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Pfizer Reorganizes Internally As It Moves Closer To Decision On Splitting Business

 
• By Wendy Diller

Beginning in January 2014, Pfizer is realigning its commercial operations into three organizations, in effect taking the next step on its multi-year deliberation over whether to split up its behemoth business.

Pfizer Inc. is reorganizing its commercial operations into three business segments, and has named top executives to run them, broadly in line with plans it has outlined in discussions over the past two years with Wall Street analysts.

As of Jan. 1, 2014 in much of the world, it is forming two businesses focusing on innovative products and...

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New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the European Medicines Agency to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor

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.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

New South Korea Health Minister Vows ‘People-Centric’ Medical System

 
• By Jung Won Shin

In line with new President Lee’s campaign pledges, South Korea's newly confirmed health minister is expected to tackle key issues including a prolonged doctors' conflict, essential drug supplies and R&D support for the industry.

More from Pink Sheet

New South Korea Health Minister Vows ‘People-Centric’ Medical System

 
• By Jung Won Shin

In line with new President Lee’s campaign pledges, South Korea's newly confirmed health minister is expected to tackle key issues including a prolonged doctors' conflict, essential drug supplies and R&D support for the industry.

Vinay Prasad Out At US FDA

 
• By Sarah Karlin-Smith

The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.

Merck, AstraZeneca Downplay Impact of European Tariffs Despite Timing Uncertainties

 
• By Cathy Kelly

Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.