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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

Pfizer Ex-Marketing Director Agrees To Injunction, Ending Trade Secret Suit

Former Pfizer employee has joined Sun Pharma as it launches ophthalmic drug and expands its specialty portfolio, which includes Phase III monoclonal antibody for treatment of psoriasis.

BioPharmaceutical Policy

Advair Generic Approval Uncertain Despite US FDA Denial Of Sandoz Petition

Agency declined to say whether ANDA sponsors would need to meet requirements requested by Sandoz; Mylan's generic user fee date is March 28.

Generic Drugs FDA

Biopharma Asks US Supreme Court Not To Limit Patent Litigation Venue

Innovators say case before court could upend ANDA litigation by preventing consolidation of cases; Genentech sees potential impact on biosimilar suits.

Legal Issues Intellectual Property

Newron's Parkinson's Disease Drug Xadago Priced At $600-700/Month

First new chemical entity for Parkinson's to clear FDA in 10 years, Xadago has a narrower indication than Teva's Azilect and similar pricing.

Approvals Regulation

Newron's Parkinson's Drug Xadago Has Narrower Indication Than Teva's Azilect

After overcoming regulatory hurdles, Newron may have tough time competing in US against market stalwart Azilect; eight Parkinson's drugs are in Phase III trials.

Approvals Regulation

Pharma Patents Are Vulnerable In Canada As Lilly Loses NAFTA Challenge

Tribunal finds Lilly did not prove that Canada's promise utility doctrine discriminates against pharmaceutical patents; 25 pharma patents have been invalidated in past decade.

Intellectual Property Legal Issues
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