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orphan diseases

This page shows the latest orphan diseases news and features for those working in and with pharma, biotech and healthcare.

PMEA 2020: continuing to recognise excellence in improving patient outcomes

PMEA 2020: continuing to recognise excellence in improving patient outcomes

Excellence in Rare Diseases and Orphan Drugs categories. ... with support from Learner Adams Bones Ltd. 8. Excellence in Rare Diseases and Orphan Drugs.

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  • Listen, learn and lift off Listen, learn and lift off

    The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are expecting a busy year for approvals, with frantic activity in orphan diseases as gene and cell therapy ... That has completely changed and we’re now launching

  • Piloting a route to the biosimilars opportunities in Europe Piloting a route to the biosimilars opportunities in Europe

    Biological medicines represent a major advance in the treatment of serious pathological conditions such as cancer, neurodegenerative and autoimmune diseases, in the form of biosimilars. ... For orphan designations (medicine for rare diseases),

  • Assessing the impact of disease prevalence on access and pricing of rare disease drugs in England Assessing the impact of disease prevalence on access and pricing of rare disease drugs in England

    Comparison of orphan drug assessments from NICE versus the NHS. The question of how to adequately capture the holistic value of orphan drugs (ODs) for rare diseases is the subject of ... to drugs targeting ‘very rare’ diseases (typically ultra-orphan

  • Biopharma and orphan drugs Biopharma and orphan drugs

    Rare disease regulations. Twenty one of the 48 novel drugs approved in the US were for rare or orphan diseases – those that affect fewer than 200, 000 citizens. ... Clinical complications. Given the rarity of orphan diseases, one of the greatest

  • Industry needs an aligned position on the future of the EU OMP Regulation Industry needs an aligned position on the future of the EU OMP Regulation

    The Pharmaceutical Strategy is likely to include innovation-boosting measures and plans to revise the EU Regulation on Orphan Medicinal Products (OMP Regulation). ... of orphan diseases).

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