Prevision Policy Clips | FTC Enforcement, Drug Importation Plans Expected To Be Themes In Biden Executive Order

Prevision Policy Clips | Biogen/Eisai And FDA Update Aduhelm Label To Emphasize Use In Early-Stage Alzheimer’s

CMS Leadership Team Brings Lessons Learned From Obama Era Pricing And Access Policy Debates

Prevision Policy Clips | CMS Medicare Head Seshamani Joins From MedStar Health, Is Obama-Era Veteran

CDER Leadership: Corrigan-Curay Confirmed As Top Deputy To Director Cavazzoni; Medical Policy Will Be Led By Deputy ElZarrad

Prevision Policy Clips | Part B Cuts For 340B Drugs Will Be Reviewed By Supreme Court

Prevision Policy Clips | Merck Agrees To Pull “Dangling” Keytruda Gastric Cancer Claim

Prevision Policy Clips | FDA Final Guidance On CNS Metastases In Cancer Includes A Number Of Clarifications

FDA Appropriators Request Report On COVID Impact On Trials; Foreign Inspection Funding Is Key Priority, While Lupus, DMD Are Among Specific Diseases Highlighted In House Report

Patient Experience Data Use Report Highlights FDA Adjustments To “Learning Curve” In “Evolving” Field

Prevision Policy Clips | Aduhelm Cost-Effectiveness Debate: Biogen Will Join ICER Roundtable July 15

Advisory Committee Tracker: Sparse Agenda As Summer Begins And Process Faces Scrutiny Inside And Outside FDA

Prevision Policy Clips | FDA Releases Three Underlying Aduhelm Reviews

FDA Osteoarthritis Workshop Demonstrates Ripple Effects Of Aduhelm Approval; Biomarkers As Surrogates Pushed, But Not Ripe In FDA View

Prevision Policy Clips | House FDA Appropriations Includes Funds To Support “Unannounced, In-Person Inspections”

Prevision Policy Clips | House FDA Funding Bill Would Increase Baseline Appropriations By $269 Million

FDA “Reassessing” Single-Arm PD-1 Oncology Trials: “Pazdur Moments” Lead To Advisory Committee Vote Against Incyte’s Retifanlimab Pending More Data

Complex Generics: Oligonucleotides May Feature In GDUFA-Funded Research; FDA Highlights COVID Lessons In Adoption Of New Modeling For BE Studies

Prevision Policy Clips | The Aduhelm Precedent In Action: FDA Grants “Breakthrough” Status To Novel Beta Amyloid Treatments

Woodcock’s FDA: Confident Decisions With Welcome Dissent

The Aduhelm Precedent: Beta Amyloid Correlation To Cognitive Data Is Key For Other Alzheimer Sponsors

CURES 2.0 Prods FDA On Familiar Topics More Than Seeking Major New Initiatives: RWE And Gene Therapies Sections Demonstrate Reminder Approach

Prevision Policy Clips | Biogen/Eisai Suggest Aduhelm Target Population Is 1-2 Million

Senate Democratic Drug Pricing "Principles" Retreat To Abstraction In Effort To Restart Price Negotiation Push; One Specific Is Repeal Of Rebate Rule

CDER Sought Extensive In-House Advice On Aduhelm Accelerated Approval, Cavazzoni Says; FDA Is On “Very Solid Ground” In Applying Pathway