AstraZeneca and Avillion have announced that the Phase 3b BATURA trial of Airsupra albuterol / budesonide MDI as a rescue inhaler in patients with mild asthma met its primary endpoint of reduction in risk of severe exacerbation compared to albuterol alone. The companies say that the independent data monitoring committee recommended an early termination of the trial … [Read more...] about Phase 3b BATURA trial of Airsupra albuterol / budesonide MDI meets primary endpoint
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Aero Pump and Resyca launch Ultra Soft Nasal Pump Spray device
German spray pump manufacturer Aero Pump and soft mist inhaler developer Resyca have announced a partnership for the development and launch of a device called the Ultra Soft Nasal Pump Spray, which is now available for licensing. In January 2024, Resyca parent companies Recipharm (now Bespak) and Medspray announced that they had added development of soft mist nasal … [Read more...] about Aero Pump and Resyca launch Ultra Soft Nasal Pump Spray device
Liquidia acquires additional rights to Pharmosa’s liposomal treprostinil inhalation suspension
Liquidia Corporation will pay Pharmosa $3.5 million up front plus as much as $157.75 million in milestone payments to extend their existing agreement related to L606 inhaled liposomal treprostinil for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The deal also includes a license … [Read more...] about Liquidia acquires additional rights to Pharmosa’s liposomal treprostinil inhalation suspension
FDA clears Qnovia’s IND for Phase 1 study of QN-01 RespiRx inhaled nicotine
According to Qnovia (formerly Respira Technologies), the FDA has cleared an IND submitted by the company for a trial of its QN-01 RespiRx nicotine inhaler, which the company is developing for smoking cessation. The company says that it plans to initiate the Phase 1 study, which is expected to enroll 24 smokers, by the end of the year. The trial will compare nicotine … [Read more...] about FDA clears Qnovia’s IND for Phase 1 study of QN-01 RespiRx inhaled nicotine
Transpire Bio announces initiation of Phase 1 study of generic inhaler for asthma and COPD
Transpire Bio has announced the initiation of its clinical program for a generic inhaler for the treatment of asthma and COPD. The company did not specify which of its pipeline products has been advanced into Phase 1. According to Transpire Bio's web site, the company's pipeline includes both a DPI and an MDI for asthma/COPD in addition to a DPI and SMIs for COPD. … [Read more...] about Transpire Bio announces initiation of Phase 1 study of generic inhaler for asthma and COPD
InCarda says development of FlecIH-103 flecainide inhalation solution will continue despite early termination of Phase 3 trial
According to InCarda, data from the Phase 3 RESTORE-1 trial of FlecIH-103 flecainide inhalation solution for aroxysmal atrial fibrillation (PAF), which was initiated in July 2022, support continued development despite the early termination of the study due to disappointing efficacy and plasma concentrations. InCarda cites delivery problems with the jet nebulizer used … [Read more...] about InCarda says development of FlecIH-103 flecainide inhalation solution will continue despite early termination of Phase 3 trial
ARS launches Neffy nasal epinephrine nasal spray in the US
ARS Pharmaceuticals has launched Neffy epinephrine nasal spray in the US, the company said. In Auguest 2024, Neffy was approved by the FDA for the treatment of anaphylaxis in patients who weigh 30 kg or more. Earlier this month, ARS submitted an sNDA for a lower dose of Neffy for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs). European … [Read more...] about ARS launches Neffy nasal epinephrine nasal spray in the US
Fagron gets rights to use PureIMS’s Cyclops DPI with compounded inhalation powders in the Netherlands
PureIMS has announced that personalized medicine company Fagron has acquired exclusive rights to distribute PureIMS's Cyclops dry powder inhaler with compounded inhalation powders in the Netherlands. The Cyclops DPIs, which are pre-filled with drug, will be dispensed by compounding pharmacy Infinity Pharma. According to the announcement, the deal includes … [Read more...] about Fagron gets rights to use PureIMS’s Cyclops DPI with compounded inhalation powders in the Netherlands
Vistagen initiates Phase 3 PALISADE-4 trial of fasedienol nasal spray for social anxiety disorder
Vistagen has announced the initiation of the Phase 3 PALISADE-4 trial of fasedienol pherine nasal spray in people with social anxiety disorder (SAD). According to the company, the PALISADE-4 trial is similar to the PALISADE-3 trial, which was initiated earlier this year. Both of those studies have protocols that are similar to the PALISADE-2 trial, which the company … [Read more...] about Vistagen initiates Phase 3 PALISADE-4 trial of fasedienol nasal spray for social anxiety disorder
Iconovo reports positive feedback from the FDA regarding its ICOpre DPI and reacquisition of rights to the ICOone device
DPI developer Iconovo said that the FDA "has issued a positive guidance regarding the generic substitutability of the company's proprietary inhaler ICOpre with the original drug Breo Ellipta with respect to external design and operating principles" and indicated that the device is suitable for an ANDA for a generic of Breo Ellipta fluticasone furoate/vilanterol DPI. … [Read more...] about Iconovo reports positive feedback from the FDA regarding its ICOpre DPI and reacquisition of rights to the ICOone device