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Chikungunya vaccine candidate safe and immunogenic in Phase III
Valneva’s single-shot chikungunya vaccine candidate, VLA1553, offered a very high level of seroprotection in all adults, including the elderly.
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Clinical Trials
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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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Empagliflozin benefits adults hospitalised for acute heart failure, shows study
Phase III trial shows that adults hospitalised for acute heart failure were 36 percent more likely to experience a clinical benefit if initiated on empagliflozin.
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Nirsevimab first potential immunisation to protect against RSV in infants
Nirsevimab has the potential to offer RSV protection for all infants, with a single dose showing 74.5 percent efficacy in the Melody Phase III trial.
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Clostridioides difficile vaccine shows promise in Phase III trial
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
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FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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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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β-thalassemia patients achieve transfusion independence with gene therapy
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
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EU pharmaceutical regulatory outlook for 2022
How will a new regulatory landscape impact the EU and UK pharma industries? Early 2022 will see major new clinical trial legislation come into effect, with proposals for an entirely new regulatory regime promised by the end of the year. Paul Ranson, Consultant at Morgan Lewis, reflects on this and…
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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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European Pharmaceutical Review Issue 1 2022
In our latest journal, discover the innovations enabling drugs to be delivered across the blood-brain barrier, the challenges associated with downstream purification of cell and gene therapies, as well as applications of NIR spectroscopy in ingredient analysis. Also featured in this issue, explore the development and future potential of radiomolecular…
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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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NICE approves Wegovy™ (semaglutide) for obesity
New draft guidance means thousands of obese Brits could benefit from Novo Nordisk’s Wegovy™ (semaglutide), a drug shown to improve weight loss.
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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.
