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

EMA Thumbs Up For Idorsia’s Insomnia Drug And Immunocore’s Uveal Melanoma Treatment

13 Products Recommended For EU-Wide Use; Ophthalmic Bevacizumab Rejection Confirmed

 
• By Vibha Sharma

An insomnia drug to improve daytime functioning, a treatment for a rare type of eye cancer, and an oral migraine drug for both acute and preventive treatment are among 13 new products recommended for pan-EU approval.

Multiple pills forming the flag of the EU.
Several New Drugs Are On Track For EU Approval • Source: Alamy

The European Medicines Agency has recommended insomnia drug Quviviq (daridorexant) and uveal melanoma treatment Kimmtrak (tebentafusp) for EU-wide approval. Developed by Idorsia and Immunocore, Ltd. respectively, both drugs were approved in the US last month.

If approved, Quviviq will become the first dual orexin receptor antagonist in Europe as well as the first insomnia medicine to improve daytime functioning, said Idorsia

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

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.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

More from Geography

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

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.