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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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Contrave Rxs Jump In Q1, But TV Commercial Runs Afoul Of FDA

Orexigen touts 39% growth in US sales of its obesity drug; agency objects to advertisement for excluding risk information.

FDA Advertising, Marketing & Sales

Contrave TV Ad's Slimmed Down Adverse Events Draw FDA Rebuke

Referencing opioids and suicidal thoughts is not sufficient, US regulators say; letter comes as Orexigen has seen an upsurge in Contrave prescriptions.

Advertising, Marketing & Sales Regulation

Trump's Medicaid Funding Change Could Alter Drug Access, Rebates

Budget proposal to fund state Medicaid programs through per capita cap or block grant would save $610bn over 10 years, administration says; budget calls for clarifying treatment of value-based pricing and fostering exchange of pre-approval information between manufacturers and payers.

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Biopharma Patent Disputes: Upheaval Likely As US Supreme Court Limits Litigation Venue

Decision requiring suits to be filed in state where defendant is incorporated may deter consolidation of ANDA suits and increase venue fights; Court to hear challenge to PTAB inter partes review process.

Intellectual Property BioPharmaceutical

Biosimilar Litigation: Janssen Vs. Samsung Anticipates Supreme Court Decision

Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.

Biosimilars Legal Issues

Coherus Knocks Out One Humira Patent But Others Block Biosimilars

Patent Trial and Appeal Board invalidates patent on method to treat rheumatoid arthritis; next hurdle is overcoming formulation patents that do not expire until 2022.

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