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Genentech Inc.

Division of Roche
www.gene.com

Latest From Genentech Inc.

US OTC Switch Drought Ends: FDA Approves GSK Arthritis Gel, Alcon Allergy Eye Drops

FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.

OTC Drugs Prescription To Otc Switch

Keeping Track: Seqirus Pandemic Flu Vaccine Approved; Trevena Resubmits Oliceridine

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point

Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.

Pink Sheet Perspectives User Fees

Keeping Track: Aimmune’s Peanut Allergen Approved; Novartis’ Inclisiran, Pfizer/Lilly’s Tanezumab, Bayer’s Nifurtimox Submitted

Highlights of the latest drug development news from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals
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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
    Levi J Garraway, CMO & Head, Global Product Dev.
  • Contact Info
  • Genentech Inc.
    Phone: (650) 225-1000
    1 DNA Way
    S. San Francisco, CA 94080
    USA
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