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Regulators commit to collaborating on RWE integration
Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.
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US Food and Drug Administration (FDA)
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What can we learn from contamination control failures?
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
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Developing a holistic approach to cardio, metabolic and renal disease
With cardiovascular disease continuing to present a significant health concern, European Pharmaceutical Review’s Hannah Balfour reflects on recent development efforts and drug approvals in the space with comment from Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland.
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Nitrosamine drug substance-related impurities (NDSRIs)
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
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Pharmaceutical C-suite update
With two knighthoods in the last month, here EPR discusses five developments in the drug development community’s C-suite.
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The importance of sterility testing in biopharmaceutical manufacturing
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
![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)
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Majority of metformin drugs have acceptable nitrosamine levels, finds study
With recalls on metformin products containing nitrosamines ongoing, a study suggests >80 percent of metformin APIs and final drug products are within safe limits.
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Early phase CGT trials: key design elements correlating to distinctive biological characteristics
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.
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The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
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Advancing extractables and leachables testing
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
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Engaging the innate immune system to fight cancer effectively
Most therapeutic approaches in immuno-oncology focus on targeting the adaptive immune system; innate immunity has only recently gathered momentum. One of the most potent receptors for activating innate immune cells such as natural killer cells and macrophages is CD16A. Addressing this target mimics the body’s natural defense against potential threats,…
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Setting a new standard of care for liver MRI contrast agents in patients with reduced kidney function
A ‘hot’ topic on the radar of radiologists in recent years has been the safety of the potentially toxic gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI). This is especially pertinent in the detection of focal liver lesions for patients with poor kidney function due to potentially fatal…
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Draft guidance to improve US clinical trial diversity
The new clinical trial guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.
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FDA approves first drug for PIK3CA-Related Overgrowth Spectrum (PROS) conditions
Novartis’ Vijoice® (alpelisib) is the first and only treatment approved for the treatment of the rare spectrum of conditions associated with PROS in certain patients.
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Teva recalls one lot of IDArubicin Hydrochloride Injection USP
Lot 31329657B of Teva’s IDArubicin Hydrochloride Injection USP 5mg/5ml vials is being recalled across the US due to particulates.
