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Robert Barrie on Muck Rack

Robert Barrie

Verified
London
As seen in: Clinical Trials Arena, GlobalData, Medical Device Network, MSN, Yahoo Finance, New Scientist, Yahoo, EIN News, NewsBreak, Pharmaceutical-Technology.com, Yahoo Finanzas, Just-Drinks, Just-Food and
Healthcare reporter at GlobalData
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Articles

FDA AdCom shuns Capricor’s DMD cell therapy amid data dispute

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By Robert Barrie Verified
| Pharmaceutical-Technology.com Verified
Capricor is adamant its Phase III study showed effectiveness, though panel members called data “fragile”. Committee members voted 9-3 against recommending approval of Capricor’s deramiocel. Credit: Andrii Yalanskyi/Shutterstock.com.
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FDA AdCom shuns Capricor’s DMD cell therapy amid data dispute

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By Robert Barrie Verified
| Yahoo Verified
A US Food and Drug Administration (FDA) advisory committee meeting (AdCom) has voted against Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy (DMD), capping an extraordinary meeting in which the agency and biotech fundamentally disagreed on how key study data was analysed. In a meeting which saw a buildup dominated by disagreements over the FDA's briefing document, committee members voted 9-3 against recommending approval of Capricor's deramiocel.
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AdCom expected for uniQure’s Huntington’s gene therapy, chief medical officer says

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By Robert Barrie Verified
| Pharmaceutical-Technology.com Verified
If approved, uniQure’s AMT-130 would be the first disease-modifying treatment for the inherited neurodegenerative disorder. Approximately 75,000 people in the US, Europe, and the UK have the inherited disease, which is fatal within 15 to 20 years of symptom onset. Credit: ahmetmapush/Shutterstock.com.
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