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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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R&D
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First RNA CAR-T therapy autoimmunity trial shows potential
A novel RNA CAR-T cell therapy demonstrated long-term clinical benefit for most generalised myasthenia gravis (gMG) patients in a landmark study.
news
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.
news
Gene therapy approved for Duchenne muscular dystrophy
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.
news
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.
article
AMR certification: recognising responsibly in antibiotic manufacture
Following the recent launch of the BSI’s AMR certification, EPR invited Steve Brooks from the AMR Industry Alliance and BSI’s Courtney Soulsby to elucidate its significance for antibiotic manufacturers and the wider pharma industry.
news
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.
news
First adult anti-inflammatory cardiovascular drug approved
An FDA-approved anti-inflammatory drug can reduce cardiovascular disease risk by an additional 31 percent in adults, on top of standard of care, clinical data has shown.
video
Video: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
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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.
whitepaper
Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
news
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.
news
Could novel robotic oral pill replace traditional injections?
An osteoporosis study has demonstrated a high delivery success rate for a breakthrough technology that converts injections into an oral pill, data from ENDO 2023 showed.
news
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".
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Digitalisation of the clinical trial landscape
UCB Pharma's Chief Medical Officer Iris Loew-Friedrich, shares her perspective on digital innovation in clinical trials plus current challenges in clinical data management and how it could evolve in the future.
