Satsuma Pharmaceuticals said that the FDA has accepted the company's 505(b)(2) NDA for STS101 nasal powder dihydroergotamine for the treatment of migraine, and Satsuma expects the agency to set a PDUFA goal date in January 2024. Satsuma recently agreed to be reacquired by Shin Nippon Biomedical Laboratories (SNBL). According to Satsuma, data from the Phase 3 SUMMIT … [Read more...] about FDA accepts Satsuma’s NDA for STS101 intranasal dry powder DHE for the treatment of migraine
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CounterAct announces completion of human factors / usability study
CounterAct has announced results from a human factors / usability study of its nasal spray cap device that included a simulated rescue in an opioid overdose scenario. The CounterAct device, which is designed to snap onto a prescription pill bottle, contains a single dose of naloxone. According to the company, the average time required for participants in the study to … [Read more...] about CounterAct announces completion of human factors / usability study
RDD Europe 2023 highlighted sustainability, nasal drug delivery, and biologics
At RDD Europe 2023, which took place May 2-5 in Antibes, France, Richard Dalby noted in his opening remarks that approximately 420 inhaled and nasal drug delivery experts from 28 countries were attending the conference in person with another 20 or so delegates attending virtually. Noting that 2023 was the first in-person version of RDD Europe since 2019, he welcomed … [Read more...] about RDD Europe 2023 highlighted sustainability, nasal drug delivery, and biologics
Experic adds spray drying services
CDMO Experic announced that it is adding a pilot scale spray dryer spray at its facility in Cranbury, NJ, USA, extending the company's DPI formulation development capabilities. According to Experic, installation and validation of the new spray dryer are expected to be complete by July 2023. The company said that the spray drying services will complement its … [Read more...] about Experic adds spray drying services
PARI acquires equine nebulizer maker Nortev
Nebulizer manufacturer PARI announced that it has acquired equine nebulizer maker Nortev in a deal that the company suggested "opens attractive synergy potential." Nortev will continue to operate independently, the company said. According to PARI, Nortev also sells nebulizers for small pets in addition to its Flexineb device for horses, which is sold in more than 30 … [Read more...] about PARI acquires equine nebulizer maker Nortev
PADAC votes in favor of approval of ARS Pharmaceuticals’ Neffy intranasal epinephrine
The FDA's Pulmonary-Allergy Drug Advisory Committee (PADAC) voted at its May 11, 2023 meeting in support of approval of ARS Pharmaceuticals' Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, the company announced. Committee members voted 16-6 that the data supported a favorable risk/benefit assessment for use in adults and … [Read more...] about PADAC votes in favor of approval of ARS Pharmaceuticals’ Neffy intranasal epinephrine
SoftOx Solutions outsources development of SIS inhalation solution to the University of Copenhagen
SoftOx Solutions has announced a restructuring plan that includes shutting down its own GMP facility, laying off employees, and outsourcing further development of its SoftOx inhalation solution (SIS) to the University of Copenhagen. The company said that it would retain ownership of the IP and the commercial rights. In May 2022, SoftOx announced Phase 1 results … [Read more...] about SoftOx Solutions outsources development of SIS inhalation solution to the University of Copenhagen
Lumen Bioscience to develop antiviral intranasal powder for US Department of Defense
Lumen Bioscience said that it has received a contract worth $8.8 million from the Defense Innovation Unit (DIU) of the US Department of Defense for development of "a prototype broad-spectrum, fast-acting intranasal powder for treatment and prevention of known and emerging viral respiratory infections." The funding is part of "Project Panacea," run by DIU and the Joint … [Read more...] about Lumen Bioscience to develop antiviral intranasal powder for US Department of Defense
Codagenix initiates pediatric Phase 1 trial of CodaVax-RSV intranasal vaccine for the prevention of RSV
Codagenix announced that it has initiated a Phase 1 study of its CodaVax-RSV live-attenuated intranasal vaccine candidate in children aged 6 months to 5 years, with the study expected to enroll 18 children aged 2 to 5 years and 33 children aged less than 2 years. The FDA cleared an IND for the study in mid-2022. A previous Phase 1 study evaluated the nasal spray in … [Read more...] about Codagenix initiates pediatric Phase 1 trial of CodaVax-RSV intranasal vaccine for the prevention of RSV
Nanoform announces completion of successful GMP inspection
Nanoparticle technology specialist Nanoform Finland has announced the completion of a successful GMP inspection of its API manufacturing facility by the Finnish Medicines Agency (FIMEA). The company said that the agency issued no critical or major observations following the March 28, 2023 inspection, and the company's license was renewed. An independent GMP auditor … [Read more...] about Nanoform announces completion of successful GMP inspection