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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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.
The proposed synthesis system offers potential for scalable production of β-blockers, new research suggests.
The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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.
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.
The method offers an alternative approach for efficient control in affinity chromatography as a separation technique, researchers propose.
Industry experts, Remco Jan Geukes Foppen, Vincenzo Gioia, Alessio Zoccoli and Carlos Velez reflect on the necessity to ensure data quality in order to gain full advantage from multimodal language models (MLMs).
The oral pill could address common drug adherence challenges in conditions such as schizophrenia, the clinical trial findings suggest.
The FDA’s authorisation helps to address the “significant” remaining need for acute hepatitis C treatments, according to AbbVie.
The UK Government’s £86 billion announcement will help strengthen innovation and economic growth in key sectors including life sciences.
The gene therapy demonstrated consistent evidence of positively changing disease trajectory in Duchenne muscular dystrophy, new interim data shows.
The new EU rules for medicines aims to strengthen EU pharmaceutical competitiveness and reduce the regulatory burden.
The agreement involves an immunotherapy candidate with potential to innovate treatment of multiple tumour types, stated BMS.
Advanced technology innovation is driving lower R&D costs and progress of targeted treatments such as cell and gene therapies, the research reports.
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.