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Omeros Corporation

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Latest From Omeros Corporation

US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters

COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.

Complete Response Letters Drug Approval Standards

Finance Watch: Financial Market Turmoil Ends Amicus SPAC Deal For Gene Therapy Spinout

Public Company Edition: As their stock prices plummet, Adagio reshuffles its research plan and names a new CEO, while Yumanity restructures and seeks strategic alternatives. Also, Bristol sells $6bn worth of notes, Amgen issues $750m green bond, and Inhibrx and Amryt amend and refinance debt.

Financing Business Strategies

US FDA Novel Approvals Grew To 60 In 2021; CDER Cleared 50 New Agents, Turned Down 18

Approval total is one of FDA’s highest, but the large number of complete response letters obscures the staggering total of almost 80 new molecular entities and novel biologics that the agency acted on over the year.

Approvals US FDA Performance Tracker

Deal Watch: Lilly Teams With Regor On Metabolic Disorders

Chinese firm RareStone licenses Rhythm’s Imcivree in greater China and will help enroll label-expansion studies for the drug. Omeros sells ophthalmic surgery drug Omidria and its commercial team to Rayner Surgical Group.

Deal Watch Business Strategies
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  • Biotechnology
    • Large Molecule
      • Antibodies
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