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

Idorsia’s Insomnia Drug Daridorexant Among 14 Hopefuls For EU Verdict

Immunocore’s Tebentafusp Could Also Get A Marketing Recommendation

 
• By Vibha Sharma

The European Medicines Agency will likely decide this week whether to recommend for pan-EU approval new treatments for insomnia, uveal melanoma, migraine and advanced prostate cancer.

Thumbs
Yes Or No? Its Crunch Time For Companies As EMA Meets To Adopt Opinions On Several Marketing Authorization Applications • Source: Shutterstock: Little Pig Studio

Swiss biotech firm Idorsia Pharmaceuticals is set to learn this week whether its insomnia drug daridorexant is on track for EU-wide approval. The drug was authorized as Quviviq in the US in January.

Immunocore could also hear whether its T-cell receptor (TCR) therapy tebentafusp will be recommended for approval for the treatment of uveal melanoma. Tebentafusp too was approved in the US in January, as Kimmtrak

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

More from Geography

Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma

 
• By Sarah Karlin-Smith

The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.