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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The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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Clinical Trials
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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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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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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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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.
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New Eli Lilly acquisition to progress potential next-generation pain treatment
The deal will support Eli Lilly and Company to advance non-opioid medicines and expand its pain therapy pipeline.
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CHMP meeting highlights – May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
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Major trial indicates potential of novel hypertension drug
The demonstrated safety and efficacy of the aldosterone synthase inhibitor suggest its potential in helping patients with hypertension to reach their blood pressure goal, according to the data.
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BioNTech pledges major UK investment
BioNTech’s commitment aligns with the UK Government’s Plan for Change, which involves accelerating growth of the pharmaceutical industry.
