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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Regs & Legs
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
See how a leading biopharma company used an RMM analyser in parallel to plate counts to find the root cause of periodic bioburden excursions in its water system.
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
To promote the safe and ethical use of genome editing for the treatment of disease and genetic disorders WHO has published the first global recommendations.
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.