Prevision Policy Clips | CMS Talking Points On Drug Pricing Reform Implementation Emphasize Insulin Co-Pay Cap And Premium Subsidies

FDA “Act For ALS” Action Plan Will Support Drug Development “In Real Time”; Agency Outlines First Steps In Five-Year Implementation

Prevision Policy Clips | CBER Director Marks Pressed Then-FDA Commissioner Hahn On COVID Vaccine EUA Guidance Decision

IRA Reset: Gene Therapies Have Price Model To Dodge “Drug Price Negotiation Program;” For Negotiated Products, Who Negotiates Matters

Prevision Policy Clips | FDA Looks To Broad Consortia To “Stimulate Progress In Evidence Generation”

FDA Will Allow Cost Distribution For Manufacturing, Administrative Startup For Expanded Access Programs, Updated Guidance Says

Prevision Policy Clips | Pfizer/BioNTech COVID-19 BA.4/5 Bivalent Vaccine Doses Will Be Ready For September Delivery

Amylyx ALS Drug Gets Positive Review By ICER Ahead Of Second FDA Advisory Panel; ICER Group Finds Expected Launch Price Too High

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