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Second Biogen/Eisai Antibody Moves AHEAD, In Asymptomatic Alzheimer’s

Early Intervention Benefits?

 
• By Ian Haydock

More progress for partners’ amyloid-targeting antibody portfolio as they look to demonstrate benefit of early intervention in pre-symptomatic disease in new collaborative Phase III trial.

Elderly woman hands holding missing white jigsaw puzzle piece down into the place as a human head brain shape. Creative idea for memory loss, dementia, Alzheimer's disease and mental health concept.
New Trial To Add To Alzheimer's Puzzle? • Source: Shutterstock

Hot on the heels of a high-stakes US filing, Biogen, Inc. and partner Eisai Co., Ltd. are moving forward with a new Phase III study for the second of two amyloid-targeting antibodies being developed under their alliance for Alzheimer’s disease.

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Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By Joseph Haas

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

In Brief: Genmab To Seek FDA Nod For Epkinly In Lymphoma

 
• By Sushmita Panda

Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

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AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

Moderna Punts On US Vaccine Policy Changes, Will Focus More On Cancer

 
• By Joseph Haas

On its Q1 earnings call, Moderna avoided criticizing policy changes affecting vaccines but de-emphasized its flu/COVID-19 vaccine for under-50 and prioritized cancer programs.