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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 Scientists Give Leadership High Marks; Some Worry About Industry Influence

Union of Concerned Scientists' survey finds 65% of 354 respondents feel their direct supervisors back them on politically contentious positions; Commissioner Gottlieb gets glowing reviews.

FDA BioPharmaceutical

Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product

Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

BioPharmaceutical Regulation

Genentech Wins Attorneys' Fees After Phigenix's Aggressive Patent Suit

"Tipping point" occurred when Phigenix changed theory that Genentech's Kadcyla infringed its patent; CEO may be on hook for attorneys' fees.

Legal Issues Intellectual Property

PhRMA Criticizes 'Exponential Pace' Of FDA Rx Drug Advertising Studies

US FDA responds to comments on proposed study of product disclosures and study of amount and location of risk information.

Advertising, Marketing & Sales Regulation

Biosimilar Litigation Trends: Settlements, Declaratory Judgment Rejections, Congressional Intervention

Of the 27 suits brought so far, four have resulted in patent settlements; restarting patent dance is new trend for ongoing litigation.

Biosimilars Intellectual Property

Legality Of J&J's Remicade Contracting Depends On Share Of Biosimilar Market Foreclosed, Court Rules

Court denies J&J's motion to dismiss Pfizer's antitrust suit, saying discovery will reveal whether Pfizer has offered more competitive pricing for its Inflectra biosimilar and if there are alternative causes for Pfizer's inability to gain market share.

BioPharmaceutical Policy
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