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

EMA's New PRIME Scheme Gets 18 Applications In First Month

 
• By Neena Brizmohun

Eleven applications to the European priority review program came from smaller companies.

The European Medicines Agency says it has received 18 applications for entry in its much-talked about PRIME (priority medicines) scheme since launching the initiative only one month ago1.

The announcement, which the EMA made via Twitter* on April 7, follows the agency's prediction that it would be "flooded...

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

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PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and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

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

 
• By Francesca Bruce

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.

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

More from Geography

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By Sue Sutter

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.