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EMA’s human medicine committee (CHMP) meeting highlights, July 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
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Regulation & Legislation
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
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.
whitepaper
Case study: 7000RMS & process control strategy
Learn how Mibelle Group improved their process control strategies using the 7000RMS analyser in parallel with validated plate counts.
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Whitepaper: Cleaning validation
This whitepaper discusses cleaning validation and the considerations required for a successful outcome.
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Whitepaper: Learn about biofilm in hot WFI
This paper explores the presence of biofilm in hot WFI systems and the use of rapid microbial methods to overcome the limitations of plate counts.
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Strengthening the pharma industry’s cyber security defence
Cyber hackers target businesses of all shapes and sizes, but the pharmaceutical industry remains a prime target, especially as these companies undergo digital transformation and move high value data online. But how can the industry protect itself from the threat of cyber attack? Jack Garnsey, Product Manager at VIPRE SafeSend…
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
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FDA suggests principles for implementing bio-fluorescent particle counters
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.
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WHO publishes recommendations on human genome editing
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.
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Rabbit pyrogen test to be replaced by European Pharmacopoeia
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.
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IL-6 antagonists reduce risk of death in hospitalised COVID-19 patients, finds analysis
WHO recommends IL-6 antagonists plus corticosteroids for hospitalised COVID-19 patients based on their ability to reduce risk of death and the need for mechanical ventilation.
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Nitrosamines: the latest position
Timelines for assessing the potential for contamination of medicinal compounds with nitrosamines have been revised. Here, Dave Elder explains the EMA’s and FDA’s positions and the likely scenarios to be encountered.
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MHRA and Health Canada release new clinical safety reporting guidance
Under the new guidance, Development Safety Update Reports must include a description of the process used to review the worldwide safety data of the investigational drug.
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EU approves Opdivo plus Yervoy for colorectal cancer
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for certain metastatic colorectal cancers after a trial found the combination meaningfully improved response rates.
whitepaper
Technical bulletin: An updated approach to E&L testing per ISO 10993-18:2020
ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
