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Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.
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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.

FDA Biosimilars

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.

FDA Legal Issues

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.

BioPharmaceutical Biosimilars

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.

Intellectual Property Biosimilars

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.

Intellectual Property Legislation

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.'

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