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Nektar Therapeutics

www.nektar.com

Latest From Nektar Therapeutics

US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates

Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.

Neurology Pricing Debate

Opioid-Sparing Hopes, Efficacy Worries Drive Inconclusive Advisory Cmte. On Durect's Posimir

US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.

Advisory Committees Drug Review

One Loss, One Tie: US FDA Panels Prove Difficult For Opioid Sponsors Intellipharmaceutics, Esteve

Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.

Advisory Committees Drug Review

Nektar's Novel Opioid Unanimously Rejected by US FDA Advisory Cmte.

But more data on abuse potential and efficacy could offer path for forward for oxycodegol even after the FDA product-specific advisory committee meeting for an opioid analgesic in more than a year goes very badly for the sponsor.

Advisory Committees Neurology
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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
  • Pharmaceuticals
    • Drug Delivery
      • Macromolecule
  • Therapeutic Areas
  • Cancer
  • Immune Disorders
  • Neurology, Nervous System
  • Alias(es)
  • Inhale Therapeutic Systems Inc.
  • Nektar Therapeutics Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Nektar Therapeutics
  • Senior Management
  • Howard W Robin, Pres. & CEO
    Gil M Labrucherie, SVP, CFO & COO
    Stephen K Doberstein, PhD, SVP, R&D and Chief R&D Officer
    John Northcott, Chief Commercial Officer
  • Contact Info
  • Nektar Therapeutics
    Phone: (415) 482-5300
    455 Mission Bay Blvd. S.
    San Francisco, CA 94158
    USA
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