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Gilead announces primary endpoints met in Phase III remdesivir trial
Gilead has said that topline results for clinical recovery have been demonstrated in a Phase III trial of remdesivir, tested in COVID-19 patients.
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QA/QC
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Four MHRA ‘inspections and good practice’ guidances for the COVID-19 outbreak
Md Saddam Nawaz discusses four guidances released by the MHRA to help firms navigate the regulatory waters during the COVID-19 pandemic.
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From commensalism to parasitism: the dangers of underestimating cleanroom bacterial contaminants
Marc Baiget Francesch explains how commensal bacteria can be opportunistic pathogens and why treating them as merely a light threat to cleanrooms can bring disastrous consequences.
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How modern chromatography data systems are improving regulatory compliance in pharmaceutical manufacturing
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
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Native liquid chromatography coupled to mass spectrometric analysis for the assessment of higher order structures of proteins
The accurate measurement of the molecular mass of proteins is an essential component of protein characterisation. In this article, Ioannis Papayannopoulos discusses the applications of native protein chromatography coupled to mass spectrometry to enable the characterisation of tertiary structures and non-covalent interactions.
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FDA sends two warnings to companies selling unapproved CBD products
Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
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Supportive therapy better than novel treatments for COVID-19, say scientists
Instead of using new or repurposed treatment for COVID-19, doctors should focus on traditional critical care principles for patients, scientists have said.
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Application of liquid chromatography in characterisation of lipid nanoparticle-based oligonucleotides
Duplex oligonucleotides (OGN) with lipid nanoparticles (LNPs) as delivery vehicles for different therapeutic indications are of great interest in pharma, exemplified by the recent approval of Onpattro from Alnylam Pharmaceuticals. Liquid chromatography is an essential analytical technique in the characterisation of LNPs containing OGNs. This brief review is intended to…
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Video: More efficient Cleaning Validation with Sievers TOC
TOC analysis in the lab, at-line, or online enables efficiency gains and process understanding for cleaning validation and monitoring programs.
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Fresenius Kabi recalls 13 lots of ketorolac tromethamine injection
The FDA has announced that Fresenius Kabi is voluntarily recalling 13 lots of ketorolac tromethamine injection due to particulate matter found in reserve sample vials.
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Research focus should remain on high quality studies during COVID-19 pandemic, say scientists
Exceptions to high quality research should not be made simply because of the COVID-19 pandemic, argue scientists in a new commentary.
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EMA warns about side effects of chloroquine and hydroxychloroquine for COVID-19 treatment
The COVID-19 European Medicines Agency (EMA) pandemic Task Force (COVID-ETF) warned that chloroquine and hydroxychloroquine are yet to be proved effective at treating COVID-19 and that their side effects could be fatal.
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Developing a COVID-19 biosensor for faster diagnostics and environmental monitoring
A team have developed a biosensor with high specificity and sensitivity for COVID-19 that could be used in hospitals, train stations or laboratories to detect SARS-CoV-2.
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Avet recalls tetracycline HCl capsules to consumer level
The company announced the voluntary recall is due to low, out of specification dissolution test results in specific batches of its tetracycline products.
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Guide to Testing
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Eurofins, Associates of Cape Cod, Inc. (ACC), SGS Life Sciences and Nelson Labs showcase their unique testing services and discuss how they stand out from the competition.
