssey Health has announced the creation of a subsidiary called Odyssey Neuropharma that will develop intranasal drugs for the treatment of neurological disorders, including PRV-002 intranasal synthetic neurosteroid for the treatment of concussion. In addition to PRV-002, the company says that it intends to develop spray-dried dry powder nasal formulations for the … [Read more...] about Odyssey Health creates subsidiary for development of intranasal drugs
CoreRx adds particle engineering capabilities with Bend Bioscience deal
According to early stage CDMO Bend Bioscience, the company is now part of Florida-based CDMO CoreRx thanks to an equity investment by NovaQuest Private Equity, which acquired CoreRx in 2021. Bend Bioscience, which launched in 2021, will offer particle engineering and manufacturing services for a range of dosage forms, including dry powders for inhalation. Bend … [Read more...] about CoreRx adds particle engineering capabilities with Bend Bioscience deal
Positive Phase 1 results for Orexo’s OX640 intranasal epinephrine
According to Orexo, a Phase 1 trial of OX640 nasal epinephrine powder demonstrated that each of 4 formulations evaluated was safe and well tolerated and achieved epinephrine plasma levels comparable to autoinjected intramuscular epinephrine (EpiPen). Each of the intranasal formulations also produced concentration-dependent changes in blood pressure and heart rate. The … [Read more...] about Positive Phase 1 results for Orexo’s OX640 intranasal epinephrine
Blue Water to develop its intranasal S. pneumoniae vaccine for the prevention of pneumococcal pneumonia
Blue Water Vaccines said that it intends to develop its BWV-201 intranasal Streptococcus pneumoniae vaccine candidate for the prevention of non-invasive pneumococcal pneumonia. The company is already developing the live attenuated intranasal vaccine, which it licensed from St. Jude Children’s Research Hospital, for the prevention of acute otitis media in children. … [Read more...] about Blue Water to develop its intranasal S. pneumoniae vaccine for the prevention of pneumococcal pneumonia
Incannex announces completion of pre-IND meeting with FDA regarding IHL-216A inhaled CBD/isoflurane
Australian cannabinoid developer Incannex Healthcare said that its pre-IND meeting with the FDA regarding its IHL-216A inhaled CBD/isoflurane for the treatment of traumatic brain injury was "constructive." In June 2021, Incannex signed an agreement with inhalation CDMO Vectura for preclinical development services for IHL-216A. The company said at that time that … [Read more...] about Incannex announces completion of pre-IND meeting with FDA regarding IHL-216A inhaled CBD/isoflurane
Harm Reduction Therapeutics initiates rolling NDA submission for RiVive intranasal naloxone
Harm Reduction Therapeutics announced that it has made an initial filing for a rolling review of its NDA for RiVive naloxone nasal spray, an OTC product for the treatment of opioid overdose. In August 2022, the company announced that it had received Fast Track designation for RiVive (HRT001) and had signed a commercial supply agreement. The company said that it is … [Read more...] about Harm Reduction Therapeutics initiates rolling NDA submission for RiVive intranasal naloxone
Intranasal delivery of AstraZeneca’s COVID-19 vaccine fails to elicit sufficient immune response in Phase 1 trial
Disappointing data from a Phase 1 study of intranasal delivery of AstraZeneca's ChAdOx1 nCoV-19 vaccine against COVID-19 led researchers from the University of Oxford to conclude that there is a "need for further development of nasal spray vaccines," the university said. The researchers reported the results in The Lancet's eBioMedicine. Intranasal delivery of the … [Read more...] about Intranasal delivery of AstraZeneca’s COVID-19 vaccine fails to elicit sufficient immune response in Phase 1 trial
United Therapeutics announces the initiation of a second Phase 3 trial of Tyvaso in IPF patients
United Therapeutics has announced the initiation of the Phase 3 TETON 2 trial of Tyvaso treprostinil inhalation solution in patients with idiopathic pulmonary fibrosis (IPF). In December 2020, the company announced that the FDA had granted orphan drug designation to treprostinil for the treatment of IPF and had cleared an IND for the Phase 3 TETON program. The TETON 1 … [Read more...] about United Therapeutics announces the initiation of a second Phase 3 trial of Tyvaso in IPF patients
William Schachtner and Axel Perlwitz join Transpire Bio
Transpire Bio, a start-up inhaled drug developer based in Florida, has announced the appointment of two more OINDP experts, naming William Schachtner as Chief Technical Operations Officer and Axel Perlwitz as Chief Regulatory Affairs Officer. Like Transpire CEO Xian-Ming Zeng and Chief Medical Officer Mark Lepore, both Schachtner and Perlwitz previously held positions … [Read more...] about William Schachtner and Axel Perlwitz join Transpire Bio