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Santhera Setback Could Have Wide-Reaching Effects For DMD Drugs

 
• By Lisa LaMotta

The DMD community faces another setback as FDA pushes back timelines for Santhera and its respiratory drug, pushing the market to question what will come for other DMD treatments in development.

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In an unsurprising move, FDA has asked Santhera Pharmaceuticals AG for further data before it considers the company's Duchenne muscular dystrophy (DMD) drug for approval. While in-line with typical FDA approval protocol, the decision could have wide-ranging implications for the other companies in the space and ultimately Santhera's command of the market.

The Swiss biotech announced July 14 that the US regulatory agency has said the Phase III DELOS trial will not...

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