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Genentech Inc.

Division of Roche
www.gene.com

Latest From Genentech Inc.

Samsung Bioepis Data Suggest Clinical Impact From Herceptin Product Quality Drift

Post hoc data from a long-term safety study of Samsung’s trastuzumab biosimilar and Genentech’s reference product suggest event-free survival rates differ based on a shift in one of Herceptin’s key quality attributes; Genentech said it proactively alerted health authorities when the shift was detected and the evidence does not indicate a clinical impact on patient outcomes.

Biologics Biosimilars

Biosimilars: US FDA Favors Quality Range Testing For Comparative Analytical Assessments

New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving biosimilar sponsors more flexibility.

Biosimilars Drug Approval Standards

Finance Watch: Q1 Numbers Suggest A Brisk VC Deal Pace For Cell And Gene Therapies In 2019

An Alliance for Regenerative Medicine (ARM) report shows big Q1 numbers for venture capital and partnership deals. Also, mid-May VC deals surge globally across therapeutic areas, Biogen pushes back against a bargain-hunting investor and recent public company financings.

Financing Regenerative Medicine

Ark Bio Of China Bets On Untapped Pediatric Antiviral Market Where Few Have Succeeded

Founded five years ago, Shanghai-based Ark Bio sees big potential in the less crowded pediatric antiviral treatment market. Now the start-up is in Phase II development for its lead asset ziresovir for respiratory syncytial virus (RSV) infection, which was licensed from Roche.

Research and Development Strategies Infectious Diseases
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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Pharmaceuticals
  • Therapeutic Areas
  • Cancer
  • Gastrointestinal
  • Immune Disorders
  • Infectious & Viral Diseases
  • Metabolic Disorders
  • Musculoskeletal & Connective Tissue Disorders
  • Neurology, Nervous System
  • Ophthalmic
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Roche
  • Senior Management
  • Alexander Hardy, CEO
    Ed Harrington, CFO
    Sandra J Horning, MD, EVP, Global Dev. & CMO
  • Contact Info
  • Genentech Inc.
    Phone: (650) 225-1000
    1 DNA Way
    S. San Francisco, CA 94080
    USA
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