Qnovia (formerly Respira Technologies) has announced the initiation of a Phase 1 PK study of its QN-01 inhaled nicotine, which is delivered via the company's RespiRx vibrating mesh inhaler. In October 2024, Qnovia announced that the FDA had cleared an IND for the trial, which is expected to enroll 24 healthy adults who are current cigarette smokers. Results from … [Read more...] about Qnovia initiates Phase 1 trial of QN-01 RespiRx inhaled nicotine
News
Phillips Medisize parent company Molex completes acquisition of Vectura
Phillips Medisize announced that its parent company Molex has completed its acquisition of inhalation CDMO Vectura, which was initially announced in September 2024. According to the announcement, the acquisition covers all of Vectura's assets in addition to its OINDP analysis and development services business, which employs 350 people. Vectura's intellectual property … [Read more...] about Phillips Medisize parent company Molex completes acquisition of Vectura
Arcturus announces the initiation of a Phase 2 trial of ARCT-032 inhaled mRNA therapy for cystic fibrosis.
Arcturus Therapeutics announced that it initiated 2 studies in December 2024, one of which is a Phase 2 MAD trial of ARCT-032 inhaled mRNA therapy in cystic fibrosis patients. The company announced in September 2024 that the FDA had cleared its IND for the study, which is expected to enroll 12 adults with CF who do not benefit from CFTR modulators and will evaluate 3 … [Read more...] about Arcturus announces the initiation of a Phase 2 trial of ARCT-032 inhaled mRNA therapy for cystic fibrosis.
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
Aridis announces that an unnamed pharma company has agreed to acquire AR-501 inhaled gallium
Aridis Pharmaceuticals said that "an undisclosed pharmaceutical company" has agreed to pay $6.5 million plus annual royalty payments for Aridis' AR-501 nebulized gallium for the treatment of chronic lung infections in patients with cystic fibrosis. Aridis said that it expects to receive 50% of the upfront payment by the end of the first quarter of 2025 and the other … [Read more...] about Aridis announces that an unnamed pharma company has agreed to acquire AR-501 inhaled gallium
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
DDL 2024 in review
DDL 2024 drew the largest crowd ever in the 35-year history of the Drug Delivery to the Lung (DDL), with more than 100 OINDP experts attending online and approximately 1,000 attending in person at the Edinburgh International Conference Centre. DDL celebrated its anniversary with a gala dinner, timely podium and poster presentations, and a sold-out exhibition. Hot … [Read more...] about DDL 2024 in review
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