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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

NIH Eyes Expansion Of US FDA Partnerships To Gene Therapy

NIH Director Francis Collins describes evolution of existing collaborations and how the two agencies might facilitate development of gene therapy, such as by having a common template for regulatory review.

FDA Gene Therapy

DOJ Casting Wider Net In Pharma Kickback Probes

Government is pursuing behavior it once would have taken a pass on, former DOJ attorney notes; pharma companies have inked 16 settlements in past year.

 
Advertising, Marketing & Sales Enforcement

California's Pay-For-Delay Law May Be Harsher Than FTC Regulation, Could Face Legal Challenge

Governor Newsom signs bill that presumes brand-generic patent settlements are anticompetitive; AAM says the law violates US Constitution by attempting to regulate transactions outside the state.

Legislation Intellectual Property

Supreme Court Seems Unconvinced USPTO Should Receive Attorneys' Fees In District Court Litigation

Justices question why it took 170 years for the patent office to seek attorneys' fees from patent applicants who challenge its decisions in district court; USPTO acknowledges the delay is 'atmospherically unhelpful.'

Legal Issues Intellectual Property

Pain, Biomarkers And Precision Medicine: Insurance Coverage Is One Ethical Challenge

There are "tremendous concerns" about potential abuse of biomarkers to diagnose pain, Stanford University researcher tells FDA Science Forum.

Personalized Medicine Clinical Trials

J&J Settlement Leaves Teva As Sole Opioid Maker In Bellwether Trial

Four distributors and Walgreens also remain defendants; court to consider Teva's motion to dismiss if the trial results in a judgement against its subsidiaries. Seven-week trial could include 215 witnesses and 21,000 exhibits.

Legal Issues Advertising, Marketing & Sales
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