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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

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.'

Legal Issues Advertising, Marketing & Sales

Purdue Puts Forth FDA Decisions As Defense To Massachusetts Opioid Suit

Purdue says Commonwealth is trying to hold it liable for conduct FDA has authorized; citing agency's approval of long-term use of OxyContin for chronic pain, company asks court to dismiss complaint.

Legal Issues Neurology

Legal News: Teva V. FDA, Pay-For-Delay, Citizen Petitions, User Fee Scheme

US court tosses Teva suit seeking generic Restasis exclusivity. FTC loses appeal challenging Shire's citizen petitions, settles Solvay pay-for-delay case. DoJ resolves FCA case alleging company made deal to avoid paying FDA user fees for two NDAs.

Legal Issues Intellectual Property

HHS' 2018 Greatest Hits: Azar Touts Record FDA Generic Approvals, Drug Pricing And Opioid Actions

In State of the Department speech and HHS annual report, Secretary Azar trumpets historic number of approvals by FDA, and price cuts, roll backs or freezes by 'more than a dozen drug companies.'

Pricing Debate FDA
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