A striking feature of recent batches of OINDP product specific guidances (PSGs) is the inclusion of … [Read More...] about A Q&A with Copley’s Clair Brooks on alternative BE approaches in new FDA guidance
A Q&A with Copley’s Clair Brooks on alternative BE approaches in new FDA guidance
Human Factors (HF) Considerations for Generic Inhalers Using Off-the-shelf Devices
By Yvonne Limpens, Managing Human Factors Specialist at Emergo by UL While the time to market … [Read More...] about Human Factors (HF) Considerations for Generic Inhalers Using Off-the-shelf Devices
RDD 2024 highlighted an industry in transition
RDD 2024, which took place May 5-9 in Tucson, AZ, USA, brought together more than 530 … [Read More...] about RDD 2024 highlighted an industry in transition
Latest news
Transpire Bio names new VP of Manufacturing & Operations, Chief Commercial Officer, and Head of Quality Assurance
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 … [Read More...] about Transpire Bio names new VP of Manufacturing & Operations, Chief Commercial Officer, and Head of Quality Assurance
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 … [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 … [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 … [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, … [Read More...] about Bespak and H&T Presspart launch new GMP pilot-scale MDI filling line for LGWP propellants
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