ARS Pharmaceuticals has announced that its partners in China, Japan, and Australia have all submitted marketing applications for approval of neffy epinephrine nasal spray for the treatment of serious allergic reactions in their respective countries. ARS is partnered with Pediatrix Therapeutics in China; with Alfresa Pharma in Japan; and with CSL Seqirus in Australia … [Read more...] about ARS says regulatory submissions for neffy epinephrine nasal spray have been filed in China, Japan, and Australia
Regulatory
MannKind’s Afrezza insulin DPI approved in India for the treatment of diabetes
According to MannKind Corporation, the Indian Central Drugs Standard Control Organization (CDSCO) has approved a marketing application submitted by Cipla for Afrezza inhaled dry powder insulin for the treatment of diabetes in adults. Cipla acquired the rights to market Afrezza in India in a deal signed in 2018. Afrezza has been approved in the US since 2014 and … [Read more...] about MannKind’s Afrezza insulin DPI approved in India for the treatment of diabetes
MHRA grants Innovation Passport designation to Iliad’s BPZE1 intranasal pertussis vaccine
According to Iliad Biotechnologies, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) has granted Innovation Passport designation to Iliad's BPZE1 intranasal pertussis vaccine. BPZE1, which is in Phase 2 development, has previously received Fast Track designation from the FDA. The company notes that Phase 2b trials of BPZE1 in both adults and … [Read more...] about MHRA grants Innovation Passport designation to Iliad’s BPZE1 intranasal pertussis vaccine
FDA accepts Satsuma’s resubmitted NDA for STS101 intranasal dry powder DHE for the treatment of migraine
According to Satsuma Pharmaceuticals and its parent company Shin Nippon Biomedical Laboratories, the FDA has accepted the company's resubmitted NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine and has set a PDUFA date of April 30, 2025. Satsuma submitted the now-accepted NDA in October 2024. In March 2023, Satsuma submitted the original … [Read more...] about FDA accepts Satsuma’s resubmitted NDA for STS101 intranasal dry powder DHE for the treatment of migraine
NurExone’s ExoPTEN intranasal exosome therapy for spinal cord injuries get orphan designation from the EMA
NurExone Biologic announced that the EMA has granted orphan medicinal product designation to NurExone's ExoPTEN intranasal exosome therapy, which the company is developing for the treatment of spinal cord injury. In 2023, the FDA granted orphan drug designation to ExoPTEN, and the company held a pre-IND meeting with the agency in anticipation of beginning clinical … [Read more...] about NurExone’s ExoPTEN intranasal exosome therapy for spinal cord injuries get orphan designation from the EMA
AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
UK-based start-up AlveoGene announced that its AVG-002 nebulized gene therapy for neonatal surfactant protein B (SP-B) deficiency has received a rare pediatric disease designation from the FDA. The company says that it will advance AVG-002 into clinical development and could submit a marketing application as soon as 2028. According to Alveogene, studies in SP-B … [Read more...] about AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
Satsuma resubmits its NDA for STS101 DHE nasal powder for migraine
Satsuma Pharmaceuticals announced that it has resubmitted its NDA for STS101 intranasal dry powder dihydroergotamine for the acute treatment of migraine with or without aura. The company initially submitted the NDA in March 2023 even though the Phase 3 SUMMIT trial of STS101 failed to meet its primary endpoints. In January 2024, the FDA issued a CRL to the … [Read more...] about Satsuma resubmits its NDA for STS101 DHE nasal powder for migraine
FDA clears Qnovia’s IND for Phase 1 study of QN-01 RespiRx inhaled nicotine
According to Qnovia (formerly Respira Technologies), the FDA has cleared an IND submitted by the company for a trial of its QN-01 RespiRx nicotine inhaler, which the company is developing for smoking cessation. The company says that it plans to initiate the Phase 1 study, which is expected to enroll 24 smokers, by the end of the year. The trial will compare nicotine … [Read more...] about FDA clears Qnovia’s IND for Phase 1 study of QN-01 RespiRx inhaled nicotine
FDA approves FluMist intranasal flu vaccine for self-administration
The FDA and AstraZeneca are both touting the agency's approval of FluMist intranasal influenza vaccine for caregiver administration to children aged 2-17 and for self-administration by adults up to age 49. The agency agreed to review AstraZeneca's sBLA for the self-administration change in October 2023. FluMist will still be available for healthcare provider … [Read more...] about FDA approves FluMist intranasal flu vaccine for self-administration
FDA warns agains use of Green Pharmaceutical’s SnoreStop nasal spray due to microbial contamination
The FDA has advised California-based Green Pharmaceuticals to recall its SnoreStop nasal spray due to "significant microbial contamination in SnoreStop Nasal Spray lot number 2460" detected during an inspection in April 2024 and is warning customers not to use the product. The FDA notes that the homeopathic product is unapproved and that Green previously recalled a … [Read more...] about FDA warns agains use of Green Pharmaceutical’s SnoreStop nasal spray due to microbial contamination