Category Archives: Biotech

Sponsor–CMO Relationships: Critical Issues

Eric Langer assesses the results of a recent survey of what biopharm companies want from CMOs. Contract manufacturing organizations (CMOs) should have the technical expertise to be considered by clients for partnerships. It’s no longer enough for them to lay claim to technology, regulatory compliance, and IP protection expertise, as these increasingly become non-negotiable issues, according […]
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Biosimilar Development in Europe: Ten Years On

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, […]
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Risk and Innovation in Biopharma: A CEO’s Perspective

In this Applied Clinical Trials article, Kadmon CEO Dr. Sam Waksal talks about the importance of imagination for innovation, current business risks in biopharma, and applying understanding to the concept of Big Data. Click here for the article.
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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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