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

Orphan Drugs Dominate EU Fast-Track Request Decisions In July

 
• By Maureen Kenny

The European Medicines Agency decided this month whether to grant fast-track review for planned marketing authorization applications for three potential new orphan treatments.

The accelerated assessment pathway can help get drugs to market faster • Source: Alamy

The European Medicines Agency was due to decide last week whether to grant fast-track status to the planned EU marketing authorization applications (MAAs) for four potential new treatments.* All but one of the four products have orphan status; filings for approval are likely to be submitted within the next few months.

The orphan products whose sponsors are seeking EU accelerated assessment are as follows:

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

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.