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Decoding regulatory agency decisions – The case of Amylyx’s Relyvrio-Albrioza in the US and EU
Amylyx’s ill fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores… More >>
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Biogen Receives European Commission Approval for QALSODY® (tofersen)
Biogen announced the European Commission (EC) has granted marketing authorization under exceptional circumstances and maintained orphan designation for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS)… More >>
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Biogen and Ionis Announce Topline Phase 1/2 Study Results
Biogen announced the European Commission (EC) has granted marketing authorization under exceptional circumstances and maintained orphan designation for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS)… More >>
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Amylyx Pharmaceuticals Announces Formal Intention to Remove RELYVRIO®/ALBRIOZA™ from the Market
Amylyx announced the Company has started a process with the U.S. Food and Drug Administration (FDA) and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA™ (sodium phenylbutyrate and… More >>
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top-line results European phase 3 clinical trial of TUDCA
Announcement of top-line results. The TUDCA-ALS consortium announces top-line results from the European phase 3 clinical trial of TUDCA in patients with amyotrophic lateral sclerosis (ALS). The TUDCA-ALS study did… More >>
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Ferrer and Verge Genomics Announce Agreement to CoDevelop Clinical-Stage ALS Therapy VRG50635
Verge Genomics, a leading clinical-stage biotechnology company, and Ferrer, an international B Corp pharmaceutical company with an increasing focus in rare neurological disorders, have announced a strategic collaboration to co-develop… More >>
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AMYLYX PHARMACEUTICALS ANNOUNCES TOPLINE RESULTS FROM GLOBAL PHASE 3 PHOENIX TRIAL OF AMX0035 IN ALS
Amylyx Pharmaceuticals announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S.,… More >>
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Biogen Community Statement on Tofersen CHMP Opinion
Dear European Organization for Professionals and Patients with ALS, Thank you for your request to receive updates about QALSODY® (tofersen). We are writing with the news that the Committee for Medicinal… More >>

