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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.
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
Modern technology for signal detection and signal management in PV is pivotal to ensure the patient’s safety.
![Lonza Logo on top of grey building in Basel, Switzerland [Credit: Taljat David / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Lonza-1-300x278.jpg)
![Lonza Logo on top of grey building in Basel, Switzerland [Credit: Taljat David / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Lonza-1-e1654774052980.jpg)
The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System) provides more sensitive detection of non-endotoxin pyrogen contaminants in pharmaceutical preparations.
Here, EPR discusses critical considerations to ensure content uniformity in HPAPI drugs produced using dry techniques.
AstraZeneca's Evusheld (tixagevimab and cilgavimab) provided clinically and statistically significant protection against progression to severe COVID-19 over placebo.
Researchers have identified, for the first time, a sensitive, low-risk, closed-system for the detection of fungal contaminants in cell and gene therapy (CGT) products.
Driven by oncology drug demand, the highly potent active pharmaceutical ingredients (HPAPIs) market is anticipated to grow by $7bn in three years.
Phase I study shows that mRNA-based individualised neoantigen specific immunotherapy (iNeST) vaccines can be used to stimulate T cells to recognise neoantigens in pancreatic cancer patients.
A data collection study provides a product quality dataset that could form the basis of advanced analytical models to predict final product quality.
Here, EPR summarises a recent review, outlining the critical considerations when setting occupational exposure limits (OELs), with a focus on HPAPIs.
Here, Origin’s Rich Quelch explores the potential benefits of basing drug prescription on pharmacogenomic data and how transitioning to such a system could impact the UK’s National Health Service.
![Metformin 500mg white tablets on white background [Credit: LeviMax/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Metformin-nitrosamines-300x278.jpg)
![Metformin 500mg white tablets on white background [Credit: LeviMax/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Metformin-nitrosamines-e1654079013697.jpg)
With recalls on metformin products containing nitrosamines ongoing, a study suggests >80 percent of metformin APIs and final drug products are within safe limits.
With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.
