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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

Rejecting PhRMA's Request, US FDA Sticks With Size Over Function In Defining Biologic

Agency's final rule defines protein based on size of amino acid sequence, irrespective of method of manufacture, saying this 'bright-line rule' provides regulatory certainty.

Biologics FDA

Two Companies, Two BARDA Contracts, Two Approaches To Coronavirus

Sanofi follows Janssen in teaming up with HHS' BARDA to develop a COVID-19 vaccine; using technology platform of its Flublok vaccine, Sanofi expects to enter clinical trials in 1 to 1 ½ years.

Vaccines Infectious Diseases

Sanofi Tries To Stop Lantus Biosimilar By Getting Supreme Court To Review PTAB, Again

Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.

Legal Issues Intellectual Property

Sanofi Improperly Listed Lantus Patent In FDA's Orange Book, Appeals Court Finds

First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district court to decide if this constitutes antitrust violation.

Legal Issues Intellectual Property

FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims

Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).

FDA Legal Issues

Pharma Enforcement Remains 'Priority Area' In FTC's 2021 Budget Request

US Federal Trade Commission has mainly focused in pay-for-delay cases over the past decade, but pricing strategies are an emerging area of attention; industry is paying close attention to potential enforcement in biosimilar market.

Enforcement Legal Issues
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