EMA PRIME Scheme: Two New Entries, 10 Rejections & One Withdrawal

 

A total of 141 products have made it onto the European Medicines Agency’s PRIME (priority medicines) scheme since 2016 and over 370 applications have been denied entry.

EU Biosimilar Filings, Opinions And Approvals

 

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.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU Biosimilar Filings, Opinions And Approvals

 
• By 

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.


EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

New EU Filings

 

Pridopidine, Prilenia Therapeutics’ investigational treatment for Huntington’s disease, is among the latest products that the European Medicines Agency has started reviewing for potential pan-EU marketing authorization.

EU Filings

New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.


EU CHMP Opinions And MAA Updates

Recommendations by the European Medicines Agency’s human medicines committee (the CHMP) on the authorization of new medicines in the EU and updates on marketing authorization changes recommended by the CHMP. Updated monthly.

EU Approvals

Products containing new active substances that have been approved for marketing in the EU under the EU’s centralized authorization procedure. Updated monthly.

EU Accelerated Assessment Tracker

Decisions on sponsor requests for accelerated assessment of planned EU marketing authorization applications that will be reviewed by the European Medicines Agency’s human medicines committee (the CHMP) as well as information on whether MAAs granted accelerated assessment retain fast-track status as they make their way through the EU centralized procedure. Updated monthly.

EU Biosimilar Filings, Opinions & Approvals

New biosimilar product filings for review by the European Medicines Agency’s human medicines committee (the CHMP), CHMP opinions, withdrawals of applications and decisions on biosimilar marketing authorizations by the European Commission. Updated monthly.


EMA PRIME Scheme

A list of products that have been accepted onto the PRIME (priority medicines) scheme, the European Medicines Agency’s initiative for helping to speed up the development and regulatory review of promising medicines for unmet medical needs. The list is updated monthly.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Winrevair, MSD's treatment for pulmonary arterial hypertension.

EU Biosimilar Filings, Opinions And Approvals

 
• By 

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.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.


Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU

 
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Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.

New EU Filings

 

Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Ixchiq, Valneva's chikungunya virus vaccine

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.