1. Scrip
  2. >>Business

Aduhelm Looks Set For Rejection In Europe For Alzheimer's

Adds To US Woes

 
• By Andrew McConaghie

The EMA’s likely rejection is no surprise for Biogen and Eisai, but adds to problems in the same week as Biogen’s R&D leader announced his departure.

Biogen_Switzerland
Hopes of an EU launch in 2022 are now diminishing, with EU regulators expected to demand a further trial to demonstrate Aduhelm' s efficacy. • Source: Alamy

The European Medicines Agency’s expert committee looks set to reject Biogen and Eisai’s Alzheimer’s treatment Aduhelm (aducanumab), adding further bad news to the drug’s troubled and controversial US launch.

The companies announced on 17 November that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Business

Finance Watch: OrbiMed’s New $1.86bn Fund Offers Financial Alternatives In Tough Market

 
• By Mandy Jackson

Public Company Edition: OrbiMed partners Carter Neild and Matthew Rizzo spoke with Scrip about the firm’s fifth royalty and credit fund. Also, Ligand sold $400m worth of notes, BridgeBio’s oncology spinout went public via SPAC merger and raised $261m and Assembly raised $175m.

Asia Deal Watch: Lupin Picks Sandoz To Market Lucentis Biosimilar In Parts Of EU And Asia

 
• By Joseph Haas, Sushmita Panda, Xu Hu, Vibha Ravi, and Manas Mishra

Also deals involving Xspray/Handa, Fosun/Expedition, Kaken/Astria, Orchid/Allecra, Sanofi/Visirna, KKR/Healthcare Royalty Partners, Viridian/Kissei, Sandoz/Evotec, Dx&Vx, Dr. Falk/Allianthera, Madrigal/CSPC and Lilly/LTZ.

PureTech’s New Spin-Off Wants Partners For Pulmonary Fibrosis Drug

 
• By Andrew McConaghie

Deupirfenidone hit its Phase II endpoint but the program remains risky and PureTech’s new Celea Therapeutics will aim to pull in extra funding for its late-stage development.

Stock Watch: Sanofi And Merck Temper Big Pharma Q2 Earnings Cheer

 
• By Andy Smith

The investor enthusiasm that greeted initial second-quarter pharma earnings announcements was dampened by the results from Sanofi and Merck & Co. Sanofi was particularly punished by investors despite overall growth, while Merck’s revenue fall was probably baked into expectations.

More from Scrip

Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 
• By Andrew McConaghie

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

Stock Watch: Sanofi And Merck Temper Big Pharma Q2 Earnings Cheer

 
• By Andy Smith

The investor enthusiasm that greeted initial second-quarter pharma earnings announcements was dampened by the results from Sanofi and Merck & Co. Sanofi was particularly punished by investors despite overall growth, while Merck’s revenue fall was probably baked into expectations.

Japan Results Roundup: Reduced Forex Impact, Uncertain US Tariff Outlook

 
• By Lisa Takagi

Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.