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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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Expedited Reviews For China-Originated Drugs Shift Back Home

 
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The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

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PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
• By Eliza Slawther

PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.

More from Pink Sheet

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• By Michael McCaughan

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PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
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Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

 
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Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.