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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 Puts Spotlight On Alkermes' Violative Vivitrol Ad

The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.

Advertising, Marketing & Sales Ad Complaints

Biologic Exclusivity Provision In USMCA Is Boon To Generics Industry; BIO Is 'Tremendously Worried'

Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.

Trade Intellectual Property

US FDA's Pediatric Experts, Not Review Division, Should Have Final Say On Pediatric Trials, Former Official Says

Former Associate Commissioner Janice Soreth says views of pediatric experts should take precedence over those of division directors regarding pediatric trials.

FDA Pediatrics

US FDA's Office Of New Drug Leaders Listen To Stakeholders

Twenty-five officials of FDA's Office of New Drugs gather to hear recommendations from stakeholders on what they can do to improve drug development programs.
FDA Drug Review

US Supreme Court Seems Poised To Allow Patent Holders More Judicial Review Options

In case that could impact challenges of biopharma patents, Supreme Court questioned the consequences of not allowing courts to review PTAB institution decisions when petition may be time barred.

Intellectual Property Legal Issues

Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation

Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.
Generic Drugs Legal Issues
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