Prevision Policy Clips | Merck Constitutional Challenge Of IRA Drug Price Negotiations

FDA “Advancing RWE” Initiative Offers “All Hands On Deck” Review Of Real-World Data Proposals; First Selections Have Been Made, Details To Come

AZ/Sanofi’s Nirsevimab For RSV: FDA Highlights Demonstrated Efficacy Better Than Synagis, Few Safety Concerns Ahead Of June 8 Advisory Committee Review

Prevision Policy Clips | BrainStorm Says Filed-Over-Protest NurOwn ALS Cell Therapy Will Get FDA Panel Review September 27

Prevision Policy Clips | J&J COVID Vaccine Withdrawn From US; FDA Formally Revokes EUA

FDA Migraine Prevention Draft Guidance Confirms Separate Trials For Episodic And Chronic Indications; Recent Approvals Have Incorporated That Approach

Prevision Policy Clips | Former CMS Chief Of Staff Mandy Cohen To Be Next CDC Director

Prevision Policy Clips | Leqembi Coverage Will Be Supported By “Nationwide, CMS-Facilitated Portal”

Prevision Policy Clips | OCE Director Pazdur “Exploring Temporary Importation” Of Cancer Drugs In Shortage, Raises Idea Of “Buffer Stockpile”

FDA Patient Medication Information Proposal Includes Five-Year Phase-In For All Drugs To Have One-Page Summaries; Best Practices Partnership Suggested Rather Than Consumer Testing Mandate

Advisory Committee Tracker: AstraZeneca/Sanofi RSV Antibody, COVID Booster Strategy Meetings Highlight June Agenda

Prevision Policy Clips | FDA Patient Medication Information Proposed Rule: Will Third Time Be A Charm?

Prevision Policy Clips | FDA Adjusting For Covariates In RCTs Guidance: Recap Podcast

HbA1c Affirmed As Diabetes Endpoint Of Choice In New FDA Draft Guidance; Agency Offers Approaches To Incorporate Hypoglycemia Reduction

PBM Bills Advance In House As Part Of PATIENT Act; 340B Transparency, Gene Therapy Medicaid/VBP Measures Also Clear E&C Committee

Prevision Policy Clips | Diabetes Drug Efficacy Guidance: Hemoglobin A1c Is “The Accepted Primary Endpoint,” Hypoglycemia Incidence Reduction “Advantage”

Medicaid Price Negotiation? CMS Proposes “Survey” Process For High-Cost/High-Spend Drugs As Tool To Encourage Price Concessions; Rule Includes Numerous Other Rebate Program Tweaks

Artificial Intelligence Will Be Key In Helping FDA Streamline Next-Gen Cell Therapies; “Great Advances” Coming In Next 10 Years

How Can FDA Advance Cell Therapy R&D? Issue Guidance in “Real Time,” Encourage Collaboration With Industry, CBER’s Marks Says

Prevision Policy Clips | Medicaid “Price Verification Survey” Proposal Seeks To Apply Pressure For Supplemental Rebates/VBP Agreements

Intercept OCA NASH Indication Will Wait For Outcomes Data; Attempt To Win Committee Support For Accelerated Approval By Cutting Target Market Fails

“Platform” Pathway Will Not Be “One Size Fits All,” FDA Says; CAR-T Therapies May Be Early Models For Leveraging Data Across Products, FOCR White Paper Suggests

Prevision Policy Clips | What’s Holding Back Cell Therapies? CBER’s Marks Says Artificial Intelligence Can Help

Warp Speed For Real-World Evidence? CDER Director Cavazzoni Suggests RWE Adoption May Require Acceleration; AdCom Revamp Takes Shape

Prevision Policy Clips | First Topical Gene Therapy: Krystal Biotech’s Vyjuvek Approved By FDA For Rare Skin Disease