Product Quest manufacturing, which recently announced a recall of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa, has now recalled all of the nasal products it manufactured at its Florida facility "out of an abundance of caution." The company provided a 63-page document listing over1,000 … [Read more...] about Product Quest recalls nasal sprays sold at major US retailers
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Impel initiates Phase 1 trial of INP105 intranasal olanzapine
Impel NeuroPharma said that the first subject has been dosed in a Phase 1 study of INP105 intranasal dry powder olanzapine, which the company is developing for the treatment of acute agitation in bipolar I disorder and schizophrenia. The "SNAP 101" PK/PD trial will compare 3 doses of INP105 to 5 mg and 10 mg doses of intramuscular Zyprexa and to 10 mg of orally … [Read more...] about Impel initiates Phase 1 trial of INP105 intranasal olanzapine
Disappointing results for Phase 3b study of Bevespi Aerosphere
AstraZeneca has announced that the Phase 3b AERISTO trial of Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for moderate to very severe COPD failed to meet 2 out of 3 of its primary endpoints, including non-inferiority to umeclidinium/vilanterol on trough FEV1 and superiority on peak FEV1. Bevespi Aerosphere did demonstrate non-inferiority on peak … [Read more...] about Disappointing results for Phase 3b study of Bevespi Aerosphere
Inhaled xenon gas for PCAS gets fast track designation
The FDA has granted fast track designation to NeuroproteXeon (NPXe) and Mallinckrodt’s inhaled xenon gas for the treatment of post-cardiac arrest syndrome (PCAS), the companies said. A Phase 3 trial of inhaled xenon for that indication is expected to get underway in the next few months. NPXe’s Xenex inhaled xenon has received orphan drug designation from the FDA … [Read more...] about Inhaled xenon gas for PCAS gets fast track designation
Impel initiates Phase 3 study of intranasal DHE for migraine
Impel NeuroPharma said that the Phase 3 STOP-301 safety and tolerability study of INP104 intranasal dihydroergotamine (DHE) for the treatment of migraine has gotten underway, with the first patient dosed. The company announced plans for the study in June 2018. According to Impel, recruitment for the study, which will gather data at 24 weeks and 52 weeks of … [Read more...] about Impel initiates Phase 3 study of intranasal DHE for migraine
Vectura announces results from two studies of VR647 in pediatric asthma patients
Vectura has announced results from a pharmacokinetic study of its VR647 nebulized budesonide inhalation suspension in asthma patients aged 4 to 8 and a methodology study of the use of a mouthpiece with the VR647 nebulizer (the Akita Jet nebulizer) by children aged 1 to 4. In January 2017, Vectura announced that it had received FDA approval of its IND for pediatric … [Read more...] about Vectura announces results from two studies of VR647 in pediatric asthma patients
Catalent completes acquisition of Juniper Pharma Services
Catalent will continue to offer DPI development and manufacturing services at the Nottingham, UK Juniper Pharma Services facility that was part of its recently completed acquisition of Juniper Pharmaceuticals, the company says. Catalent announced its intent to acquire Juniper in July 2018. The Nottingham facility was originally owned by Molecular Profiles, which … [Read more...] about Catalent completes acquisition of Juniper Pharma Services
Evoke’s NDA for Gimoti accepted for review by the FDA
Evoke Pharma has announced that the FDA has accepted the company's 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, which Evoke submitted in June 2018. The PDUFA date has been set for April 1, 2019. In a separate letter, the agency also informed Evoke that it had conditionally … [Read more...] about Evoke’s NDA for Gimoti accepted for review by the FDA
FDA accepts NDA for Duaklir, sNDA for Tudorza
According to Circassia Pharmaceuticals, the FDA has accepted its NDA for the Duaklir aclidinium/formoterol DPI for the treatment of COPD and an sNDA for the Tudorza aclidinium bromide DPI, with a PDUFA date of March 31, 2019 for both applications. The Tudorza sNDA requests to add COPD exacerbation reductions and cardiovascular safety data to the prescribing … [Read more...] about FDA accepts NDA for Duaklir, sNDA for Tudorza
Adherium launches Hailie inhaler sensor in US
Adherium recently received OTC clearance for its Hailie inhaler monitoring platform in the US, and the company says that it has now launched direct-to-consumer sales through a web site. Hailie includes an inhaler sensor and a smartphone app that allows patients to monitor their own inhaler use, and a new web portal will provide health care providers with access to … [Read more...] about Adherium launches Hailie inhaler sensor in US