Infographic: Leqembi – A Geographical Comparison

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

Eisai and Biogen's follow-up Alzheimer's treatment has met with varying success around the globe. (Shutterstock/AI-generated)

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 Regional Comparisons

Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls

 
• By 

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

Early Support For EMA’s Trial Of US-Style Standards In Non-Clinical Reviews

 
• By 

An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
• By 

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

More from Europe

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By 

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.