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

Trial Population Was One Reason For Pulling Surufatinib EU Filing

 
• By Neena Brizmohun

Hutchmed is in discussions with the European Medicines Agency on the path forward for its drug for advanced neuroendocrine tumors, whose marketing authorization application has now been withdrawn.

A path forward
Hutchmed is in discussions with EU and US regulators on the path forward • Source: Alamy

Hutchmed has withdrawn its EU marketing authorization application (MAA) for surufatinib, the company’s oral angio-immuno kinase inhibitor, which is approved as Sulanda in China for treating advanced neuroendocrine tumors but which the US regulator rejected in April this year.

The EU MAA was pulled after interactions between Hutchmed and reviewers at the European Medicines Agency suggested there was a...

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 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 
• By Jessica Merrill

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

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PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and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

More from Geography

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.

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
• By Michael McCaughan

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.