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Pfizer paying out millions, again, to settle off-label promotion charges in the US

 
• By Donna Young

Once again, US pharma giant Pfizer is having to pay out millions of dollars to the US federal government and states to settle charges of illegal promotion of the company's medicines, with the latest settlements totaling about $98 million1. While a far cry from the $2.3 billion the New York drug maker paid under a 2009 guilty plea for promoting its cyclooxygenase-2-selective nonsteroidal anti-inflammatory drug Bextra (valdecoxib), this is still a tidy sum of cash2.

Once again, US pharma giant Pfizer is having to pay out millions of dollars to the US federal government and states to settle charges of illegal promotion of the company's medicines, with the latest settlements totaling about $98 million1. While a far cry from the $2.3 billion the New York drug maker paid under a 2009 guilty plea for promoting its cyclooxygenase-2-selective nonsteroidal anti-inflammatory drug Bextra (valdecoxib), this is still a tidy sum of cash2.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 
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FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.