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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

Payers Could Guarantee Biosimilar Market Share, FDA's Gottlieb Suggests

Commissioner worries that fewer drugs may enter market in some categories because of drug development costs, and offers some post-market strategies for encouraging biosimilar development.

Biosimilars Pricing Debate

Opioid Industry's 'Superstructure' Targeted By State Attorneys General

Janssen, Teva, Allergan, Endo, and Purdue – as well as several distributors – pursued in multistate investigation that follows individual AG inquiries and flurry of state, city, and county suits.

Legal Issues Advertising, Marketing & Sales

US FDA May Change Opioid Labeling To Limit Dispensing By Indication

Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication; Patrick Kennedy is calling on CMS to provide reimbursement for opioid addiction treatment.

Risk Management Private Payers

GSK's Shingrix Shingles Vaccine Awaiting Final Labeling Tweaks

US advisory committee unanimously impressed by the 90% plus efficacy; FDA says label may note lack of data in those who've previously had shingles.

Advisory Committees Vaccines

Shingrix Shingles Vaccine: FDA Wants GSK To Monitor Inflammation Risk

GlaxoSmithKline's vaccine has 97.16% efficacy, surpassing Merck's Zostavax, but US advisory committee will weigh risks from inflammation which could cause ocular adverse effects and gout.

BioPharmaceutical Regulation

Warning Label For Gadolinium Contrast Agents Gets US FDA Panel Backing

Advisory committee agrees that risks of gadolinium retention in the brain and other organs need further study; actor Chuck Norris' wife was among several patients who testified of devastating medical problems following administration of agents.

BioPharmaceutical Advisory Committees
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