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Innovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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Personalised medicine
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Patient centricity for tailor-made healthcare
In this Q&A, EPR talks with health access specialist Dr Michal Davidescu about patient centricity, it’s impact on drug development considerations and why it’s essential to help treat our diverse and evolving global population.
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FDA approves innovative gene therapy for MLD
Following US FDA approval of Lenmeldy™ (atidarsagene autotemcel) for early-onset metachromatic leukodystrophy (MLD), the US wholesale acquisition cost of the gene therapy has been set to $4.25 million.
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Innovation to drive advanced drug delivery market
The advanced drug delivery market is anticipated witness a compound annual growth rate (CAGR) of 4.6 percent by 2033, according to a report.
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Novel immunotherapy approved for melanoma
The first non-CAR-T adoptive cell therapy to reach the market has been approved by the US Food and Drug Administration (FDA).
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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics
Here, Chief Technical Officer, Mike Frodsham and Ryan Wilson, Head of Microbiome Services at SGS Quay Pharma, explore the chemistry, manufacturing, and control (CMC) challenges of developing drug products containing live anaerobic bacterial strains, used for treatments such as microbiome therapeutics.
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Pharma Horizons: Artificial Intelligence
EPR's inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
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Developing point-of-care CAR T manufacturing
Driven by technological advances there is now increased scope for point-of-care manufacturing of CAR T-cell therapy. Arnon Nagler, Professor of Medicine at Tel Aviv University, discusses key benefits, challenges and lessons learned from developing an in-house programme.
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New approach for synthesis of oligonucleotide conjugates
Researchers from Aarhus University and Novo Nordisk have discovered a new synthesis method for oligonucleotide conjugates, marking a step forward in development of more targeted RNA medicines.
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Innovative technologies facilitate novel contamination-detection method
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
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Navigating challenges in HPAPI development and manufacturing
12 October 2023 | By Thermo Fisher Scientific (Patheon)
HPAPIs now account for more than half of clinical small molecule NCE drugs. Learn from our experts how to overcome the most common challenges in HPAPI handling.
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European Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
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FDA approval for Janssen’s prostate cancer treatment
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
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Could novel gene therapy treat sickle cell disease?
Researchers have revealed positive preliminary data from a CRISPR gene therapy trial for sickle cell disease.
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Machine learning can predict outcomes for inkjet printed pharmaceuticals
A paper has shown how machine learning (ML) models predicted the inkjet printing printability of drug formulations with high accuracy.
