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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

Pink Sheet Podcast: Another Coronavirus Stimulus Bill, Remdesivir’s Brief Orphan Status, Teva Sues Over Copaxone Regulation

Pink Sheet editor and reporters discuss the effects of the latest coronavirus stimulus package on pharma, Gilead’s request for rescission of an orphan designation, and Teva’s suit over Copaxone regulation. 

Coronavirus COVID-19 Legislation

Teva Sues FDA For Excluding Copaxone From BLA Transition

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

Legal Issues Biosimilars

Teva Sues FDA For Excluding Copaxone From BLA Transition; Wants To Use Biosimilar Litigation Process

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

Biosimilars Legal Issues

Gilead's Request To Revoke Remdesivir Orphan Designation Reflects Pandemic Pressures

Two days after US FDA granted remdesivir orphan status for treatment of COVID-19, Gilead told the agency it is unnecessary. EMA says it would not grant orphan drug designation to a COVID-19 treatment.

Coronavirus COVID-19 Rare Diseases

Orphan Drug Designation For Remdesivir Is 'Consistent' With Precedent, Former FDA Lawyer Says

Attorney who drafted Orphan Drug Act implementing regs says companies need incentive to develop a treatment that may not be available until crisis passes; KEI is mulling citizen petition to request revocation of the designation for Gilead's investigational COVID-19 product.

Coronavirus COVID-19 FDA

New Patent Litigation Playbook For Products Switching To Biologics

Innovators are losing the protections of ANDA litigation as their products transition from drugs to biologics; both sides in patent disputes will now adopt different strategies.

Biologics Biosimilars
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