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GTx Muscle Wasting Drug Fails, But Data Offer Possible New Path

 
• By Shirley Haley

Enobosarm failed under FDA analysis plan but met European requirements in NSCLC muscle wasting trials, while a potential survival signal may lead to a positive change of plans in the U.S.

GTx Inc. may try to recharacterize its muscle wasting drug enobosarm after top-line data from a pair of Phase III trials linked the nonsteroidal selective androgen receptor modulator (SARM) with a potential positive impact on survival, Mitchell Steiner, chairman and CEO, said during an Aug. 19 call with analysts.

In top-line data from the POWER1 and POWER2 trials, enobosarm, which the company plans to market as Ostarine, failed to meet the co-primary endpoints of improved lean body mass and...

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Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

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.