Prevision Policy Clips | Ipsen’s Palovarotene Heads To The Endocrinologic & Metabolic Drugs Advisory Committee Oct. 31

Prevision Policy Clips | ICER Advisory Panel Review Of Amylyx, Mitsubishi ALS Drugs Today May Include RWD Study

Prevision Policy Clips | Bluebird bio beti-cel (Zynteglo) FDA Approval

Prevision Policy Clips | Sweeping Drug Pricing Reforms Become Law As President Biden Signs Inflation Reduction Act Aug. 16

Prevision Policy Clips | Enhertu Accelerated Approval Used Project Optimus Advice

Prevision Policy Clips | First Medicare Price Negotiations Begin In October 2023 On Inaugural Cohort Of 10 Selected Drugs As The Inflation Reduction Act Heads To White House For Signing

Regulatory Approvals With More “Uncertainty” Should Be Considered In Pandemic-Related Therapeutic Development, National Academy Of Medicine Report Says

Prevision Policy Clips | House Democrats Will Attempt To Pass The Inflation Reduction Act And Related Drug Pricing Reforms Aug. 12

Prevision Policy Clips | Infant Formula Shortage Filling FDA Commissioner Califf’s Calendar

Prevision Policy Clips | Atara Tab-cel BLA May Be Possible Without Additional Clinical Trial

Drug Price Negotiations Threaten Stepwise Development Strategy, Lilly CEO Ricks Says; Shorter Lifecycles Force Larger First Launches

Prevision Policy Clips | CMS Rule On Medicaid Rebate “Misclassification” Is Pending At OMB

Drug Price Reform Bill Heads To House: Final Passage Likely August 12; Senate Tweaks Reduce Inflation Penalty Impact – But Not Fundamental Pricing Dynamics

Prevision Policy Clips | Drug Pricing Reform Clears The Senate: Modest Changes

Niemann Pick Advocates Push For Regulatory Flexibility, But FDA Stands Firm On Need For Placebo Controls

FDA “Enterprise Modernization” Needs More Funding To Move Past Pilot Stage; Inspections Are Early Focus Of Woodcock’s Priority Project

CBO Codas On Pricing Bill: Impact On Generic Drug Launches Not Analyzed, Budget Office Tells GOP Leaders; “Premium Stabilization” Is Key Variable For Part D Overhaul

Prevision Policy Clips | Sinema Says “Yes”: Drug Pricing Reform Likely To Pass Senate In Coming Days

FDA Advisory Committee “Update” May Result In More Meetings – And Re-Reviews When New Information Comes In, Califf Says

Prevision Policy Clips | FDA Opioid Framework Coming In Two Weeks: OTC Naloxone Carries “Complicated” Cost Issues, Commissioner Rob Califf Says

Prevision Policy Clips | Coherus Cimerli Interchangeable Biosimilar Approval To Lucentis

CMS New Technology Add-On Payments: Class Of 2023 Is Small, With Just Three New Products Qualifying For NTAP Status; Uplizna Rejected, Most Other Applicants Deferred

Prevision Policy Clips | OCE Project Optimus Dose Selection Initiative Cited By Allarity Therapeutics

FDA Public Tracking For Upcoming Externally-Led PFDD Sessions: Inborn Errors Of Metabolism, Neurology Conditions To Be Discussed Soon

Prevision Policy Clips | Part D Premium Deflation Sets Ironic Backdrop For “Inflation Reduction Act”