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AstraZeneca Faces Uphill Battle In Talking U.S. Docs Into Using Brilinta

 
• By Emily Hayes

U.S. physicians say skepticism over the North American results in the pivotal PLATO study is one of many factors that’s been slowing adoption. Competition with low-cost generics is another.

AstraZeneca PLC’s plan to turn around performance of Brilinta/Brilique (ticagrelor) in the U.S. is likely to be an uphill battle, considering competition from low cost clopidogrel generics and skepticism in the cardiology community about the North American results in the PLATO pivotal trial, among many other factors.

Approved in the U.S. in July 2011 and Europe in December 2010 for patients with acute coronary syndromes, the drug...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

EU Tests Unified Pathway For Combined Drug/IVD Studies

 
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The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
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Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

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• By Vibha Sharma

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