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With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
Here IQVIA’s Dr Sophie Jouaville discusses the importance of risk minimisation measures, how their effectiveness can be assessed and why transparent reporting of these effectiveness studies is crucial.
Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.
The problem of counterfeit medicines is becoming a tremendous burden to society. An edible security tag affixed to each medicine can provide track and trace measures with dose information and on-dose (in-dose) authentication. Furthermore, it serves as a last line of defence against illicit pharmaceutical products. Young Kim, Associate Head…
A review of the last decade of FDA warning letters finds quality control operations, manufacturing process validation, and data record and integrity are the key points of scrutiny.
bluebird bio’s Zynteglo (betibeglogene autotemcel), a one-time treatment for transfusion-dependent beta-thalassemia, will roll out with a $2.8mn price tag per dose.
In this article, EPR’s Hannah Balfour discusses the recent multi-country monkeypox outbreak, highlighting key developments in the international response.
Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
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.
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
With two knighthoods in the last month, here EPR discusses five developments in the drug development community’s C-suite.
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)
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.
