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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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Regulation & Legislation
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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.
whitepaper
Whitepaper: Digital transformation of medical devices sterilisation by EtO
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
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Automating microbial methods for data integrity in the modern age
“Continuous improvement” is a buzz phrase in the biopharmaceutical industry. Despite its reference in numerous regulatory and guidance documents, resistance to improvement remains strong in microbiological quality control.
whitepaper
Application note: Software that makes data integrity compliance visible
Read this application note to discover the software that makes data integrity compliance visible: Shimadzu LabSolutions database (DB) or client/server software (CS).
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Application Notes Supplement 2021
Here, industry experts share their research, guidance and pharmaceutical knowledge.
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What are the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines?
In response to the COVID-19 pandemic caused by the SARS-CoV-2 virus, the emergence of RNA vaccine technology has enabled rapid development of critical vaccines. Traditional vaccine production methods makerapid development challenging, requiring cell line production of viral proteins and laborious purification development, which requires extensive effort and long timelines. RNA…
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Article: Survey of the status of rFC and LAL equivalence determination
While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
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ICH M13: Bioequivalence guidelines
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
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Enabling compliant data management with a comprehensive informatics solution
Learn about how SampleManager LIMS software drives compliance and data integrity by providing clear traceability for all laboratory activities and data.
news
FDA approves Actemra for emergency use in hospitalised COVID-19 patients
The monoclonal antibody Actemra (tocilizumab) was approved for emergency use in hospitalised paediatric and adult COVID-19 patients based on results from four clinical trials.
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Making use of those ‘in the know’
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.
news
Collaboration working to promote health research, development and innovation
A strategic European health research and innovation agenda is being compiled by five industry associations and the European Commission.
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EMA human medicines committee meeting highlights, June 2021
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
