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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.

Latest From Brenda Sandburg

Janssen’s COVID-19 Vaccine Should Continue To Be Available, CDC Panel Concurs

Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.

Advisory Committees Coronavirus COVID-19

J&J, Distributors May Be Free Of Opioid Litigation If Enough States Sign On To $26bn Settlement

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead. 

Legal Issues Advertising, Marketing & Sales

Statin Label Change May Signal Broader US FDA Shift On Drug Use During Pregnancy

Agency is removing warning contraindicating use of statins during pregnancy; the move comes after FDA has permitted COVID-19 vaccination of pregnant women and amidst push for their enrollment in clinical trials.

Drug Safety FDA

US FDA Is No Longer ‘Getting Crap’ From Sponsors In IND Safety Reports, Temple Says

FDA’s Robert Temple says he is gratified by the way companies have implemented the agency’s guidance on IND safety reporting. Merck, AbbVie and Janssen representatives discuss issues with unblinding data and the value of an aggregate analysis at DIA’s annual meeting.

Drug Safety Clinical Trials

Will COVID-19 Vaccine Booster Shot Restore Full Immunity? Wait For Answer Almost Over

ACIP will discuss possible boosters for immunocompromised people next week. Pfizer’s head of vaccine R&D and BioNTech co-founder and CEO discuss whether neutralizing antibodies are necessary for protection against SARS-CoV-2, indication in children, and the low and high points of their collaboration at Stat summit.

Coronavirus COVID-19 Vaccines

Amgen’s Neulasta Ad Indirectly Targeting Biosimilars Draws US FDA Rebuke

Animated banner ad claiming administration of Neulasta with Amgen’s Onpro on-body injector has less risk of febrile neutropenia than administration via prefilled syringe draws untitled letter and a rare press release. FDA says claims could undermine confidence in biosimilar pegfilgrastim products.

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