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CPHI to return to Milan in 2024
CPHI, the global pharmaceutical exhibition will take place in Milan, Italy from 8-10 October 2024.
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Active Pharmaceutical Ingredient (API)
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Antibiotic manufactured via continuous-flow for first time
Continuous-flow manufacturing of the antibiotic cefazolin can cover mass production within compact manufacturing facilities and contribute to a stable drug supply, researchers have reported.
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Paper reports on QbD in bilayer tablet development
A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
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EMA prepares for winter antibiotic shortages
Anticipating similar demand of antibiotic use in prior winter seasons, the European Medicines Agency (EMA) has proposed key actions to mitigate supply chain issues.
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FDA releases analysis on drug product quality in 2022
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
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UK trial to test psilocin-based drug for major depressive disorder
A first-of-its-kind trial testing a novel psilocin-based drug for major depressive disorder has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
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FDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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New AMR certification launched for antibiotic manufacturers
Following publication of the Antibiotic Manufacturing Standard in 2022 to help overcome AMR, antibiotic manufacturers can now verify their actions through a new certification.
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Analysis reports nitrosamine prevalence in small molecule drugs
Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
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Automation to guide technology shift in aseptic environments
Referencing Annex 1–2022, a paper has described how automation will be implemented in aseptic environments in view of regulatory requirements.
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European Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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Could ATR-FT-IR spectroscopy become ‘gold standard’ for heparin analysis?
A paper states ATR-FT-IR spectroscopy plus multivariate analysis for heparin analysis is cost-effective compared to NMR.
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Eli Lilly promises additional $1.6b manufacturing investment
A total $3.7 billion investment at LEAP Innovation Park in the US is Eli Lilly and Company’s largest manufacturing investment at a single location in its history.
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Navigating delivery challenges of nucleic acid therapeutics
A paper has reviewed how novel drug delivery systems could achieve stable formulations of nucleic acid therapeutics.
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Collaboration to produce 3D screen printed pharmaceuticals
A new collaboration between two industry players for cGMP production of 3D screen printing technologies could reduce drug development costs.
