As of 1 October, it was no longer possible to use the eSUSAR website as a means of expediting suspected unexpected serious adverse drug reactions (SUSARs) from clinical trials to the European Eudravigilance Clinical Trial Module, as eSUSAR was decommissioned by the Medicines and Healthcare products Regulatory Agency (MHRA):

mhrainspectorate.blog.gov.uk

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Trinity Investment Management have acquired the Grafton Centre, Cambridge, and are consulting on proposals to re-develop the area into a combination of new life sciences research/laboratory, retail and community amenity space. Cambridge saw £1.21bn of life science related capital raised in 2020 but growth is constrained by lack of lab space:

cambridgeindependent.co.uk & graftoncentreconsultation.co.uk

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The life sciences sector team of global law firm DLA Piper has created a Guide to the main privacy-related issues arising within clinical trials in 25 jurisdictions including extraterritorial applicability of legislation; legal ground for processing personal data; and key-coded clinical trial data:

dlapiperintelligence.com

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A research paper evaluates the impacts of COVID-19 on clinical research in a research-intensive NHS Trust in London and how the embedded research system was adapted and repurposed to support the COVID-19 response:

journals.plos.org/plosone/article?id=10.1371/journal.pone.0256871

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Roche has announced its drug, Gantenerumab, showed no clear benefit in twin trials which explored its impact on memory, problem solving and other cognitive skills in people with early stage Alzheimer’s:

theguardian.com

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The first clinical trials of the Tecovirimat (also known as Tpoxx) monkeypox treatment have been started in the UK by academics from the University of Oxford who were behind the Covid Recovery trial. They are hoping to recruit 500 people:

thenationalnews.com

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IQVIA has entered a long-term partnership with Clalit Health Services to open the first Prime Site in Israel. Clalit operates 14 hospitals and over 1,600 primary care clinics in Israel, and IQVIA provides a software as a service-based (SaaS) clinical data analytics platform for clinical trials:

clinicaltrialsarena.com

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Australian biotechnology company Vaxxas has announced the start of its Phase I clinical trial of a needle-free COVID-19 vaccine, delivered via a high-density microarray patch (HD-MAP), giving potential coverage of all major SARS-CoV-2 variants. If successful in further clinical trials the vaccine patch could be available as early as 2025:

tri.edu.au

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The European Pharmaceutical Review rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022 which took place from 5-7 November:

europeanpharmaceuticalreview.com

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President Joe Biden has issued an executive order to keep U.S.-based innovation ahead of advances made by counterparts in China biotechnology and biomanufacturing:

biospace.com

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According to Grand View Research, the global healthcare contract research organisation (CRO) market size is expected to reach USD 74.7 billion by 2030. The market is expected to expand at a CAGR of 6.5% from 2022 to 2030:

researchandmarkets.com

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Sobi has received emergency use authorisation from the US Food and Drug Administration for the use of arthritis drug Kineret (Anakinra) in the treatment of COVID-19 related pneumonia. The authorisation was based on a Phase 3 trial on hospitalised patients needing supplemental oxygen which showed reduced progression to respiratory failure and mortality:

ns-healthcare.com