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Beyfortus approved for US infants against RSV disease
The only monoclonal antibody approved for passive immunisation to protect infants in their first RSV season has been approved by the US Food and Drug Administration (FDA).
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Data Analysis
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New data suggests novel mAb could delay progression of early Alzheimer’s
Full results from the “first Phase III study of a disease-modifying therapy to replicate the positive clinical results observed in a previous study” have been published in JAMA.
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NIH spending for drugs approved 2010-2019 lower than industry spending, study finds
The first article to broadly assess the US National Institutes of Health (NIH)'s financial contribution to clinical development of new drugs has been published.
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Safety analysis published for C. diff biotherapeutic
The largest safety evaluation of any microbiota-based live biotherapeutic includes data for up to two years for the first approved microbiome-based treatment for recurrent Clostridioides difficile (C. diff).
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Clinical research organisation market anticipated to reach $140bn by 2033
According to a report, growing demand for cost-effective and efficient drug development processes is propelling the global clinical research organisation (CRO) market.
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Guide to Data Integrity
Welcome to EPR's Guide to Data Integrity. In this edition, Charles River explores the significance of data integrity in pharmaceutical manufacturing, Graeme Bones of ICON considers how to complete database transfer with data integrity considerations at the forefront and Rapid Micro Biosystems® discusses the practical implications of the ‘four-eyes principle’ for pharma…
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Eli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
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FMF World Congress 2023: Janssen shares new data in HDFN
If approved, nipocalimab would be the first anti-FcRn therapy for EU pregnancies at high risk of haemolytic disease of the foetus and newborn.
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How can real-world evidence support regulatory decision making?
Strategies to further accelerate real-world evidence generation to aid EU regulatory decision-making are needed, states a European Medicines Agency (EMA) report.
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Reducing bioburden testing and sterility testing volumes for gene therapies
A reduced sampling plan was recommended in a Biophorum report for reducing required bioburden and sterility testing volumes for gene therapy batch yield.
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New approach for small molecule nanosimilar analysis reported
A study on the small molecule antibiotic rifabutin has highlighted benefits of mechanistic compartmental analysis in evaluating nanomedicines.
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New mass spec technique identified for electron ionisation direct analysis
A paper has depicted extractive-liquid sampling electron ionisation-mass spectrometry (E-LEI-MS) as a new real-time MS technique for direct analysis.
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First-in-class oral small molecule trial data presented at 2023 ERA Congress
At the 2023 ERA Congress, Chinook Therapeutics revealed Phase I data for its first-in-class oral small molecule LDHA inhibitor.
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How effective is nanopore sequencing for fungal identification?
A paper has described a DNA metabarcoding workflow that rapidly characterises fungal microbiota with high taxonomic resolution.
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How can AI be best harnessed for pharmacovigilance data?
A GSK-funded paper on pharmacovigilance stated that the pharma industry needs to harness the properties of data to allow optimal use of AI, otherwise "we will fail to do all we can for patient safety".
