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
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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
Inhalon publishes data from preclinical studies of its inhaled muco-trapping therapies in RSV and SARS-CoV-2 models
Inhalon Biopharma has announced the publication of two articles that present data from preclinical studies of the company's inhaled "muco-trapping" technologies. The first, published in the journal Advanced Science, describes a study of nebulized delivery of Inhalon's Mota-MT antibody to the lungs of nonatal lambs infected with RSV. The second article, published … [Read more...] about Inhalon publishes data from preclinical studies of its inhaled muco-trapping therapies in RSV and SARS-CoV-2 models
AstraZeneca initiates 2 Phase 3 trials investigating the effects of Breztri Aerosphere MDI on cardiopulmonary factors and outcomes in COPD patients
AstraZeneca today announced the initiation of the Phase 3 ATHLOS and THARROS trials evaluating the effects of Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI on cardiopulmonary parameters and outcomes (including death) in COPD patients. Breztri was approved by the FDA for the treatment of COPD in July 2020. In August 2023, the agency issued a … [Read more...] about AstraZeneca initiates 2 Phase 3 trials investigating the effects of Breztri Aerosphere MDI on cardiopulmonary factors and outcomes in COPD patients