insys Therapeutics' epinephrine nasal spray for the treatment of anaphylaxis has received Fast Track designation from the FDA, the company said. In June 2018, Insys said that a Phase 1 study of the nasal spray showed that its bioavailability was similar to that of intramuscular formulations. The company has several OINDPs in development, including a dronabinol … [Read more...] about Insys gets Fast Track designation for its epinephrine nasal spray
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MVP says it believes it can meet FDA requirements for Penthrox IND
Medical Developments International (MVP), which announced in July 2018 that it was expecting a clinical hold letter from the FDA regarding its US clinical program for its Penthrox methoxyflurane inhaler, said that it has now received the letter from the FDA and believes that the company can satisfy the FDA's requirements. According to MVP, the FDA is requiring the … [Read more...] about MVP says it believes it can meet FDA requirements for Penthrox IND
Iconovo appoints Mikael Ekström as VP of Development
Device developer Iconovo AB has announced the appointment of Mikael Ekström as its new VP, Development effective September 1, 2018. Ekström held various positions at AstraZeneca over a period of almost 30 years, most recently as Senior Director Inhalation Product Development. Iconovo said that Ekström's hire "is an important reinforcement of Iconovo's organization … [Read more...] about Iconovo appoints Mikael Ekström as VP of Development
Product Quest recalls nasal sprays sold at major US retailers
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
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