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BMS/Pfizer’s Eliquis On Priority Review Path Toward March 2012 Approval

 
• By Sue Sutter

Priority review designation for the Factor Xa inhibitor suggests FDA sees it as a major treatment advance over Pradaxa and Xarelto in reducing the risk of stroke among atrial fibrillation patients.

FDA’s priority review designation for Bristol-Myers Squibb Co./Pfizer Inc.’s Eliquis (apixaban) suggests the agency believes it offers a major treatment advance over two other recently approved anticoagulants – Pradaxa and Xarelto – in reducing the risk of stroke among atrial fibrillation patients.

BMS and Pfizer announced Nov. 29 that FDA has granted a six-month review for the Factor Xa inhibitor, setting a...

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Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

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EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
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The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

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Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

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• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

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• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.