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EU explains criteria for issuing duplicate marketing authorisations

 
• By Vibha Sharma

Pharmaceutical companies seeking duplicate/multiple marketing authorisations for drugs approved under the European centralised procedure can now refer to a new document issued by the European Commission that explains the criteria applied for granting such authorisations1,2.

Pharmaceutical companies seeking duplicate/multiple marketing authorisations for drugs approved under the European centralised procedure can now refer to a new document issued by the European Commission that explains the criteria applied for granting such authorisations1,2.

The document, the commission says, has been issued in response to a steady increase in the number of requests for...

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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.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

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

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Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
• By Cathy Kelly

The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.