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Nexium OTC Switch Would Face Crowded Field, Potential Questions

 
• By Malcolm Spicer

Pfizer will pay AstraZeneca $250 million upfront for global rights to market a potential OTC 20-mg Nexium. Pharma marketing expert Joe McGovern expects Nexium “to start OTC with a big bang,” but Center for Consumer Self Care Executive Director Bill Soller points to potential safety questions about a switch.

A crowded proton pump inhibitor market awaits Pfizer Inc.after acquiring rights to an OTC Nexium, but a switch of the esomeprazole magnesium product could encounter safety questions even with similar molecules already available nonprescription for frequent heartburn.

Pfizer will make an upfront payment of $250 million to AstraZeneca PLC for global rights to market a potential...

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More from Europe

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

Denmark: QALY Brings HTA Transparency But Industry Wants More Willingness To Value Innovation

 
• By Francesca Bruce

Rare disease drugs with limited evidence are most likely to be awarded a negative reimbursement recommendation in Denmark following a QALY-based health technology assessment, finds an analysis from industry group LIF.

AI’s Attempt To Decode EU Pharma Reform Called A ‘Car Crash’

 
• By Eliza Slawther

Sanofi’s EU regulatory science and policy head draws on a “nightmare” experience with using a generative AI tool to compare versions of the draft EU pharma reform text to explain the benefits and limitations of artificial intelligence tools in regulatory affairs.

More from Geography

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.