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Oct. 15, Vol. 25, No. 18

    • Wall Street BioBeat

      • GEN's Spotlight on Wall Street News
      • The FDA approved Critical Therapeutics' (www. crtx.com) supplemental New Drug Application (sNDA) to manufacture and market Zyflo (zileuton tablets), which is indicated for the prevention and chronic treatment of asthma in patients 12 years of ag ... more »
    • FDA News and Analysis

      • Review of FDA Guidance on Risk Management
      • The FDA Guidance to Industry on Good Pharmacovigilance Practices1 was issued in March. This guidance applies to drugs, including biological products (excluding blood components), and is provided to pharmaceutical industry to clarify the FDA's cu ... more »
    • Feature Articles

      • Molecular Diagnostics as Clinical Tools
      • Gail Dutton
      • Molecular diagnostics is becoming a driving force in drug development. Applications have spread from identifying infections to include screening for cancer, hepatitis, and a variety of genetic disorders, and even tissue screening to minimize the ris ... more »
      • Singapore Attracts Life Science Companies
      • Back in the 14th century, Singapore was called Temasek, or "Sea Town," because it was naturally situated where sea routes met at the tip of the Malay Peninsula. The British in the 18th century strategically made Singapore a naval base to f ... more »
      • Whole Genome Amplification Technologies
      • Mary Addonizio
      • Applications that need accurate replication often require large amounts of high-quality DNA for analysis and archiving. Areas where high fidelity, low mutation whole genome amplification (WGA) is necessary include molecular cloning, single cell anal ... more »
    • Tutorials

      • Optimized Solutions for RNAi Experiments
      • RNA interference (RNAi) is a method for targeted gene silencing. It is a highly valuable and widely used technique for the study of gene function and for drug discovery research. During RNAi, double-stranded short interfering RNAs (siRNAs), consisti ... more »
      • Recipe for Ensuring Process Control Success
      • Master chefs have been using some of the concepts of GLP, GMP, and PAT long before those TLA's existed. I consult master chef Julia Child a lot. Often, I find a recipe that looks deliciousand so easy! Then I discover that ingredient number three ... more »
      • Utilizing Rapid Point-of-Use Protein Assays
      • There has been a need for accurate estimation of sample protein concentration for many years. This was true during the development of early biochemical techniques, such as enzyme reactions, and later for assay of protein concentration in clinical sa ... more »

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GEN Poll

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Biosimilars

Compared to the original biologics, do you think biosimilars run the risks of being less effective and causing more side effects?