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Regs & Legs
Pharmacovigilance regulation in the EU and beyond has continued to grow and become more stringent over the last decade. In this article, ICON’s Graeme Bones explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.
Sandoz’s monoclonal antibody Tyruko® has been approved for all indications of reference medicine, as the first biosimilar to treat relapsing forms of multiple sclerosis (MS) in Europe.
A paper has highlighted a technology system for achieving drug traceability compliance and help prevent production of counterfeit drugs.
The first IL-23p19 targeted biologic recommended by the National Institute for Health and Care Excellence (NICE) for moderately to severely active ulcerative colitis (UC) in adults in Great Britain is based on Phase III evidence of sustained clinical remission.
New recommendations from a report on antibiotic use and development has underlined key actions to help mitigate antimicrobial resistance (AMR) globally.
The first long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition, has been approved in the European Union (EU).
The US Food and Drug Administration (FDA) has granted approval of a treatment for anaemic patients with a rare blood cancer.
New tax compliance cost and transfer pricing proposals from the European Commission (EC) aim to support simpler, clearer and more cost-effective tax systems in the EU.
To support small and medium-sized enterprises (SMEs) in the current economic climate, newly proposed measures aim to provide short-term relief, increase long-term competitiveness, and improve equality in the business environment across the Single Market.
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.