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Latest News

February 2024

A reminder that all ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025, the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU:

ema.europa.eu


Training and supporting materials are available from the European Medicines Agency (EMA) to help users of the CTIS comply with their legal obligations:

ema.europa.eu


Research on the global Clinical Trials Management System (CTMS) market indicates a value of $1.26 bn in 2023, and an anticipated to exponential compound annual growth rate (CAGR) of 16.65%, reaching $3.71bn by 2030:

globenewswire.com


Sano Genetics in Cambridge, UK, has raised $11.4m to shorten the duration – and, therefore, costs - of clinical trials by using AI software to recruit participants:

cambridgeindependent.co.uk.

In related news, consultant Stephen Wunker examines ‘The Promise and Challenge of Deploying AI in Clinical Trials’ using Yseop (pronounced EasyOp), which has offices in Paris, New York and Lyon, as a case study:

forbes.com


Arena International has released the 2024 Edition of its ‘Clinical Trials Supply Handbook’ with features on clinical trials’ operations and logistics, supply chain technology, and cold chain strategies, and a supplier directory:

arena-international.com


The FDA has published draft guidance directing clinical trial sponsors to include race and ethnicity information on their proposed product labelling. Once finalised, this will replace the 2016 draft guidance ‘Collection of Race and Ethnicity Data in Clinical Trials’:

fda.gov


The 25th Clinical Trial Supply (CTS) Europe conference will take place in Barcelona from 6th to 7th March. Pharmaceutical and Biotech companies will have the opportunity to discuss, debate and consider new technologies and processes to streamline supply chain operations:

arena-international.com


2024A meta-analysis of c. 500 clinical trials which took place in New Jersey, USA, from 2017 to 2022 shows increased equity of race/ethnicity reporting and inclusivity of clinical trials, although more needs to be done to ensure that the demographic numbers in these trials match U.S. Census values:

news-medical.net


Results from a Phase III, randomised, placebo-controlled clinical trial of the immunotherapy drug Pembrolizumab have - for the first time in fifty years - demonstrated an overall survival benefit from an adjuvant therapy in kidney cancer:

europeanpharmaceuticalreview.com


Cancer specialist Associate Professor Craig Underhill is leading a program to improve cancer outcomes in regional Victoria, Australia, by 2025 by giving patients access to new treatments via participation in clinical trials:

health.gov.au


Sandoz, a former division of Novartis, is now a standalone company. It will continue to focus on developing generic and biosimilar medicines for the European medicines market, while Novartis plans to drive its business forward with a strategic focus on innovative medicines:

europeanpharmaceuticalreview.com


January 2024

UK Tech News asked health tech leaders for their predictions on what we can expect in the UK’s health tech sector in 2024:

uktech.news


Ten clinical trials to watch in the first half of 2024. Study results from Vertex, Alnylam and Roche could either speed or stall biotech’s recent momentum:

biopharmadive.com


A look at the potential implications for pharma and biopharma companies operating in Europe of the proposed revisions to EU pharma legislation announced by the European Commission:

europeanpharmaceuticalreview.com


In Q1 2023, the European Commission (EC) announced proposed changes to EU pharmaceutical legislation as part of the 2020 Pharmaceutical Strategy for Europe. They impact pharma and biopharma companies operating in Europe. Amendments have since been submitted. This is a very useful overview:

europeanpharmaceuticalreview.com


Johnson & Johnson has agreed to buy drug developer Ambrx Biopharma for $2 billion to gain access to antibody drug conjugates (ADC) which act as “guided missiles” to target cancer cells and minimise damage to healthy tissue:

finance.yahoo.com/news


Novartis has shared positive results from a phase 3 ASC4FIRST head-to-head trial comparing Scemblix (asciminib) against tyrosine kinase inhibitor (TKI) treatment in newly-diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in the chronic phase:

pmlive.com


A look at how clinical trials for rare diseases can be made less complex, costly, and inefficient through the use of virtual collaboration solutions:

impetusdigital.com


A nationwide Taiwanese clinical trial involving more than 3 million pregnancies has discovered that benzodiazepine use during pregnancy was associated with a 69% increased risk of miscarriage:

medicalupdateonline.com


Analysis of electronic medical record data from more than 1.8 million patients in the USA has found a lower risk of new and recurrent suicidal thoughts in those taking Novo Nordisk's Ozempic or Wegovy (semaglutide) compared to those using other weight loss or diabetes medications:

reuters.com


A free report from leading CRO Novotech looks at the latest developments in research for HIV, including long-acting injectables, vaccines, and gene editing. The global HIV clinical trial landscape since 2018 spans over 1,000 trials, led by Asia-Pacific, then Europe and North America:

pharmaceutical-technology.com

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