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ASH Data Drive Momentum For Revolution In CLL Treatment

 
• By Emily Hayes

American Society of Hematology meeting provided a platform for J&J/AbbVie’s Imbruvica to continue on its strong upward trajectory and for AbbVie/Roche’s newcomer venetoclax to shine, while Gilead’s flagging Zydelig demonstrated mixed results.

Johnson & Johnson/AbbVie Inc.’s Imbruvica has emerged on top once again in the transitioning chronic lymphocytic leukemia market, leaving Gilead Sciences Inc.’s already flagging Zydelig to struggle with some new safety issues, but Roche/AbbVie Inc.’s investigational BCL-2 inhibitor venetoclax looks to be a strong contender.

This year’s American Society of Hematology annual meeting, held Dec. 5-8 in Orlando, Fla., provided a platform for established CLL drugs to expand and new drugs to make their mark.

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Canada Cuts Red Tape With Single Ethics Review For Trials

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EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

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UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.