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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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Regulation & Legislation
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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Effective data management: lessons to learn from Big Pharma
Here, Frits Stulp and Duncan van Rijsbergen of Iperion explore how startups can establish the most efficient data management processes and systems, avoiding the kind of mistakes made by Big Pharma.
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EU adopts electronic product information standard for medicines
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
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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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Green chemistry
Here, Dave Elder reflects on the pharma industry’s efforts to get greener; highlighting the confounding issues that mean it is not always easy to achieve.
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Recommendations published on medicine procurement across the EU
The EFPIA has published 10 recommendations to ensure that procurement practices across the EU are effective and sustainable, delivering high quality medicines for patients, in the right quantities and at the right time.
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Pharmaceutical industry seeks to build public trust with new data principles
A new framework for how the pharmaceutical industry will use health data for research and development of cutting-edge new medicines has opened for consultation.
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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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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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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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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.
whitepaper
Whitepaper: Analysing water purity for advanced chromatographic applications
Download this whitepaper to find out how the purity of bottled water compares to the purity of water produced by an ELGA water purification system.
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NICE recommends first treatment for children with metachromatic leukodystrophy
The one-time gene therapy treatment for rare, neurodegenerative disease metachromatic leukodystrophy (MLD) is the most expensive drug ever evaluated by NICE.
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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.
