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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

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

Innovative Trial Designs Are 'Life And Death Matter' For Pharma, Amgen Tells US FDA

Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.

Clinical Trials FDA

Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation With DOJ

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

Glumetza Patent Settlement Without An Authorized Generic Plus Price Hike Spawns Litigation

Walgreen and other retailers allege no-authorized generic patent settlement for extended-release metformin allowed Santarus (Valeant) to block generic entry for four years while raising the price more than 750%.

Legal Issues Intellectual Property

Genomics Data Should Get More Attention In FDA Drug Review And Labeling, Regeneron Says

Regeneron advocates industry-FDA collaboration to establish regulatory standards for novel applications of genomic data, such as determining whether long-term outcomes studies are needed, and inclusion of the data in product labeling.

Drug Approval Standards Drug Review

Adaptive Clinical Trials: US FDA Offers More Advice On Bayesian Designs

Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.

Guidance Documents Clinical Trials
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