Irish biopharm company GH Research said that it has completed inhalation toxicology studies of GH001 inhaled mebufotenin (5-MeO-DMT) necessary to address the FDA's 2023 clinical hold on an IND that the company had submitted for a Phase 1 study of GH001 for the treatment of treatment-resistant depression. In addition, the company announced that 2 Phase 2a proof of … [Read more...] about GH Research says it has completed studies related to IND hold on GH001 inhaled mebufotenin and announces results of Phase 2a trials
Regulatory
ARS Pharma files for regulatory approval of neffy epinephrine nasal spray in Canada and in the UK
ARS Pharmaceuticals announced that it has submitted marketing applications for neffy epinephrine (adrenalin) nasal spray in Canada and in the UK. The nasal spray has been approved in the US and in Europe (as EURneffy) for the treatment of anaphylaxis in adults and in children weighing ≥30 kg since August 2024. In November 2024, ALK-Abelló acquired the rights to market … [Read more...] about ARS Pharma files for regulatory approval of neffy epinephrine nasal spray in Canada and in the UK
Endo recalls epinephrine nasal solution after FDA determination that the product is misbranded
Endo USA has recalled all unexpired lots of Adrenalin Chloride Solution epinephrine nasal solution, which is meant for topical application, due to FDA concerns about the potential for confusion of the product with the company's Adrenalin epinephrine for injection. As a result of the potential for confusion, Endo said, "FDA has determined the product to be misbranded … [Read more...] about Endo recalls epinephrine nasal solution after FDA determination that the product is misbranded
Appeals court upholds ruling requiring delisting of Teva ProAir HFA device patents from Orange Book
The US Court of Appeals for the Federal Circuit has upheld a ruling from district court that requires Teva to remove patents covering inhaler device and dose counter IP from the FDA's Orange Book. In the decision issued on December 20, 2024, the appeals court says, "to qualify for listing, a patent must claim at least what made the product approvable as a drug in the … [Read more...] about Appeals court upholds ruling requiring delisting of Teva ProAir HFA device patents from Orange Book
Savara initiates rolling BLA submission for Molbreevi molgramostim inhalation solution for the treatment of aPAP
Savara announced that it has initiated a rolling biologics license application submission for its Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company said that it will request priority review of the application when the submission is complete, which is expected in the first quarter of 2025. … [Read more...] about Savara initiates rolling BLA submission for Molbreevi molgramostim inhalation solution for the treatment of aPAP
PureIMS’s Colistin Cyclops DPI gets orphan designation from both the EMA and FDA
According to PureIMS, both the EMA and FDA have recently granted orphan drug designation to the company's Colistin Cyclops dry powder inhaler for the treatment of P. aeruginosa infections in cystic fibrosis patients. Colistin Cyclops is currently in Phase 1 development and is available in the Netherlands for the treatment of pulmonary P. aeruginosa infections as a … [Read more...] about PureIMS’s Colistin Cyclops DPI gets orphan designation from both the EMA and FDA
ARS says regulatory submissions for neffy epinephrine nasal spray have been filed in China, Japan, and Australia
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
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