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FDA announces US recall of mirtazapine tablets due to mislabelled strength
Aurobindo Pharma USA, Inc. has issued a voluntary nationwide recall of certain mirtazapine tablets as bottles labelled as 7.5mg may contain 15mg tablets.
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NICE issues draft guidance, finding negative opinion for volanesorsen
Waylivra (volanesorsen) has not been recommended for treatment of familial chylomicronaemia syndrome, according to draft guidance from NICE.
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Over 250 drug list prices increased in 2020, says new report
Drug makers have hiked the price of over 250 drugs in the US so far in 2020, according to new reports.
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Lynparza approved by FDA to treat germline BRCA-mutated metastatic pancreatic cancer
The FDA has approved Lynparza as a first-line treatment after it reduced the risk of disease progression or death by 47 percent in patients.
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EMA announces launch of collaborative pilot scheme to inspect manufacturers
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
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MHRA announces recall of Medley Pharma ranitidine tablets
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
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Genotoxic impurities in pharmaceutical products
Several organisations have developed guidelines that specifically address genotoxic impurities in pharmaceutical products. Here, Dr Sol Bobst and Gowri Sukumar discuss the regulatory landscape, testing requirements and calculation methods for occupational exposure limits.
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Learning from clinical microbiologists: culturomics and metagenomics
Clinical microbiologists have started using new, non-conventional methods to study the microbiology of the human gut. In this article, Jeanne Moldenhauer discusses the intricacies of culturomic and metagenomic studies and how this can advance current research.
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Exploring Raman: a non‐invasive analytical approach
Since it was discovered in the 1920s, Raman spectroscopy has been used in pharmaceutical research as a non‐invasive way to provide chemical and structural information in situ, without any staining or complicated sample preparation. Nikki Withers spoke to Professor Kishan Dholakia to hear more about its use in industry and…
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Lumasiran drug achieves primary and secondary endpoints in Phase III study
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.
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Application Notes & Whitepapers 2019
Industry experts share their latest research and developments in pharma.
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EPR’s news round-up 2019: the stories that defined the year
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
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Expert view: Utility of 3D Raman imaging for pharmaceutical studies
Raman microscopy is well suited to pharmaceutical studies, including the analysis of drug delivery systems and their performance.
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Expert view: Automation in endotoxin testing: new applications using recombinant horseshoe crab Factor C (rFC) reagents with robotics
Sustainable reagents based on recombinant horseshoe crab Factor C (rFC) provides advances in endotoxin testing.
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Expert view: Transforming analytical workflows with Transmission Raman
Over the last decade, Transmission Raman spectroscopy (TRS) has been increasingly implemented in pharmaceutical laboratories as a highspeed, accurate, quantitative analysis solution.
