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Zinbryta Global Withdrawal Driven In Part By Difficulty Of Safety Assessment

 
• By Nielsen Hobbs

EMA safety investigation pushes decision as AbbVie, Biogen acknowledge 'characterizing the evolving benefit/risk profile … will not be possible going forward given the limited number of patients being treated.'

Vintage looking Withdrawn stamp on a book page

The withdrawal of the multiple sclerosis drug Zinbryta (daclizumab) from worldwide marketing by Biogen Inc. and US marketing partner AbbVie Inc. underscores how difficult safety can be to assess, even in limited patient populations.

Biogen and AbbVie announced the decision to withdraw Zinbryta on March 2 as the European Medicines Agency announced that it...

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• By Vibha Sharma

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 
• By Anabel Costa-Ferreira

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.

England’s NICE Hunts For New Chief As Sam Roberts Prepares To Step Down

 
• By Eliza Slawther

Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.

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• By Nielsen Hobbs and Derrick Gingery

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