Ocugen, Inc. announced that the FDA has cleared an IND for a Phase 1 trial of OCU500 vaccine for the prevention of COVID-19, which the company licensed from Washington University in St. Louis in 2022. The trial, which will evaluate inhaled and intranasal administration of the vaccine, will be conducted by the NIH's National Institute of Allergy and Infectious … [Read more...] about FDA clears IND for a Phase 1 trial of Ocugen’s OCU500 COVID-19 vaccine via inhalation and nasal administration
Regulatory
Corstasis says that the FDA has accepted its NDA for RSQ-777 bumetanide nasal spray for the treatment of edema
Nevada-based Corstasis Therapeutics announced that the FDA has accepted the company's NDA for RSQ-777 bumetanide nasal spray, a diuretic for the treatment of edema associated with congestive heart failure, kidney disease, and liver disease. The agency assigned a PDUFA target date of September 14, 2025. Corstasis CEO Benjamin Esque commented, “We are pleased … [Read more...] about Corstasis says that the FDA has accepted its NDA for RSQ-777 bumetanide nasal spray for the treatment of edema
FDA approves J&J’s sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of depression
According to Johnson & Johnson, the FDA has approved the company's sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of major depressive disorder in adults who have not responded adequately to a minimum of two oral antidepressants. Administration of Spravato is available only in healthcare settings under a REMS program. Spravato has … [Read more...] about FDA approves J&J’s sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of depression
Newbury’s azelastine / fluticasone nasal spray approved in Norway
Swedish pharma company Newbury Pharmaceuticals announced that its marketing application for Azelastine + Fluticasone Newbury, a generic version of Dymista azelastine / fluticasone nasal spray, has been approved by Norwegian regulators for the treatment of allergic rhinitis. The company said that it has also submitted marketing applications in Sweden, Finland, and … [Read more...] about Newbury’s azelastine / fluticasone nasal spray approved in Norway
GH Research says it has completed studies related to IND hold on GH001 inhaled mebufotenin and announces results of Phase 2a trials
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
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