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With almost every aspect of pharmaceutical regulation currently under review across Europe and the proposal for changes expected in December 2022, in this article, Maarten Meulenbelt, Partner at Sidley Austin LLP, discusses with European Pharmaceutical Review some of the more controversial amendments under consideration and emphasises why industry participation is…
Marking the initiation of its African vaccine manufacturing network, BioNTech begins construction of its hub site in Rwanda.
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
With two knighthoods in the last month, here EPR discusses five developments in the drug development community’s C-suite.
Cleanroom and laboratory managers need to collaborate to set their employees up for success. They must also be willing to review their procedures even when it seems an employee is responsible for an error.
Researchers find that heparin affinity chromatography (HAC) produces highly pure extracellular vesicles with greater recovery than existing purification methods.
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need for data integrity in life sciences and how costs can be reduced but patient safety increased, and Charles River showcase their services and how they stand…
In this issue experts explore the development of targeted protein degradation drugs, how potential legislative changes may impact the EU and selecting the right downstream process for bi-specific antibodies. Also featured in this journal, how RMM can enable efficient shutdown recovery, five critical areas for data integrity in life sciences…
According to IFPMA, the World Trade Organization decision to waive intellectual property rights for COVID-19 vaccines fails to tackle the biggest barrier to access: trade.
Researchers suggest full evaporation static headspace gas chromatography (FE-SHSGC) could be a universal method for the analysis of semi-volatile nitrosamines in pharmaceutical products.
The standard requires antibiotics manufacturers to have effective environmental management systems in order to minimise pharma’s role in spread of environmental antimicrobial resistance (AMR).
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
The pandemic has been a game-changer for the pharmaceutical industry, sending the seemingly inexorable globalisation trends into reverse, with Big Pharma increasingly seeking more domestic supply chain options. Here, Karen Winterhalter of Onyx Health shares her expert insights on the impact of this emerging trend on the industry.
Sanofi announces first Digital Accelerator to develop products and solutions that foster the use of digital, data and artificial intelligence.
