Inhaled drug developer Transpire Bio has announced the hires of Timothy Lutz as VP of Manufacturing and Operations; Stuart Loesch as Chief Commercial Officer; and Todd Sunstrom as Head of Quality Assurance. The company recently announced the initiation of a Phase 1 trial for a generic inhaler for asthma and COPD. Last October, Transpire officially opened its new … [Read more...] about Transpire Bio names new VP of Manufacturing & Operations, Chief Commercial Officer, and Head of Quality Assurance
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Honeywell announces agreement to supply HFO 1234ze for DevPro albuterol MDI, spin off of the advanced materials business
Honeywell announced that it has signed a long-term supply agreement with DevPro Biopharma related to the use of Honeywell's Solstice Air HFO-1234ze in DevPro's DP007 albuterol metered dose inhaler. Earlier this year, DevPro and CDMO Bespak announced that they were collaborating on development of the LGWP propellant MDI. Recipharm, which later spun out Bespak, and … [Read more...] about Honeywell announces agreement to supply HFO 1234ze for DevPro albuterol MDI, spin off of the advanced materials business
A Q&A with Copley’s Clair Brooks on alternative BE approaches in new FDA guidance
A striking feature of recent batches of OINDP product specific guidances (PSGs) is the inclusion of strategies for the demonstration of bioequivalence (BE) that eliminate the need for a clinical endpoint trial. Copley Applications Specialist Clair Brooks discusses evolving test methods within this context, notably realistic aerodynamic particle size distribution … [Read more...] about A Q&A with Copley’s Clair Brooks on alternative BE approaches in new FDA guidance
Aptar acquires SipNose nasal delivery technology
Aptar Pharma announced that it has acquired nasal delivery technology from Israeli nasal drug developer SipNose Nasal Delivery Systems. In addition to developing devices, SipNose has a pipeline of candidates developed in-house and candidates in development with partners, such as Noveome's ST266 secretome. According to Aptar, the company has acquired all of … [Read more...] about Aptar acquires SipNose nasal delivery technology
Bespak and H&T Presspart launch new GMP pilot-scale MDI filling line for LGWP propellants
CDMO Bespak, which spun out from Recipharm earlier this year, and device company H&T Presspart have announced that a new pilot-scale GMP line for filling MDIs with lower global warming potential (LGWP) propellants HFA-152a and HFO-1234ze is ready to begin manufacturing at Bespak's Holmes Chapel, UK, site. The two companies announced in April 2024 that they had … [Read more...] about Bespak and H&T Presspart launch new GMP pilot-scale MDI filling line for LGWP propellants
Phase 3b BATURA trial of Airsupra albuterol / budesonide MDI meets primary endpoint
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
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