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Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs

 
• By Jessica Merrill

FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported.

Aduhelm's prescribing information was updated by FDA • Source: Alamy

A new safety update to the US prescribing information for Biogen, Inc.'s Aduhelm (aducanumab) – the first-of-its-kind, anti-amyloid antibody for Alzheimer's disease – presents more obstacles to use, but the drug already has been mostly sidelined by access restrictions.

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Leqembi Launch Set For Germany And Austria As EU Approval Finally Comes

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

GSK Ramps Up Neuroscience Investment With ABL Brain Shuttle Deal

 
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The pact could be worth more than $2.6bn and adds to growing big pharma investment in the technology.

Roche’s Brain Shuttle Delivers In Alzheimer’s, Moves Ahead To Phase III

 
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Axsome Plans Excessive Sleepiness Study In Depression After Phase III Failure

 
• By Alaric DeArment

The study’s failure in the overall MDD population was not a surprise, but solriamfetol’s efficacy in MDD with EDS provided a rationale for testing it in that subpopulation.

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MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
• By Joseph Haas

The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
• By Sushmita Panda

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Gilead Set To Expand Trodelvy/Keytruda Into Frontline TNBC

 
• By Alaric DeArment

The company reported positive topline results for ASCENT-04, which also bode well for the ASCENT-03 trial in patients with low PD-L1 expression.