Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Set Alert for Articles By Brenda Sandburg

Latest From Brenda Sandburg

Biosimilar Sponsors Are Not Liable Under State Law For Declining Patent Dance

US Federal Circuit finds in Amgen v. Sandoz that the BPCIA preempts innovator companies from seeking penalties under state law against a biosimilar sponsor that does not engage in the 'patent dance.'

BioPharmaceutical Policy

Sanofi's Dengue Vaccine Gets WHO Backing In People Previously Infected

Label restriction, discussions with regulators should keep vaccine in use, Sanofi suggests; Philippines suspended its vaccination program after data showed product can worsen disease in those not previously exposed to infection.

BioPharmaceutical Policy

PhRMA Sues To Block 'Unprecedented' California Price Reporting Law

Ban on WAC price increases violates Commerce Clause and reporting requirement violates First Amendment, PhRMA contends; complaint says state officials have not clarified whether law is retroactive.

BioPharmaceutical Policy

Identifying Deceptive Rx Advertising: FDA Rejects PhRMA's Criticisms Of Its Study

US agency disagrees that study of consumer and healthcare professional ability to detect deceptive promos is unnecessary; final guidance on product name placement in labeling and advertisements mirrors 2013 draft.

Advertising, Marketing & Sales Regulation

Drug Sponsors Mostly 'On Track' With Postmarket Study Requirements

US FDA's annual report on the status of postmarketing requirements and commitments shows 84% of open postmarket requirements for NDAs and 91% for BLAs were progressing on schedule as of Sept. 30, 2016; about half have not yet begun.

BioPharmaceutical Regulation

How To Conduct A Multi-Company Trial For Rare Pediatric Diseases

US FDA draft guidance suggests efficacy endpoints for testing multiple drug products in the same clinical trials; advances an FDA-EMA joint proposal promoting innovative approaches for development of Gaucher disease medicines.

Rare Diseases Pediatrics
See All
Advertisement
UsernamePublicRestriction

Register