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Sarepta Will Challenge Expected No From EMA On Exondys 51

 
• By Sten Stovall

Sarepta is expecting the European Medicines Agency to recommend against EU approval of its Duchenne muscular dystrophy treatment eteplirsen. Persuading the agency to change its mind during the appeal will be an uphill task for the company.

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Sarepta’s DMD Drug Eteplirsen Has Been Rebuffed by European Regulators • Source: Shutterstock

Sarepta Therapeutics Inc. is planning to appeal the expected knock-back of its EU marketing authorization application (MAA) for the controversial drug eteplirsen.

A negative opinion on the MAA from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is...

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Recent And Upcoming FDA Advisory Committee Meetings

 
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The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

ACIP ‘Pivot’ May Mean Variable US Coverage For New Vaccines, Higher Copays

 
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CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

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