Alveolus Bio has received a 3-year Small Business Innovation Research (SBIR) FastTrack grant worth approximately $2.5 million from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) for development of an inhaled biotherapeutic for the treatment of COPD, the company said. The company's AB1000 inhaled live biotherapeutic … [Read more...] about Alveolus Bio gets $2.5 million SBIR FastTrack grant for development of inhaled live biotherapeutic
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FDA advisory committee recommends approval of Narcan naloxone nasal spray for OTC sales
The FDA's Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have voted unanimously in favor of over-the-counter use of Narcan naloxone nasal spray for the reversal of opioid overdose. In December 2022, the FDA accepted Emergent BioSolutions' sNDA for OTC sales of Narcan for priority review, with a PDUFA goal … [Read more...] about FDA advisory committee recommends approval of Narcan naloxone nasal spray for OTC sales
Savara announces management changes
Inhaled drug developer Savara has announced the appointments of former Strongbridge Biopharma executives Scott Wilhoit as Executive VP, Global Commercial, and Rob Lutz as Chief Operating Officer. The company also said that it had promoted Dave Lowrance from Chief Financial Officer to Chief Financial and Administrative Officer. Wilhoit, who has been a part-time … [Read more...] about Savara announces management changes
ENA Respiratory says interpretation of Phase 2a flu challenge study of INNA-051 antiviral nasal spray was “complicated” by pre-existing immunity
ENA Respiratory announced that "an unexpectedly large proportion of participants having pre-existing immunity to the challenge strain" resulted in difficulties interpreting data from a Phase 2a flu challenge study of its INNA-051 pegylated TLR2/6 agonist nasal spray. According to the company, dosing with "a substantial dose of H3N2 influenza A virus" failed to infect … [Read more...] about ENA Respiratory says interpretation of Phase 2a flu challenge study of INNA-051 antiviral nasal spray was “complicated” by pre-existing immunity
PureIMS names Frank Lambert Executive Director of Commercialization
PureIMS has appointed Frank Lambert as Executive Director Commercialization. Lambert, who was most recently Executive Director of Business Development for Early Development Services at ICON, will lead commercialization efforts for the company's Cyclops pre-filled disposable dry powder inhaler. PureIMS has Cyclops DPI formulations of levodopa, epinephrine, and … [Read more...] about PureIMS names Frank Lambert Executive Director of Commercialization
NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models
Researchers at North Carolina State University have published an article in Nature Materials describing preclinical development of an inhalation powder they are calling "SHIELD" (Spherical Hydrogel Inhalation for Enhanced Lung Defense) that has demonstrated the ability to block viral lung infections in mouse and non-human primate models. Studies found that the SHIELD … [Read more...] about NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models
Copley Scientific launches DUSA Shaker DTS 100i
Copley Scientific has announced the launch of its next generation DUSA Shaker, a semi-automated tool for rinsing dose uniformity sampling apparatus (DUSA) collection tubes. According to the company, the the new DTS 100i is a "comprehensively re-engineered and updated" version of the original DUSA Shaker that "provides full, fast, repeatable rinsing" and can be used … [Read more...] about Copley Scientific launches DUSA Shaker DTS 100i
Spexis gets funding for Phase 3 trials of ColiFin inhaled colistimethate sodium
Spexis has announced a deal with SPRIM Global Investments (SGI) for funding of up to half of Spexis' costs related to Phase 3 development of ColiFin nebulized colistimethate sodium for the treatment of P. aeruginosa lung infections in patients with cystic fibrosis. Spexis was formed in December 2021 through a merger of Polyphor, which was developing inhaled … [Read more...] about Spexis gets funding for Phase 3 trials of ColiFin inhaled colistimethate sodium
Tonix initiates Phase 2 trial of TNX-1900 intranasal oxytocin for the prevention of migraines
Tonix Pharmaceuticals has announced the initiation of the Phase 2 PREVENTION study of the company's TNX-1900 intranasal potentiated oxytocin for the prevention of migraine headaches. Tonix licensed TNX-1900 for the treatment of migraine from Trigemina in June 2020, and the company announced in November 2021 that the FDA had cleared an IND for a Phase 2 trial of … [Read more...] about Tonix initiates Phase 2 trial of TNX-1900 intranasal oxytocin for the prevention of migraines
Access to Advanced Health Institute gets award worth up to $9.9 million for development of intranasal RNA flu vaccine
Nonprofit biotech research institute Access to Advanced Health Institute (AAHI) said that it has received an award worth up to $9.9 million for a 40-month project aimed at development of liquid and dry powder versions of an intranasal influenza RNA vaccine candidate targeting the A(H5N1) and A(H7N9) avian influenza subtypes. The funding, which will support … [Read more...] about Access to Advanced Health Institute gets award worth up to $9.9 million for development of intranasal RNA flu vaccine