FTC Review Of Express Scripts/Medco Merger Is First Integration Challenge

The proposed merger of two of the three major pharmacy benefit managers may have tough time clearing FTC; the agency has rejected other deals that would have left only two dominant players in a sector.

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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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EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

 

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.