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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 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.
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.
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.
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.
The innovative device could improve CAR T cell cancer immunotherapy and facilitate its use as a first-line therapy, research suggests.
The deal will support Eli Lilly and Company to advance non-opioid medicines and expand its pain therapy pipeline.
