New working party to address excipients in Ph. Eur. monographs
The European Pharmacopoeia Commission’s new Excipients Strategy Working Party will address specificities of excipients in European Pharmacopoeia monographs.
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The European Pharmacopoeia Commission’s new Excipients Strategy Working Party will address specificities of excipients in European Pharmacopoeia monographs.
Research has revealed efficiency of a multi-compartmental dissolution method used to predict in vivo performance of BCS Class IIa compounds.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, including an enzyme replacement therapy for a rare disease.
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
In a Phase II trial, immunotherapy drug pembrolizumab significantly lowered the risk of recurrence for stage III-IV melanoma patients when given before and after surgery.
CPI, AstraZeneca, Novartis, and The University of Manchester will collaborate to facilitate large-scale manufacture of oligonucleotides.
Here, Mark Dickman, Professor in Bioanalytical Science and Engineering at the University of Sheffield, explores how analytical techniques such as liquid chromatography-mass spectrometry can support the manufacturing of mRNA therapeutics.
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
An all in-one system purpose-built for rapid deployment, ease of use and scalability in markets where time-to-results is critical.
CaliberBRM is a manufacturing product suite that digitalises and automates pharmaceutical manufacturing processes for a paperless, future-ready lab.
A key issue faced in pharmaceutical laboratories is the integration and standardisation of data from the array of instruments. Here, Samantha Kanza from the University of Southampton outlines some challenges with using laboratory information management systems or other digital tools. How might these be overcome?
In a Phase III trial, a new cell therapy has shown potential for the first time to treat inflammation, a major contributor to heart failure.
A PEGylated enzyme replacement therapy for Fabry disease has received recommendation for a marketing authorisation from the European Medicines Agency (EMA)'s human medicines committee.
Between 2022 and 2035, the bioavailability enhancement services market will see an 11 percent compound annual growth rate, a report has predicted.
If approved, the cream formulation of the JAK inhibitor ruxolitinib will be the first treatment for repigmentation in non-segmental vitiligo available in the European Union.