Almirall Launches Phase III Clinical Programme for COPD Therapy
The Phase III programme involves approximately 3,500 patients with moderate to severe COPD and consists of two large pivotal studies.
Spanish pharmaceutical company Almirall, S.A., together with its US partner Forest, initiated a Phase III clinical programme of the fixed dose combination (FDC) of aclidinium bromide and formoterol fumarate twice daily (BID) delivered in the Genuair? inhaler, for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).
The Phase III programme involves approximately 3,500 patients with moderate to severe COPD and consists of two large pivotal studies -one conducted mainly in Europe and another in North America- evaluating the efficacy and safety of the FDC of aclidinium plus formoterol during 24 weeks, as well as a long-term safety study of 52 weeks which is also performed in North America.
Protocols of these clinical trials have been desi
Related News
-
News Understanding the Benefits and Advances of Cleanroom Technology
In an industry where precision and sterility are crucial concerns, cleanrooms play a vital role in maintaining the integrity of pharmaceutical products like drugs, vaccines, and other medical products. So, what is a cleanroom?
-
News AbbVie secures GBP£1.2 billion deal for Gilgamesh’s psychedelic programme
AbbVie has penned a significant agreement to acquire the bretisilocin programme from Gilgamesh Pharmaceuticals for up to £1.2 billion, marking a bold step in the pharmaceutical giant's quest to develop treatments for psychiatric disorders. -
News Gates Foundation commits US$2.5 billion to women’s health research
The Bill & Melinda Gates Foundation has announced a substantial US$2.5 billion commitment to accelerate research and development focused exclusively on women's health through 2030.
-
News Mid-year review: notable FDA drug approvals of 2025
As we fly past the halfway point of 2025, the pharmaceutical landscape reliably continues to evolve with innovative therapies addressing critical medical needs. The FDA has already approved 17 groundbreaking medications this year, each representin... -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News Google-backed start-up raises US$600 million to support AI drug discovery and design
London-based Isomorphic Labs, an AI-driven drug design and development start-up backed by Google’s AI research lab DeepMind, has raised US$600 million in its first external funding round by Thrive Capital. The funding will provide further power t... -
News AstraZeneca to invest US$2.5 billion in Beijing R&D centre
Amid investigations of former AstraZeneca China head Leon Wang in 2024, AstraZeneca have outlined plans to establish its sixth global strategic R&D centre in China. Their aim is to further advance life sciences in China with major research and manufact... -
News Experimental drug for managing aortic valve stenosis shows promise
The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience.