The Return Of The Blockbuster? Stage Is Set For Prasugrel Approval

FDA's handling of the advisory committee meeting for Lilly/Daiichi Sankyo's platelet inhibitor prasugrel is the first signal in some time that the agency is ready to approve a primary care drug to be used in large patient populations with relatively limited restrictions

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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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Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 

A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.