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Bad News For Amylyx As EMA Upholds Rejection Of ALS Drug Albrioza

 
• By Eliza Slawther

The European Medicines Agency stood by its initial decision to recommend against EU approval of Amylyx’s ALS drug Albrioza after a re-examination, but the company remains hopeful that further trial evidence could support a future EU authorization.

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• Source: Shutterstock/meikesen

Amylyx Pharmaceuticals this week failed to convince the European Medicines Agency that its amyotrophic lateral sclerosis (ALS) drug Albrioza (sodium phenylbutyrate/ursodoxicoltaurine) should be approved in the EU, despite the drug having already secured conditional approval in Canada in June 2022 and full regulatory approval in September 2022 in the US, where it is marketed as Relyvrio.

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More from Europe

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

CSL Makes Landmark National-Level Pay-For-Performance Deal In Germany For Hemgenix

 
• By Francesca Bruce

A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.

More from Geography

US FDA Staff’s Union President Calls For More Support From Industry

 
• By Sarah Karlin-Smith

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.