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Lonza Expands Partnership with US Drugmaker, Boosts Capacity for ADCs

July 25, 2026
Contract manufacturing powerhouse Lonza is set to enhance its capabilities in the production of antibody-drug conjugates (ADCs) through an expanded partnership with a significant U.S. drugmaker. This strategic move, announced this week, underscores Lonza’s commitment to addressing the growing demand for ADCs, which are increasingly pivotal in oncology therapeutics. The expansion not only reflects Lonza’s…

Sanofi unit in Ireland chided by FDA over manufacturing flubs linked to Altuviiio

July 25, 2026
Genzyme Ireland, a subsidiary of Sanofi, has received a Form 483 from the FDA following a recent inspection that revealed significant manufacturing deficiencies. This reprimand underscores the ongoing scrutiny that pharmaceutical manufacturers face regarding compliance with regulatory standards. The issues identified are particularly concerning given that they are associated with Altuviiio, a critical product in…

New Guidelines on Medicines Packaging and Labelling Released

July 24, 2026
New guidelines have been issued regarding the packaging, labelling, and patient information leaflets for medicines, emphasizing the critical need for compliance in the pharmaceutical industry. These guidelines provide a comprehensive framework that outlines the necessary information to be included for both consumers and healthcare professionals, ensuring clarity and safety in medication use. As the regulatory…

New Guidance on Patient Information Leaflets Released

July 24, 2026
The recent release of best practice guidance on patient information leaflets establishes a comprehensive legal framework in accordance with EU and national legislation. This guidance emphasizes the importance of effective information design, ensuring that patient leaflets are not only compliant but also user-friendly and informative. As the pharmaceutical industry continues to prioritize patient engagement and…

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