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Latest From Brenda Sandburg
US FDA Reorg Emphasizes Office of Therapeutic Biologics and Biosimilars
Final reorganization structure includes new office within OND to coordinate review of biologics and biosimilars applications, as well as new oncology and hematology divisions.
Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded
Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.
AbbVie's 'Unjustified' Humira Settlements Divide Market, Class Action Claims
First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.
Fate Of JHL Biotech's Biosimilars Uncertain As Judge Bars Use Of Genentech Trade Secrets
Court denies JHL motion to dismiss trade secret theft suit, bars development or sale of biosimilars that rely on information from Genentech documents; trial scheduled to begin in November 2020.
Bill To Revise US Subject Matter Patent Eligibility Standard Expected By 'Early Summer'
Senators emphasize need for legislative reform at IP subcommittee hearing; ask USPTO director Iancu how a drug can have 130 patents, alluding to Humira.
Novartis Can't Halt Janssen's Promo Comparing Their Psoriasis Drugs
US judge is 'troubled' by Janssen's omission of relevant safety data in summary of Tremfya v. Cosentyx study, but finds Novartis claim of irreparable harm is 'too speculative.'