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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 Federal Courts Can Operate Until Jan. 25; Patent Office Faces Eminent Closure Under Shutdown

Federal courts and USPTO will soon run out of funds that have allowed them to continue normal operations; pending ANDAs to get same filing date, which could lead to FDA legal challenges.
Legal Issues Intellectual Property

Bristol-Celgene: Congressional Reps Want Assurance Merger Will Not Increase Prices

Reps. Welch and Rooney urge FTC and DOJ to condition their approval of the merger on inclusion of a pricing provision.

Pricing Debate M & A

Co-Pay Vouchers May Not Be Enough To Boost Patient Adherence To Blood Thinners

Acute MI patients who received voucher had 3.3% increase in persistence with clopidogrel or ticagrelor, but no significant reduction in major adverse cardiovascular events, ARTEMIS study finds.

Policy Cardiovascular

Dartmouth Researchers Call For FDA To Expand Regulation Of Rx Drug Marketing

In JAMA report, researchers document the evolution of drug advertising, suggest FDA monitor detailing and establish standards for disease awareness campaigns.

Advertising, Marketing & Sales Regulation

US FDA Advertising Citations Remain Rare In 2018

With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.

Advertising, Marketing & Sales Enforcement

US High Court Won’t Hear FCA, Patent Cases

The US Supreme Court announced Monday that it won’t hear a much-watched case that could have limited the government’s ability to bring False Claims Act cases if it knew of the alleged misconduct. Two drug-world patent cases were also declined.

Legal Issues Intellectual Property
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