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Brenda Sandburg

Senior Editor

New York, NY
Brenda covers FDA regulatory policy and legal issues, including patent suits, Supreme Court cases, and government investigations, as well as developments at the US Patent and Trademark Office and Federal Trade Commission. Between stints at the Pink Sheet, she was a reporter for America Lawyer Magazine and a daily legal newspaper in San Francisco where she won several awards, including first place in investigative reporting for an article about the emergence of patent trolls. She is based in New York City.

Latest From Brenda Sandburg

DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure

Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.

Enforcement Compliance

What Would US FDA Do If Supreme Court Eliminates Or Curtails Chevron Deference?

Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.

Politics Legal Issues

What Will FDA Do If Supreme Court Curtails Chevron Deference?

Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.

Legal Issues FDA

FTC Expands PBM Probe To Group Purchasing Organizations

Commission issues compulsory orders for information to two organizations that negotiate drug rebates on behalf of CVS Caremark, Express Scripts and other PBMs. It issued similar orders to the six largest PBMs last year.

Reimbursement Pricing Debate

Supreme Court Finds Amgen’s PCSK9 Patent Claims Go Beyond What It Invented

In unanimous decision, court finds Amgen patent offered persons skilled in the art “little more than advice to engage in ‘trial and error.’” Lawyers say the ruling prevents function claims from monopolizing a therapeutic target and retains status quo on enablement requirement.

Intellectual Property Biologics

FTC Targets Amgen Bundling And Rebates In Suit To Block Horizon Acquisition

Complaint marks first time agency has raised novel theories of competitive harm in pharma merger and is rare instance in which it has filed a complaint without a consent decree. Last time FTC has gone to court to block a pharma merger was in 2008.

Legal Issues M & A
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