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Regulatory shift signals potential change for future CGT sector
The cell and gene therapy (CGT) sector must maintain its scientific rigor despite recent changes to US policy and market conditions, says key industry body.
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Novel method could optimise beta-blocker synthesis
The proposed synthesis system offers potential for scalable production of β-blockers, new research suggests.
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NICE concludes decision for two Alzheimer’s treatments
The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper
Here, Vladimir Murovec, Counsel, Osborne Clarke, discusses the European Medicines Agency (EMA)’s latest draft reflection paper and its scientific rationale, regulatory implications and potential impact on biosimilar drug development and manufacturing in the EU.
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Eli Lilly genetic medicine acquisition to address cardiovascular risk
The agreement between Eli Lilly and Company and Verve Therapeutics could lead the way to single treatments that provide a long-term reduction of cardiovascular risk factors.
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Enhancing chromatographic protein purification with light
The method offers an alternative approach for efficient control in affinity chromatography as a separation technique, researchers propose.
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UCB commits major US biologics manufacturing investment
The investment will support the company’s long-term vision for its future manufacturing capacity and medicine pipeline.
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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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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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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.
