Israeli biotech BiomX has announced data from the first part of a Phase 1b/2a trial of the company's BX004 nebulized phage cocktail for the treatment of P. aeruginosa lung infections in cystic fibrosis patients demonstrating a reduction in P. aeruginosa burden. The first portion of the study, which is supported by the Cystic Fibrosis Foundation, enrolled 9 CF patients … [Read more...] about BiomX announces data from Phase 1b trial of its BX004 inhaled phage cocktail for the treatment of lung infections in CF patients
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Firebrick Pharma files Pediatric Investigation Plan for Nasodine povidone-iodine nasal spray
Firebrick Pharma announced that it has filed a Pediatric Investigation Plan (PIP) with the EMA's Pediatric committee for its Nasodine povidone-iodine nasal spray as the company plans to submit a marketing application for Nasodine by the end of 2023. In April 2022, Firebrick initiated a Phase 2 study of Nasodine for the treatment of COVID-19. A Phase 3 trial of … [Read more...] about Firebrick Pharma files Pediatric Investigation Plan for Nasodine povidone-iodine nasal spray
Optinose submits sNDA for Xhance fluticasone propionate nasal spray to treat chronic sinusitus
Optinose announced that it has submitted an sNDA for a label expansion of Xhance fluticasone propionate nasal spray (OPN-375) for the treatment of chronic sinusitis without nasal polyps. Xhance has been approved for the treatment of nasal polyps in the US since 2017. In June 2022, the company announced that the second of two Phase 3 trials of Xhance for the treatment … [Read more...] about Optinose submits sNDA for Xhance fluticasone propionate nasal spray to treat chronic sinusitus
Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT
Beckley Psytech said that the FDA has approved the company's IND for a Phase 2b study comparing 2 doses of BPL–003 intranasal dry powder synthetic 5-MeO-DMT (mebufotenin) in patients with treatment-resistant depression. According to Beckley Psytech, the proposed Phase 2b study, which is expected to be initiated in the first half of this year, is the first ever … [Read more...] about Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT
AAHI gets $3 million for development of antiviral nasal spray
The non-profit Access to Advanced Health Institute (formerly the Infectious Disease Research Institute) said that it has received an award of up to $3 million for development of a prototype antiviral nasal spray from the US Department of Defense (D0D). The news comes soon after AAHI announced that it had received an award of worth up to $9.9 million for development of … [Read more...] about AAHI gets $3 million for development of antiviral nasal spray
Codagenix raises $25 million for development of CodaVax-RSV intranasal vaccine against RSV
Codagenix said that it has completed a $25 million Series B extension financing, with funds primarily going to support development of its CodaVax-RSV intranasal live attenuated vaccine against respiratory syncytial virus. The FDA recently granted Fast Track designation to CodaVax-RSV. Investors in this funding round included the Serum Institute of India, Euclidean … [Read more...] about Codagenix raises $25 million for development of CodaVax-RSV intranasal vaccine against RSV
Alveolus Bio gets $2.5 million SBIR FastTrack grant for development of inhaled live biotherapeutic
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
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