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£260mn in funding to support UK clinical research and medicines manufacturing
The UK Government has committed £200mn to support NHS-led diagnostics and treatment research and £60 million to expand life sciences manufacturing.
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Clinical Development
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UK to support early-stage clinical research with £161 million
New funding for Clinical Research Facilities will boost delivery of first-in-human to early safety and efficacy trials across England.
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Radiomolecular precision oncology: a comprehensive treatment approach with high potential
A significant obstacle still faced in oncology is damage to healthy cells inflicted during treatment, which robs patients of their quality of life while battling cancer. Targeted radionuclide therapy (TRT) is a type of radiomolecular precision oncology that addresses this issue by deploying cancer-killing radiation directly to tumour cells, with…
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Application Note: Challenges and practical solutions for switching to prefilled syringes for injectables
There are several end-product formats companies can choose from when developing sterile injectable drugs. The most common ones are liquid or lyophilized vials, prefilled syringes, and cartridges. Due to an increase in self-administration of injectable drugs, the market of drug products in prefilled syringes is expected to reach $9.53 billion…
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FDA aims to advance non-addictive opioid alternatives for acute pain management
The U.S. Food and Drug Administration (FDA) has taken new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction.
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Nexviazyme® improves respiration and mobility long-term in Pompe disease patients
Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility.
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DARWIN EU® Coordination Centre to integrate real-world evidence into medicines regulation
EMA will establish the DARWIN EU® Coordination Centre to develop and manage a network of real-world healthcare data sources across the EU.
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Phase I oncology studies: rule- versus model-based design
In this article, Karen Ooms, Head of Statistics at Quanticate, compares the rule- and model-based approaches to Phase I trial design, exploring their benefits and weaknesses in defining maximum tolerated dose for oncology products.
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New regulation strengthens role of EMA in EU crisis response
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.
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Clinical trial trends – what will 2022 bring?
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.
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Understanding the new EU Clinical Trial Regulation: seven things sponsors should know
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.
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New studies look to assess immunogenicity of Omicron-based vaccines
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.
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International regulators call for multivalent COVID-19 vaccines
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
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Study finds Keytruda® improves overall survival in HCC patients
The data adds to the body of evidence relating to the use of Keytruda® as a monotherapy in second-line HCC post sorafenib.
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Imfinzi™ plus tremelimumab: “unprecedented survival” in unresectable liver cancer
Almost a third of unresectable hepatocellular carcinoma patients were alive at three years on tremelimumab and Imfinzi regimen.
