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Biogen and Alcyone Therapeutics Announce License and Collaboration Agreement to Evaluate a Novel Device to Improve Patient Experience and Access to Neurological ASO Therapies
Alcyone’s ThecaFlex DRx™ System is an implantable medical device in development for intrathecal drug delivery Biogen and Alcyone Therapeutics have entered into a license and collaboration agreement to develop Alcyone’s… More >>
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European Medicines Agency Accepts Tofersen Marketing Authorization Application to Treat Rare, Genetic Form of ALS
• SOD1-ALS is a rare, genetic form of ALS,1 comprising approximately 2% of people with ALS2 • If approved, tofersen would be the first treatment to target a genetic cause of ALS Biogen… More >>
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TRICALS statement on FDA approval of Amylyx AMX0035
During a meeting of the FDA’S Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) on Thursday September 29 2022, the Amylyx drug AMX0035 received conditional approval under the name… More >>
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Amylyx Pharmaceuticals Announces FDA Approval of RELYVRIO™ for the Treatment of ALS
• RELYVRIO (previously known as AMX0035 in the U.S.) is an oral, fixed-dose combination therapy for the treatment of adults with ALS • RELYVRIO significantly slowed loss of physical function in a… More >>
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With Tofersen, a first effective treatment is becoming available for ALS!
After decades of repeatedly negative clinical trial results, more than hope is emerging for ALS patients. Indeed, data from the VALOR study, a phase III clinical trial of tofersen in… More >>
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Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS
– FDA Advisory Committee voted 7:2 that the available evidence of effectiveness is sufficient to support approval of AMX0035 for the treatment of ALS – If approved, AMX0035 will be the… More >>
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AB Science announces filing of marketing authorization application for Alsitek in the treatment of amyotrophic lateral sclerosis (ALS) and its validation by the European Medicines Agency (EMA)
AB Science announced that it has filed an application for conditional Marketing Authorization to the European Medicines Agency (EMA) for Alsitek (masitinib) in the treatment of amyotrophic lateral sclerosis (ALS).… More >>
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Biogen ALS Community Statement on FDA acceptance new drug application for Tofersen
Dear ALS Community, We are writing to let you know that Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted Biogen’s New Drug Application for tofersen, an investigational drug… More >>
