In Case You Missed In It: News On FDA’s Foreign Offices, Decentralized Clinical Trials, And More

We clean out your MLK Day inbox so you don’t have to.

While our US staff used the Martin Luther King, Jr. holiday to relax, reflect, and give back to our community, the Pink Sheet’s global team continued to deliver insights about the pharmaceutical industry. Below are the stories that went out in the Monday email in case you missed them:

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

 

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

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

 

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.