PatientSpotlight, by PanaceaIntelPatientSpotlight

Topic

Safety

Coverage of safety signals across the therapy areas we follow - surveillance protocols, the operational reality of monitoring, and what real-world data tell us about safety beyond the trials. 9 pieces on this topic across therapy areas, newest first within each collection.

Signals

5
SignalApr 26, 2026FDA · EMA · peer-reviewed

JAK class label restrictions are reshaping moderate-disease prescribing

FDA boxed warnings and EMA caution have repositioned JAK inhibitors as later-line agents in rheumatoid arthritis, atopic dermatitis, and psoriatic arthritis - reshaping the practical sequencing decision in moderate disease.

TreatmentRegulatorySafetyAccess
SignalApr 26, 2026FDA · industry-filing · peer-reviewed

Non-hormonal vasomotor symptom options are now in routine use

Fezolinetant uptake has been faster than analyst projections, and the field is now in the post-launch phase where prescribing patterns, payer coverage, and longer real-world safety data shape adoption.

TreatmentMenopauseRegulatorySafety
SignalApr 23, 2026registry · peer-reviewed · health-system

Real-world ARIA rates from registries are landing close to trial estimates

Early registry data on lecanemab and donanemab in routine clinical use is producing ARIA incidence numbers that broadly track the pivotal trials, with APOE4 homozygotes consistently the highest-risk group.

SafetyBiomarkersAccessGenetics
SignalMar 28, 2026FDA · health-system

ARIA surveillance is becoming the rate-limiting step in anti-amyloid care

Amyloid-related imaging abnormalities require protocol-defined MRI at multiple intervals, and managing positive findings demands neurologist judgment that is in short supply.

SafetyInfrastructureAccess
SignalMar 22, 2026FDA · peer-reviewed

APOE4 genotype is reshaping eligibility, dosing, and disclosure

Anti-amyloid trial readouts and post-marketing surveillance both show APOE4 homozygotes face higher ARIA risk - pushing genotype testing into pre-treatment workflows.

GeneticsSafetyTreatment

Snapshots

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Explained

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