Prevision Policy Clips | Merck, Bristol Reassure Investors That FDA Reviews Are Proceeding On Time For Now

340B Contract Pharmacy Restrictions’ Impact Is Waning, Manufacturers Tell Sen. Cassidy; Report Quantifies Effect On Lilly, J&J, And Amgen, Fuels Cassidy’s Call For Reforms

FDA Expands Catalogue Of Rare Disease Case Studies: New Examples Look At Surrogate Endpoints (Qalsody, Nexviazyme, Livdelzi), Externally Controlled Trials (Amvuttra) And Novel COAs (Bylvay)

Making “Cost-Effective” Drugs “Affordable”: ICER Obesity White Paper Offers Options To Expand Access To GLP-1s For Insurers, Policymakers To Consider

Prevision Policy Clips | FDA Rare Disease Case Studies Include Biogen’s Qalsody And Alnylam’s Amvuttra

FDA Layoff Impact On Review Activities Detailed By CDER In Letter To Vanda; Message In Context Of Dispute May Have Broader Audience In Mind

Prevision Policy Clips | Novavax COVID BLA Review: Company Asked For Post-Marketing Commitment “To Generate Additional Clinical Data”

MASH Histology Assessment AI-Assisted Tool Approved In Europe; Biomarker’s Qualification Is Ongoing At FDA

Nanoscope Retinitis Pigmentosa Treatment Would Benefit From Value-Based Contracting, ICER Says; Panel Revisits Ophthalmic Gene Therapy Seven Years After Luxturna

Prevision Policy Clips | OCE Loses Two More: Associate Director For Biomarkers And Precision Oncology Reena Philip

Conditional Approval Pathway For Ultra-Rare Conditions Based On “Plausible Mechanism” Floated By FDA Commissioner Makary

Prevision Policy Clips | CMS Center For Medicare Director Is John Brooks

FDA Advisory Committee Industry Reps Sacrificed To “Radical Transparency”; Commissioner Makary Defends FDA Cuts In On-Line Interview

Prevision Policy Clips | No More Industry Reps: FDA Advisory Committees Will No Longer Have Company Executives

CAR-T Differences Debated Again In CMS Discussion Of NTAP Applicants For FY 2026; 13 Drugs Seek New Technology Add-On Payments

Prevision Policy Clips | HHS Draft Budget Proposal Protects User Fee “Triggers,” But Cuts FDA Appropriations

Improving The IRA: Trump Drug Pricing Executive Order Has Many Positives For Pharma, Though HHS Demo Is Threat To Monitor; Policy Menu Largely Unchanged From 2017

Prevision Policy Clips | Improving The IRA: Trump Drug Pricing Executive Order Includes Call To End “Pill Penalty”

Prevision Policy Clips | FTC Looking To Roll Back “Anti-Competitive Regulations”

Saving Part D: MedPAC Debates Ways To Make Stand-Alone Plans More Viable; Warns That Future Of Traditional Medicare May Be At Stake

Fixing Biosimilars: Stelara Will Be Test Of Price Negotiation Impact; FDA Cuts May Have Significant Adverse Effect At Tough Time For Sector

“A Slow Moving Catastrophe”: FDA Layoffs Will Result In Less Guidance And Less Flexibility, Ex-Leaders Suggest; Cell/Gene Therapy Could Be A Bright Spot

Prevision Policy Clips | Digital Health Technologies In Clinical Trials: FDA Viewpoint Posted In JAMA

FDA “Five-Office” Reorg Proposal Criticized By Former Senior Officials; Regulatory Work Is Too Specialized For A “Big Team Of Generalists”

RFK At FDA: “Dissidents Will Be Listened To,” HHS Secretary Kennedy Says; Commissioner Makary Calls For “More Teamwork,” Less “Individual Empires”