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Genentech, Inc.

http://www.gene.com

Latest From Genentech, Inc.

Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures

Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.

Post Market Regulation & Studies Review Pathway

Accelerated Approval: US FDA’s Hammer Falls On Oncopeptides’ Pepaxto

Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.

Post Market Regulation & Studies Review Pathway

Sandoz Enters Canada With First Denosumab Biosimilar

Sandoz has truly established its position as the frontrunner in the denosumab race after a Canadian approval, but the path to the US market has been hindered by a lawsuit from the originator Amgen.

Biosimilars Approvals

Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

Drug Review Profile Biosimilars
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    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Tanox
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