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Novel pre-filled autoinjector receives EU approval
The EU authorisation offers a new treatment option for acromegaly, providing effective disease control and enabling convenient self-administration.
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Clinical Development
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AbbVie immunology deal to advance potential first-in-class therapy
The new acquisition, worth up to $2.1 billion, gives AbbVie rights to a potential first-in-class drug for B cell-mediated autoimmune diseases.
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Alliance for impact – advancing CGT development in Europe
Cell therapy expert Lindsay Davies, PhD, FHEA, discusses the key considerations for moving the needle to broader adoption of CGTs in Europe.
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Gilead partners to advance novel oral oncology drug
The deal between Gilead Sciences and Kymera Therapeutics could lead to development of safer and more effective cancer treatments.
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Radioligand therapy could address multiple cancer types
The investigational dual-targeting treatment provided strong and durable delivery to tumours, allowing for a high dose of targeted radiation, early results show.
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Streamlining European expansion for cell and gene therapies
Tom Smith, Strategic Director, Cell and Gene Therapies, Uniphar, discusses the essential elements biotechs need for commercial success in Europe’s unique market when developing cell and gene therapies (CGTs).
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iPSC-CAR-NK cell therapy exhibits autoimmune potential
The genetically edited allogeneic product could serve as an immune-modulatory therapy for severe autoimmune diseases, data 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The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.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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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.
