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August 1, Vol. 29, No. 14

  • Columns

    • Biosimilars and Follow-On Branded Biologics
    • Bruce Mackler
    • With Congressional actions on biosimilar/follow-on biologics approaching, FDA has issued a Guidance regarding the use of pens, jets, and other related injectors (See Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet and Related Injectors Intended for ... more »
    • Novel Alzheimer’s Therapies Gaining Ground
    • Carol Potera
    • The pipeline at Mithridion in Madison, WI, consists of treatments for Alzheimer’s disease and other central nervous system disorders Company scientists are focused on improving first-generation drugs that target muscarinic receptors Although none of the first-generation drugs ever made it ... more »
    • GEN Update on Promising Emerging Biotechnologies
    • GEN is pleased to introduce a new column that will appear throughout the editorial yearIt will highlight emerging university or academic technologies that have future applications in the commercial biotech and pharma arenas GEN first discussed each of these novel ... more »
    • Infectious Diseases a Key MDx Market Driver
    • Kevin Leong
    • Molecular diagnostic tests for infectious diseases are proving to be one of the highest-growing segments of the in vitro diagnostics market Accordingly, companies that participate in the clinical diagnostics industry understand that their market participation might be crucial to their ... more »
    • High-Throughput Nanovolume qPCR
    • David Gelfand
      Kumar Kastury
    • Gene-expression profiling is an integral part of biomarker discovery as well as discovery and validation of new therapeutic targets to support drug development Initially, profiling the intracellular range of transcript abundance relied on hybridization-based technology, such as microarrays or spotted ... more »
    • Single-Use Noninvasive Sensing Technology
    • Jim Furey
    • The practice of integrating bags, tubing, and filters into preassembled, ready-to-use bioprocess solutions is optimized if noninvasive sensing of critical process parameters is part of the package These single-use assemblies frequently require treatment for bio-burden reduction or sterilization by nonthermal ... more »