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
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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
MannKind presents data from Phase 4 trial of Afrezza inhaled insulin
MannKind Corporation announced that it recently presented initial data from a meal challenge that was part of the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics. Afrezza was approved by the FDA for the treatment of Type 1 and Type 2 diabetes in adults in 2014. The company said that it will … [Read more...] about MannKind presents data from Phase 4 trial of Afrezza inhaled insulin
Vast announces appointments in preparation for clinical development of ALX1 inhalation solution
Vast Therapeutics has announced the appointments of former Aradigm Senior Medical Director Paul Bruinenberg as Chief Medical Officer and Chris Polage as Medical Director in preparation for clinical development of its ALX1 inhalation solution. Bruinenberg was most recently Senior Medical Officer of the TB Alliance. In addition to his stint at Aradigm, Bruinenberg's … [Read more...] about Vast announces appointments in preparation for clinical development of ALX1 inhalation solution
Boehringer Ingelheim says it will limit out-of-pocket cost of its inhalers for some US patients
Boehringer Ingelheim said that "eligible patients" will pay no more than $35 per month for BI inhalers, including Atrovent HFA ipratropium MDI, Combivent Respimat ipratropium / albuterol SMI, Spiriva HandiHaler tiotropium DPI, Spiriva Respimat tiotropium SMI, Stiolto Respimat tiotropium / olodaterol SMI, and Striverdi Respimat olodaterol SMI. According to the company, … [Read more...] about Boehringer Ingelheim says it will limit out-of-pocket cost of its inhalers for some US patients
UWA researchers get A$500,000 grant for development of Spritz-OM probiotic nasal spray for ear infections
Researchers at the University of Western Australia have received a A$500,000 grant from the CUREator biotech incubator for development of the Spritz-OM probiotic nasal spray for the prevention of ear infections in children. The grant was one of 5 awarded recently as part of an effort to fund projects aimed at minimizing antimicrobial resistance. According to the … [Read more...] about UWA researchers get A$500,000 grant for development of Spritz-OM probiotic nasal spray for ear infections
Iconovo gets Innowide grant to support marketing activities in South Korea
Dry powder inhaler specialist Iconovo announced that the company has received a SEK 680,000 grant from the EU's Innowwide program that will fund a market study as part of Iconovo's plans to expand into the South Korean market. According to the company, the goal would initially be to attract South Korean customers for Iconovo's CDMO business and eventually licensing or … [Read more...] about Iconovo gets Innowide grant to support marketing activities in South Korea