1. Pink Sheet
  2. >>Geography
  3. >>Europe

Pfizer’s Bosulif Too Expensive And Lacks Data, Says NICE

 
• By Faraz Kermani

NICE has rejected Bosulif for leukemia principally on cost grounds, but also due to a lack of comprehensive long-term data, which is also being sought by the EMA.

Pfizer Inc. is either going to have to come up with the additional information required by the European Medicines Agency for its myeloid leukemia therapy Bosulif (bosutinib) marketing authorization, or cut the drug’s price by a third if it is going to satisfy the U.K. reimbursement watchdog, NICE.

Bosulif has a “conditional” central marketing authorization from the EMA for the treatment of Philadelphia chromosome-positive chronic, accelerated or blast...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

England Prioritizes SGLT-2s & GLP-1s In Diabetes Market Access ‘Shake Up’

 
• By Neena Brizmohun

Recommendations from the health technology assessment institute, NICE, reflect a strategic shift from treating type 2 diabetes to proactively preventing future complications of the condition.

UK Tests Risk-Proportionate Review Of Substantial Clinical Trial Amendments

 
• By Vibha Sharma

Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

More from Geography