Category Archives: Biotech

EMA Invites Comments on Good Biomarker Practice

The European Medicines Agency (EMA) has released a consultation on good genomics biomarker practices. The outcome of the consultation will inform a guideline, which will set criteria to underpin the generation of robust clinical genomic datasets throughout a medicine’s lifecycle,  the choice of genomic techniques and biomarkers, the impact on the relevant study design, and the […]
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Catching Biopharmaceutical Sponsors by Surprise

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge […]
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Biotech Stocks Shaken by Fed Warning

Today’s Financial Times (FT) reports that nearly $40bn was wiped from the biotech market’s value last week (a 6 per cent drop in the Nasdaq biotechnology index) following the Federal Reserve’s identification of biotech shares as a cause for concern. There was some recovery on Friday however when prices rebounded 3 per cent. The US […]
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The Technologies Set to Transform Healthcare

By G. Steven Burrill, CEO, Burrill & Company. The promise of precision medicine is beginning to bear fruit as deadly diseases are made treatable, doctors use genetic information to guide treatment decisions, and the convergence of information, communications, and biological technology reinvents the practice of medicine. The arrival of this new age of medicine has […]
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Strong IP Plans Essential for UK Life Sciences Clusters

By John Dean, Withers & Rogers LLP. Life sciences and biotech research clusters across the UK, including those linked to university research departments are benefiting from an improved funding climate and ongoing consolidation in the pharmaceutical sector. However, as big pharma companies increasingly vie for the best spin-out investment opportunities, those with strategic intellectual property […]
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