Intravacc has announced that a Phase 1 study of Avacc 10 intranasal vaccine as a booster against SARS-CoV-2 induced a mucosal response in subjects who received the higher of two doses tested, and the vaccine was well tolerated. The company announced in November 2022 that it was initiating the Phase 1 study of Avacc 10. According to Intravacc, the study enrolled 36 … [Read more...] about Intravacc announces data from Phase 1 study of Avacc 10 intranasal SARS-CoV-2 vaccine as a booster
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Tonix gets Rare Pediatric Disease Designation for TNX-2900 intranasal potentiated oxytocin for PWS
According to Tonix Pharmaceuticals, the FDA has granted Rare Pediatric Disease Designation to TNX-2900 intranasal potentiated oxytocin for the treatment of Prader-Willi syndrome (PWS) in children and adolescents. Tonix licensed TNX-2900 from the French National Institute of Health and Medical Research (Inserm) in February 2021, and the FDA granted orphan drug … [Read more...] about Tonix gets Rare Pediatric Disease Designation for TNX-2900 intranasal potentiated oxytocin for PWS
Blue Lake announces preliminary data from Phase 1/2a trial of BLB201 intranasal RSV vaccine in young children
Blue Lake Biotechnology has announced initial results from a Phase 1/2a clinical trial of its BLB201 intranasal vaccine against severe respiratory syncytial virus disease in children aged 8 months to 59 months with or without prior RSV infection. The company has previously announced results from a Phase 1 trial BLB201 in adults aged 18-59 and 60-75. In 2022, the FDA … [Read more...] about Blue Lake announces preliminary data from Phase 1/2a trial of BLB201 intranasal RSV vaccine in young children
Inhalon reports data from Phase 1b trial of IN-006 inhaled regdanvimab
Inhalon Biopharma announced that a Phase 1b study that evaluated the company's IN-006 nebulized regdanvimab in healthy volunteers demonstrated successful delivery of the inhaled antibodies throughout the respiratory tract, achieving uniform distribution and significantly higher concentrations than for intravenous regdanvimab. The study was funded by the United States … [Read more...] about Inhalon reports data from Phase 1b trial of IN-006 inhaled regdanvimab
TFF says it will prioritize development of its tacrolimus DPI
TFF Pharmaceuticals says that it will prioritize development of TFF TAC inhaled dry powder tacrolimus for the prevention of lung transplant rejection after receiving positive data from an ongoing Phase 2 trial. The company will now de-prioritize development of TFF VORI inhaled dry powder voriconazole for the treatment of invasive pulmonary aspergillosis. According … [Read more...] about TFF says it will prioritize development of its tacrolimus DPI
RDD 2024 to cover the latest OINDP development trends
From May 5-9, RDD 2024 will welcome an international gathering of OINDP experts to the JW Marriott Starr Pass Resort and Spa in Tucson, AZ, which previously hosted RDD 2018. According to Richard Dalby of RDD Online, registration for the meeting so far has been strong, with a higher-than-usual contingent of delegates from outside of North America and Europe … [Read more...] about RDD 2024 to cover the latest OINDP development trends
AstraZeneca follows Boehringer Ingelheim in capping inhaler costs for some US patients
AstraZeneca has announced that it will "expand the savings programs for its entire US inhaled respiratory portfolio," capping costs at $35 per month for "eligible patients" as of June 1, 2024, while noting that "terms and conditions apply." Inhalers covered by the program include Airsupra albuterol / budesonide MDI, Bevespi Aerosphere glycopyrrolate / formoterol … [Read more...] about AstraZeneca follows Boehringer Ingelheim in capping inhaler costs for some US patients
Kindeva appoints Jenifer Riter as VP of Analytical Services
Kindeva Drug Delivery has named former West Pharmaceutical Services Senior Director, Business and Technical Operations, Jennifer Riter as VP of Analytical Services. Earlier this year, Kindeva announced the launch of its new analytical services business, which will offer medical device, container closure, and extractables and leachables testing. Riter worked in … [Read more...] about Kindeva appoints Jenifer Riter as VP of Analytical Services
FDA approves Optinose’s Xhance nasal spray for the treatment of chronic sinusitis without nasal polyps
According to Optinose, the FDA has approved the company's sNDA to extend use of Xhance fluticasone propionate nasal spray to include the treatment of chronic sinusitis without nasal polyps. Xhance was approved by the FDA for the treatment of nasal polyps in 2017. Optinose submitted the sNDA in February 2023. The FDA accepted the sNDA in May 2023 and set a PDUFA date … [Read more...] about FDA approves Optinose’s Xhance nasal spray for the treatment of chronic sinusitis without nasal polyps
Aptar Pharma to add nasal delivery device manufacturing capacity
Device manufacturer Aptar Pharma announced that it will expand its production facility in Congers, NY, USA, including a significant increase in its capacity for manufacturing the Unidose (UDS) nasal delivery system. The expansion includes new cleanroom manufacturing, with additional molds and assembly lines for the nasal devices expected to come online by the end of … [Read more...] about Aptar Pharma to add nasal delivery device manufacturing capacity