Tag Archives: biomarkers

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 […]
Posted in Biotech, Europe, Global, Regulatory | Also tagged , | Leave a comment

Challenges to the Specialty Business Model

By Emily O’Connor, Jillian Scaife, and Ryan P. Million Biopharmaceutical drug discovery companies have progressively tailored their pipelines to specialty therapeutic areas and smaller patient populations. However, the specialty business model has lately shown signs of strain and outright constraints in continued scalability. Agents such as Gleevec, Zaltrap, and Sovaldi have been under fire from […]
Posted in Biotech, Market Access, Strategy | Also tagged , , | Leave a comment

Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
Posted in FDA, Gene therapy, Legal, Market Access, R&D, Regulatory, Technology | Also tagged , , , , , , , , | Leave a comment

Woodcock Urges Forward March Toward Personalized Medicine

New approaches for conducting clinical trials and developing therapies that actually prevent and cure disease are key to the future of effective drug therapy, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). Personalized medicine has achieved mainstream status, accounting for more new drug approvals and promising pipeline candidates, […]
Posted in Technology | Also tagged , , , , , , , , , , | Leave a comment
  • Categories

  • Meta