Brenda Sandburg
Senior Editor

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.
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.
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.
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.
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.
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.