Wednesday, October 2, 2024

CATEGORY

Biogen

Amyotrophic Lateral Sclerosis Treatment Advances: Tofersen’s Impact on Survival and Quality of Life

Key TakeawaysThe G-BA's assessment of Tofersen highlights significant survival and quality of life improvements for amyotrophic lateral sclerosis patients with SOD1 mutations, particularly...

Lupus: UCB and Biogen Announce Positive Results for Dapirolizumab Pegol in SLE

Key TakeawaysDapirolizumab pegol demonstrated clinical improvement in moderate-to-severe SLE patients. The drug also showed positive outcomes in reducing disease activity and flares. No...

Biosimilar OPUVIZâ„¢ Receives Positive CHMP Opinion for Aflibercept-Based Treatment in Ophthalmology

Key TakeawaysOPUVIZâ„¢, a biosimilar referencing aflibercept (Eylea), has received a positive recommendation from the EMA's CHMP for the treatment of several retinal disorders. ...

Spinal Muscular Atrophy Treatment Advances with Biogen’s Higher Dose Nusinersen Showing Significant Motor Function Improvements

Key TakeawaysBiogen's Phase 2/3 DEVOTE study demonstrated that a higher dose regimen of nusinersen significantly improves motor function in infants with spinal muscular...

Alzheimer’s Treatment Leqembi® (Lecanemab) Authorized for Early Alzheimer’s Disease in Great Britain

Alzheimer’s disease (AD) has taken another significant step forward in treatment, with the authorization of Leqembi® (lecanemab) in Great Britain for the treatment of...

Alzheimer’s Disease: LEQEMBI® (Lecanemab) Approved for Treatment in the United Arab Emirates

Alzheimer’s disease, a leading cause of dementia, has received a new treatment option in the United Arab Emirates (UAE) with the approval of LEQEMBI®...

Alzheimer’s Blood-Based Biomarkers Collaboration Aims to Transform Diagnostic and Therapeutic Approaches

Alzheimer’s collaboration aims to identify and develop accessible, minimally invasive blood-based biomarkers specific for tau pathology in the brain. These tools have the potential...

Alzheimer’s Collaboration to Develop Blood-Based Biomarkers for Tau Pathology in Alzheimer’s Disease

Alzheimer’s Collaboration to Develop Blood-Based Biomarkers and Tests for Tau Pathology aims to identify and develop accessible, minimally invasive blood-based biomarkers specific for tau...

CHMP Approves New Medicines and Biosimilars, Rejects Eisai and Biogen’s Alzheimer’s Drug

Despite the typical summer slowdown, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has shown no signs of reducing...

Alzheimer’s: Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union

Eisai and Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative...

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