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Spectrum Pharmaceuticals Inc.

http://www.sppirx.com/

Latest From Spectrum Pharmaceuticals Inc.

Hanmi Seeks To Swim In 'Blue Oceans' As It Expands Globally

At a recent forum in Seoul, an executive of Hanmi Pharmaceuticals, whose novel neutropenia drug has just received a US green light, shares why it is crucial to create "blue oceans" through global innovative drug development and how the Korean firm plans to challenge these markets.

South Korea Business Strategies

Oncopeptides’ Pepaxto Needs New Study To Identify Population That Will Benefit, FDA Panel Says

Advisory committee votes 14-2 that melflufen’s benefit-risk profile is unfavorable in the current accelerated approval indication for fifth-line treatment of multiple myeloma; panel rejects sponsor’s attempt to rely on post hoc analyses to 'carve out' a subpopulation that, it asserts, is responsible for negative overall survival trend in OCEAN confirmatory trial.

Advisory Committees Post Market Regulation & Studies

Poziotinib Fails To Get FDA Panel Support Though Members Not As Dubious As Agency

Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’

Advisory Committees Drug Review

US FDA Panel To Weigh Whether Copiktra’s Benefit-Risk Profile In Hematologic Cancers Has Changed

Adverse trend in overall survival, tolerability concerns, and uncertainty regarding the dose suggest the PI3K inhibitor's benefit-risk profile in its current indications is unfavorable, FDA says. Secura Bio asserts OS data are confounded and safety issues are the same as at initial approval.

Advisory Committees Drug Review
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Allos Therapeutics, Inc.
    • OncoRx
    • Talon Therapeutics, Inc. (Hana Biosciences, Inc.)
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