DPI developer Iconovo announced that the company's ICOcap capsule-based dry powder inhaler ICOcap is now CE marked for use in clinical trials. The ICOcap inhaler is available from the Stevanato Group, which signed a manufacturing, sales, and distribution agreement for the inhaler with Iconovo in 2018. Iconovo CEO Johan Wäborg commented, "Getting the CE … [Read more...] about Iconovo’s ICOcap DPI gets CE mark for clinical trial use
Regulatory
Microbion gets orphan designation for pravibismane inhalation suspension for lung infections in CF patients
Microbion Corporation said that its pravibismane inhalation suspension for the treatment of lung infections in patients with cystic fibrosis has been granted orphan drug designation by the FDA. Pravibismane inhalation suspension has already been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations for that indication. According to the … [Read more...] about Microbion gets orphan designation for pravibismane inhalation suspension for lung infections in CF patients
Propeller Health sensor for Symbicort gets 510(k) clearance
Propeller Health announced that the FDA has granted 510(k) clearance for the company's inhaler monitoring sensor for AstraZeneca's Symbicort MDI. The Propeller sensor snaps on to the inhaler and connects via Bluetooth to a mobile app. The company also manufactures sensors for MDIs, DPIs, and SMIs made by GSK, Novartis, Orion, and Boehringer Ingelheim. Propeller … [Read more...] about Propeller Health sensor for Symbicort gets 510(k) clearance
FDA approves Cipla’s generic of Migranal DHE nasal spray with CGT designation
Cipla said that it has received final approval for an ANDA for its generic version of Bausch's Migranal dihydroergotamine (DHE) mesylate nasal spray for the treatment of migraine. According to Cipla, this is the company's first FDA approval for a generic nasal spray; the agency has recently approved an ANDA for Cipla's generic Proventil HFA. The FDA approved the … [Read more...] about FDA approves Cipla’s generic of Migranal DHE nasal spray with CGT designation
Bevespi Aerosphere approved in China for the treatment of COPD
The Chinese National Medical Products Administration (NMPA) has approved AstraZeneca's Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. AstraZeneca's Breztri Aerosphere budesonide/glycopyrronium/formoterol fumarate MDI was approved for the treatment of COPD by the NMPA in December 2019. In June 2019, Bevespi … [Read more...] about Bevespi Aerosphere approved in China for the treatment of COPD
Teva Canada imports supply of UK-branded salbutamol (albuterol) MDIs under interim order
Teva Canada said that it has imported a 4-week supply of Salamol salbutamol (albuterol) sulfate MDIs through Teva UK under an interim order by the Minister of Health in response to shortages of the inhalers in Canada caused by the COVID-19 pandemic. Salamol MDIs are marketed by IVAX Pharmaceuticals in the UK; Teva acquired IVAX in 2006. Health Canada recently … [Read more...] about Teva Canada imports supply of UK-branded salbutamol (albuterol) MDIs under interim order
VistaGen proposes Phase 2a study of PH94B nasal spray for the treatment of anxiety related to the COVID-19 pandemic
VistaGen Therapeutics has announced that it is proposing a Phase 2a study of its PH94B aloradine nasal spray for the treatment of patients with adjustment disorder with anxiety caused by the COVID-19 pandemic, subject to approval by the FDA. The company said that it submitted the proposal through the FDA's Coronavirus Treatment Acceleration Program (CTAP). PH94B … [Read more...] about VistaGen proposes Phase 2a study of PH94B nasal spray for the treatment of anxiety related to the COVID-19 pandemic
Verona moving ahead with planning for Phase 3 study of nebulized ensifentrine after receipt of FDA comments
Verona Pharma says that the FDA's comments in response to the data from a Phase 2 study of the company's RPL554 nebulized ensifentrine for the treatment of COPD support moving ahead with a Phase 3 clinical program. The Phase 3 program, called ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy), is planned for later this year. In January 2020, Verona … [Read more...] about Verona moving ahead with planning for Phase 3 study of nebulized ensifentrine after receipt of FDA comments
Pulmotect gets FDA okay for two Phase 2 trials of PUL-042 for the prevention and treatment of COVID-19
Pulmotect said that it plans to initiate two Phase 2 trials of its PUL-042 immunostimulant inhalation solution for the prevention and treatment of COVID-19 within a week after getting the go-ahead from the FDA. In January 2020, the company announced that preclinical studies of PUL-042, which is made up of Toll-like receptor agonists, demonstrated that it could protect … [Read more...] about Pulmotect gets FDA okay for two Phase 2 trials of PUL-042 for the prevention and treatment of COVID-19
FDA approves IND for Phase 2 study of GeneOne Life Science nasal spray for the prevention of COVID-19
The FDA has approved an IND for a Phase 2 study of GeneOne Life Science's GLS-1200 nasal spray for the prevention of COVID-19, the company said. According to GeneOne, GLS-1200 stimulates nasal production of nitric oxide, which has been shown to inhibit coronavirus activity. The study of GLS-1200 for prevention of COVID-19 is expected to enroll 225 healthcare … [Read more...] about FDA approves IND for Phase 2 study of GeneOne Life Science nasal spray for the prevention of COVID-19