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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

With 5-0 Winning Streak, Bayer And J&J Move To Eliminate Remaining Xarelto Litigation

Firms want Fifth Circuit to review whether federal law preempts failure-to-warn and design-defect claims; ruling in their favor could end 20,000-plus pending US cases.

Legal Issues Policy

Does AbbVie Have 'Unclean Hands' From Building Humira Patent Thicket? Judge Allows Discovery

Magistrate judge says Boehringer's theory 'may or may not be viable' as an infringement defense; permits third party subpoenas for information on clinical trials.

Biosimilars Intellectual Property

Eagle Will Be Last Firm To Bypass FDA's Orphan Drug Exclusivity Requirement

Court orders US FDA to award Bendeka seven years of exclusivity without requiring clinical superiority test; law codifying FDA policy passed prior to suit and is not retroactive.

Legal Issues Regulation

Dr. Reddy's Launches First Generic Suboxone Film; Indivior May Seek Injunction

Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.

Generic Drugs Approvals

Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices

Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.

Biosimilars State News

'Off-Label' Communications That Are Still 'Consistent' With Labeling Get Better Defined

US FDA's final guidance provides more examples of data that meets the 'scientifically appropriate and statistically sound' standard.

BioPharmaceutical Regulation
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