Jumping Before They Were Pushed – Kiadis And Aradigm Withdraw EU Filings

A Third Company, Actelion, Has Pulled An Indication Extension Request

Notice of the withdrawal of pan-EU marketing authorizations applications by Kiadis Pharma and Aradigm are noted in the agenda of the latest meeting of the European Medicines Agency's key scientific committee, the CHMP. 

Seesaw
The CHMP was planning to reject two applications • Source: Shutterstock

Two companies – Kiadis Pharma and Aradigm – have formally withdrawn pan-EU marketing authorization applications (MAAs) after they were told these were likely to be rejected. A third company, Actelion, has withdrawn an application to extend an indication of an already marketed product. 

The MAAs relate to Kiadis Pharma’s lead product and stem cell transplant adjunct, ATIR101, and

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

More from Product Reviews

More from Pink Sheet

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By 

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By 

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.