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Marco Meglio
Articles
Axsome Therapeutics: FDA Accepts NDA Resubmission for AXS-07 for Acute Treatment of Migraine
September 16, 2024
Based on its acceptance of the resubmission, FDA has assigned a PDUFA action goal date of January 31, 2025 for AXS-07.
Lecanemab Will Be Evaluated in Preclinical Alzheimer Disease with Novel Study Design
August 13, 2024
The AHEAD study program will use plasma biomarker screening, novel PET agents, and other unique approaches to assessing lecanemab effect at the earliest stage of disease.
Donanemab FDA AdComm Hearing Scheduled for June 10, Eli Lilly Says
May 08, 2024
The AdComm plans to review data from the TRAILBLAZER-ALZ 2 phase 3 clinical trial that served as the foundation for Eli Lilly's original BLA submission to the FDA.
Axsome's Novel AXS-07 Formulation Effective Against Migraine in Pooled Phase 3 Study Analysis
May 01, 2024
The novel meloxicam/rizatriptan combination is thought to act via CGRP inhibition and provided significant and sustained headache pain freedom in both studies.
Erenumab Rx Early in Episodic Migraine Found Superior to Oral Prophylactic Agents for Efficacy, Tolerability, Adherence
April 01, 2024
The phase 4 APPRAISE trial found greater efficacy with erenumab after failure with 1 or 2 other preventives vs ongoing treatment with the nonspecific oral agents.
Lundbeck Moves PACAP-Targeting Antibody into Multinational Phase 2b Clinical Trial
March 18, 2024
PROCEED will assess the efficacy and safety of the PACAP antagonist as a migraine preventive in individuals who have failed to get relief from up to 4 agents.
Lilly Investigational Alzheimer Agent Donanemab Phase 3 Findings Under FDA Review
March 08, 2024
The surprise request for review of the phase 3 TRAILBLAZER-ALZ-2 clinical trial findings will delay the original PDUFA timing beyond first quarter 2024.
Functional Deficits Poststroke Found More Pronounced in Study Group with Lower Mean Oxygen Saturation During Sleep
February 26, 2024
At 3 months following ischemic stroke, lower mean oxygen saturation but not apnea-hypopnea index was associated with functional deficits, according to a French research team.
Apixaban Reduced Risk of Stroke in Subclinical Afib Relative to Aspirin but with Greater Risk of Bleeding: ARTRESIA Trial
February 02, 2024
In apixaban-treated participants, risk of stroke or systemic embolism was reduced by 37%; the risk of disability or fatal stroke declined by 49%, but with noted bleeding risk.
Migraine-related Stigma is Common and Impacts Level of Disability, Quality of Life
January 25, 2024
Reports of migraine-related stigma were common in a recent population-based study, with nearly one-third reporting the experience often/very often.