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EU Fast-Track Success For BioMarin’s Valrox But Not For Amarin’s Vascepa

Filings For Both Products Are Due By Year End

 
• By Maureen Kenny

Just one of four accelerated assessment requests that were decided on at the European Medicines Agency this month is known to have been granted – for BioMarin’s Valrox. There was rejection for Amarin; Roche and Orchard are keeping the outcomes to themselves.

Race_Track_Stopwatch
The EMA is to review BioMarin's planned marketing application more quickly • Source: Shutterstock

BioMarin’s potential new gene therapy for severe hemophilia A, Valrox (valoctocogene roxaparvovec), will be fast tracked through the system when the company files for pan-EU approval later this year.

The European Medicines Agency’s key scientific committee, the CHMP, granted BioMarin’s request for accelerated assessment of the company’s planned marketing authorization application (MAA) for Valrox at

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England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
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• By Francesca Bruce

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

More from Geography

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.