1. Pink Sheet
  2. >>Geography
  3. >>Europe

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 
• By Eliza Slawther

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.

UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

 
• By Neena Brizmohun

A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.

Plans For EU Biotech Act Shift Up A Gear

 
• By Eliza Slawther

Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.

More from Geography

UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

 
• By Neena Brizmohun

A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

Pharma Cooperating With Trump On Direct Sale To Consumers, Pfizer CEO Says

 
• By Jessica Merrill

Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Albert Bourla said.