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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

Advances On the Biosimilar Litigation Battlefield

A look at the evolution of litigation, from Amgen's 'bold' at-risk launch of Herceptin and Avastin biosimilars to the jump in settlements, new battles over manufacturing information and an expected petition to the Supreme Court.

Biosimilars Intellectual Property

Amgen Could Block Enbrel Biosimilars For Another Decade As Court Rules Stealth Patents Valid

Court rejects Sandoz's arguments that patents covering Enbrel's active ingredient and method of manufacture are invalid; decision comes three years after FDA approved Sandoz's biosimilar.

Biosimilars Intellectual Property

Opioid Blister Packs Need Study Before Mandate, Groups Urge

AAM, Upsher-Smith, APhA, and Cigna tell US FDA that packaging requirement will increase manufacturing and drug costs, create reimbursement hurdles and reduce access to medicines. Daiichi-Sankyo supports agency's proposal.

Drug Safety Neurology

How Can US FDA Bolster Drug Development? The Agency Wants Your Advice

Public meeting scheduled for November to seek recommendations for policies that FDA could implement short-term to promote drug development programs.

FDA Clinical Trials

US FDA's Rush Following Novartis' Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation

Early release of inspection findings is unusual, signaling likelihood that Novartis will face tough scrutiny of its actions, and perhaps stiff fines because of the fraud.

Legal Issues Gene Therapy

Patent Fees Increasing, Driven By Fewer Filings, Jump In PTAB Workload

US Patent and Trademark Office proposes 5% across the board patent fee adjustment plus targeted fee hikes; Patent Trial and Appeal Board costs have risen following Supreme Court's SAS Institute decision.

Intellectual Property Legal Issues
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