The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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The European Pharmacopoeia will put an end to the rabbit pyrogen test in the next five years and encourages industry to adopt the monocyte-activation test instead.
Foreign biotech start-up? Uncle Sam wants you! (Despite the challenging funding application process)
Here, FreeMind Group’s Ayal Ronen explains the application process for funding by US Government agencies, exploring the challenges and potential benefits of applying for non-US entities.
Biopharma and the life sciences ecosystem: putting the foundations in place for a productive partnership
Even now 65 percent of drugs being approved come from biopharma companies and within a decade that is expected to rise to 85 percent. This is great news for a world hungry for new breakthrough treatments. As growth in pre-clinical and clinical work intensifies globally, Ahmed Bouzidi, Vice President of…
Market research suggests the biological indicators segment will retain the largest share of the global sterilisation monitoring market through 2027.
Research suggests that if pharma does not address staff capability gaps and support employee training and development, then there will be a significant impact on productivity.
Market research shows increasing pharmaceutical R&D investment and advances in quality control (QC) technologies will drive pharmaceutical QC market growth.
The ABPI’s 2021 pharmaceutical industry Code of Practice aims to increase transparency, encourage collaboration and improve patient care.
Germany still second largest producer of EU-approved active biopharmaceutical substances, finds report
A new medical biotechnology report shows Germany’s biopharmaceutical industry is thriving with recombinant antibodies being a key focus area.
Pharma 4.0 represents the next step in the evolution of pharmaceutical manufacturing, and is heralded as providing manufacturers with better efficiencies, higher output and quality, as well as flexible production. Here, Dr Saly Romero-Torres highlights some of the key trends in digital transformation and explains why a strong informatics infrastructure…
Graeme Duncan, CEO at ADVANZ PHARMA, discusses how targeted strategic investment within the off-patent sector can add value and enhance choice for patients and healthcare professionals alike, while helping to drive and maintain innovation within the pharmaceutical industry.
New guidance on the licensing of biosimilar products that reduces unnecessary clinical trials is expected to put the UK ahead of Europe and facilitate a boom in these essential life-saving medicines, creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. It could also…
In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.