Marco Meglio

Based on its acceptance of the resubmission, FDA has assigned a PDUFA action goal date of January 31, 2025 for AXS-07.

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.

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.

The novel meloxicam/rizatriptan combination is thought to act via CGRP inhibition and provided significant and sustained headache pain freedom in both studies.

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.

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.

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.

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.

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.

Reports of migraine-related stigma were common in a recent population-based study, with nearly one-third reporting the experience often/very often.

AXIOMATIC-SSP is considered the largest clinical trial of activated factor XIa inhibition added to standard antiplatelet therapy for secondary stroke prevention.

Among study participants with migraine, investigators observed consistent and persistent device efficacy for pain relief, pain freedom, and functional disability freedom.

Ubrogepant 100 mg taken during the migraine prodrome significantly reduced onset of moderate or severe headache for 24 hours after study-drug dose.

Findings from phase 3 ACCORD clinical trial demonstrated rapid and sustained clinical response in patients with Alzheimer disease agitation with no new safety signals reported.

Ailiani, director of MedStar Georgetown Headache Center, focuses on optimizing treatment with CGRP inhibitors and where research on PACAP-targeting agents stands now.

Various illicit substances were detected in urine assays of 1 in 10 patients admitted to cardiac intensive care, according to findings of new French study.

The device from Nexalin Technology outperformed placebo on key measures of pain relief, sleep quality, anxiety, and quality of life.

Bayer's investigational FXIa inhibitor is currently being studied in a large-scale phase 3 development program expected to enroll more than 27 000 participants.

Approval of lecanemab under FDA's accelerated pathway requires the company to provide phase 4 study evidence to confirm the agent's clinical effect.