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The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
This whitepaper explores the conflict that exists between necessary administration tasks and innovation, demonstrating how digitalisation can help.
US FDA approves Cabenuva (cabotegravir, rilpivirine) based on results from the ATLAS-2M Phase IIIb trial which showed every-two-month dosing was non-inferior to once-monthly dosing.
Transiently infecting tobacco plants, researchers were able to produce recombinant proteins that could be developed into COVID-19 vaccines.
![Pfizer logo on a sign in New York city, US [Credit: Molly Woodward / Shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-4-300x278.jpg)
![Pfizer logo on a sign in New York city, US [Credit: Molly Woodward / Shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-4-e1627904909506.jpg)
Dr William Pao will assume his role as Executive Vice President and Chief Development Officer at Pfizer in March 2022, replaced at Roche by Dr Hans Clevers.
New pre-clinical research demonstrates the potential of gastric autoinjectors to deliver mRNA in sufficient quantities for vaccination.
Here, EPR’s Hannah Balfour examines the trends that look set to shape clinical research in 2022, with comment from Aman Khera, VP and Global Head of Regulatory Strategy at Worldwide Clinical Trials.
Take the quiz and journey through the interactive tool to find out about water purity in healthcare and pharma.
New data from the BioIndustry Association (BIA) and Clarivate has shown an increase of 60 percent, to £4.5bn in UK biotech funding in 2021, which is largely the result of overseas investment.
Market capitalisation (MCAP) for the top bio/pharma companies grew 24.9 percent in 2021, with BioNTech and Moderna entering the top 20 for the first time.
New report finds the UK’s life science sector needs more experienced staff with digital skills to support R&D and advanced medicines manufacturing.
Lorviqua® monotherapy approved as first-line advanced non-small cell lung cancer therapy based on promising Phase III trial results.
Moderna and IAVI take steps towards HIV vaccination, with initiation of a trial dosing patients with HIV immunogens delivered by mRNA.
In this article, Sarah Bly and Aman Khera of Worldwide Clinical Trials break down the seven key differences between the EU Clinical Trial Directive and new EU Clinical Trial Regulation, discussing when and how sponsors should begin submitting their trials through the new CTIS portal system.
A new clinical study by Pfizer Inc. and BioNTech SE, and Phase II study by Moderna, are seeking to evaluate the immunogenicity and safety of Omicron-based vaccines and boosters.
