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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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QA/QC
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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.
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QA/QC & Analytical Techniques In-Depth Focus 2019
This in-depth focus includes features that examine how microbiologists can advance their methods of study, discuss the regulatory guidelines regarding genotoxic impurities and explore Raman spectroscopy as a non-invasive analysis technique.
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EMA releases findings from pharmacovigilance report
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
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ICH M9: biopharmaceutics classification system-based biowaivers
ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
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European Pharmaceutical Review Issue 6 2019
In this issue are articles that explore the impact of M&As within the life science industry, discuss the security trends for medicinal packaging and investigate genotoxic impurities within pharmaceutical products. Also included are features on nanobot drug delivery systems and Raman as an effective analytical approach.
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Drug approved which reduces risk of cardiovascular events
The FDA has approved Vascepa (icosapent ethyl) as a secondary therapy to reduce cardiovascular events in adults.
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Medical cannabis: face-to-face with Dr Zeid Mohamedali
Dr Mohamedali discusses Canada's stance on medical cannabis and breaks down some misconceptions surrounding cannabinoids, as well as exploring the future for the pharmaceutical ingredient.
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EMA recommends five drugs for approval after December meeting
The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
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FDA grants accelerated approval for treatment of rare DMD mutation
The FDA has granted accelerated approval to Vyondys 53 for the treatment of patients with Duchenne muscular dystrophy containing a mutation of the dystrophin gene that is amenable to exon 53 skipping.
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The global cannabinoid pharmaceutical industry
Cannabinoids are of growing interest in the pharmaceutical industry. Mark Tucker explains how this class of compounds is viewed across the world and why regulations surrounding them hinder their progress, yet remain necessary.
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EC approves treatment for severe osteoporosis postmenopausal women
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
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Pelosi’s drug pricing bill passes House of Representatives
The House of Representatives has voted to approve Speaker Pelosi’s drug pricing bill in a Democrat-led chamber, say reports.
