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Aradigm Corp.

www.aradigm.com

Latest From Aradigm Corp.

Aradigm's Linhaliq Suffers 'No' For Reducing Time To Exacerbations At US FDA Panel

Discordant results on Phase III primary endpoint in non-cystic fibrosis bronchiectasis patients troubled advisory committee members, although some suggested they would be more open to approval based upon secondary endpoint data on reduction in exacerbation frequency.

Advisory Committees Drug Review

Ciprofloxacin For Bronchiectasis: Can Aradigm Avoid Bayer's Fate At US FDA Panel?

Linhaliq, an inhaled form of ciprofloxacin, appears to raise same efficacy, study design, and resistance concerns as those that resulted in a negative advisory committee review and FDA complete response for Bayer's formulation of the fluoroquinolone.

Advisory Committees Drug Review

Bayer's Inhaled Cipro Cannot Surmount Inconsistent Efficacy Data At US FDA Panel

Advisory committee recommends against approval of dry powder formulation for treating non-cystic fibrosis bronchiectasis due to inconsistent results in Phase III RESPIRE trials and concerns about long-term benefit and antibiotic resistance.

Advisory Committees Drug Review

Bayer's Inhaled Cipro For Bronchiectasis To Face FDA Panel Efficacy Questions

Advisory committee asked to opine on whether there is substantial evidence of efficacy even though Phase III studies missed on three of four primary efficacy measures; Bayer argues that totality of the evidence demonstrates a meaningful benefit in reducing exacerbations in a heterogeneous patient population with the rare disease.

Advisory Committees Drug Review
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Company Information

  • Industry
  • Biotechnology
  • Medical Devices
  • Pharmaceuticals
    • Drug Delivery
      • Pulmonary
  • Therapeutic Areas
  • Neurology, Nervous System
  • Poison (Antidote)
  • Respiratory, Pulmonary
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Aradigm Corp.
  • Senior Management
  • Igor Gonda, PhD, Pres. & CEO
    Nancy Pecota, CFO
    Juergen Froehlich, MD, CMO
  • Contact Info
  • Aradigm Corp.
    Phone: (510) 265-9000
    3929 Point Eden Way
    Hayward, CA 94545
    USA
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