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The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.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.
The investment will support the company’s long-term vision for its future manufacturing capacity and medicine pipeline.
The UK medicine agency's most recent recalls of this class have been due to packaging and potential contamination issues.
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 new manufacturing site features automation capabilities to ensure efficient production and supports advancement of potential next-generation microbial therapies.
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.
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
The new EU rules for medicines aims to strengthen EU pharmaceutical competitiveness and reduce the regulatory burden.