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February 2022

The Clinical Trial Regulation (CTR) came into force in the European Union on 31 January 2022 and, with it, the Commission guidelines on Good Manufacturing Practice for investigational medicinal products for human use (more commonly known as the revised Annex 13 of EU GMP). The new EU CTR will not be applicable in the UK where requirements will remain unchanged pending completion of the consultation on new proposals for the future of UK clinical trial legislation:


Cambridge data company Qureight has raised £1.5 million in seed funding to develop what is described as the world’s only AI-powered platform dedicated to complex diseases. The technology has the potential to reduce dramatically the costs of bringing life-saving drugs to the market and shorten clinical trials:


The Novavax Covid jab has become the fifth approved for use in the UK and is licensed as a two-dose schedule for over-18s. It involves molecules from a rare South American tree and cells from the immune systems of moths. A worldwide clinical trial of 50,000 participants found it to be 100% effective in preventing “moderate and severe disease” from the coronavirus:

www.nursinginpractice.com/clinical/vaccinations-and-infections/two-dose-novavax-covid-vaccine-approved-for-use-in-uk and www.pressandjournal.co.uk/fp/lifestyle/health-and-wellbeing/3790254/how-does-novavax-covid-vaccine-work

On 27 January Moderna announced that volunteers had received the first doses of its experimental mRNA-based HIV vaccine, mRNA-1644, as part of a phase 1 trial to test the safety and efficacy of this approach:


In a ground-breaking development for paralysed people, the revolutionary peptide-based injectable NV-291 treatment for spinal cord injury is set to undergo Phase II clinical trials in Chicago later this year:


Advances in imaging that can map a virus's atomic structure offer new hope in treating some of the trickiest diseases, such as the deadly Crimean-Congo haemorrhagic fever:


COVID-19 diagnostics, therapeutics and vaccines are powerful reminders: health technologies can help to shape the way in which societies control disease. The first step in achieving that is a clearer articulation of what R&D in the global public interest is:


Eurofins Clinical Testing Lux Snarl, a subsidiary of Eurofins Scientific, has acquired Genetic Testing Service SC, the market leader in specialised genetic testing in Vietnam:


Data from human trials of India’s first home-grown mRNA COVID-19 vaccine, which is being developed by Pune-based Gennova Biopharmaceuticals, are likely to be presented to authorities for evaluation by the end of this month, with the product launched before April:


The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) is publishing a three-part blog reflecting on learnings about prioritising the processing and reviewing of all applications for COVID-19 therapeutics and vaccines trials during the pandemic.

This is part 1: mhrainspectorate.blog.gov.uk/2022/02/08/regulators-experience-of-clinical-trials-during-the-covid-19-pandemic-part-1-our-initial-response

The industry is moving rapidly to embrace decentralized clinical trials (DCTs), but there are key areas of uncertainty as to how DCTs sit within the legal and regulatory framework. This article from Baker McKenzie looks at some aspects to be aware of, but should not be construed as legal advice:



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