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MHRA Class 2 medicine recalls – May/June 2025
The UK medicine agency's most recent recalls of this class have been due to packaging and potential contamination issues.
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Biopharma
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Lancet study illustrates drug delivery “milestone”
The oral pill could address common drug adherence challenges in conditions such as schizophrenia, the clinical trial findings suggest.
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FDA grants expanded approval for hepatitis drug
The FDA’s authorisation helps to address the “significant” remaining need for acute hepatitis C treatments, according to AbbVie.
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Construction begins on new WuXi microbial manufacturing site
The new manufacturing site features automation capabilities to ensure efficient production and supports advancement of potential next-generation microbial therapies.
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Multi-billion-pound funding to accelerate UK’s high-growth sectors
The UK Government’s £86 billion announcement will help strengthen innovation and economic growth in key sectors including life sciences.
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Engineering scalable iPSC-NK therapies
Stefan Braam, Chief Technology Officer, Cellistic, explores the manufacturing and regulatory challenges of scalable, off-the-shelf iPSC-NK cell therapies.
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Duchenne gene therapy interim trial outcomes “striking”
The gene therapy demonstrated consistent evidence of positively changing disease trajectory in Duchenne muscular dystrophy, new interim data shows.
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MHRA issues first UK guidance on phage therapies
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
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European Council announces progress on pharmaceutical package adoption
The new EU rules for medicines aims to strengthen EU pharmaceutical competitiveness and reduce the regulatory burden.
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Pharma Horizons: environmental monitoring
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
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BioNTech and BMS partner to advance oncology deal worth over $10 billion
The agreement involves an immunotherapy candidate with potential to innovate treatment of multiple tumour types, stated BMS.
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R&D and tech innovation boosting biopharmaceutical market to 2030
Advanced technology innovation is driving lower R&D costs and progress of targeted treatments such as cell and gene therapies, the research reports.
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Roche reports long-term capabilities of multiple sclerosis drug
The BTK inhibitor enabled near-complete suppression of disability progression for up to two years in individuals with relapsing multiple sclerosis (RMS), the new findings reveal.
whitepaper
Strategies for endotoxin testing of RNA-LNP
Overcome matrix interferences in RNA–LNP endotoxin testing with LAL-based methods & recombinant factor C assays. Learn more in this whitepaper.
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New technology could enhance CAR T therapy manufacture
The innovative device could improve CAR T cell cancer immunotherapy and facilitate its use as a first-line therapy, research suggests.
