“Estimand” Is FDA’s Estimable Approach To Oncology Patient Outcomes: Framework For More Useful, Usable Patient Data In NDAs

Rebate Ban Could Be Revived As Senate Pricing Bill Moves Forward; WAC Inflation Penalty Stays In – For Now

Prevision Policy Clips | Trump Drug Pricing Executive Order Threat Renewed, But Diminished In Light Of Senate Progress

What’s Next For “Netflix” Drug Pricing Models? Insulin, Sickle Cell Treatments May Be One Place To Start

Prevision Policy Clips | Intra-Cellular Advisory Committee For Schizophrenia Drug Lumateperone Canceled By FDA

Clinical Trial Risk-Based Monitoring: Successful Plans Have Been Based On Clear Risk Identification; Centralized Monitoring Alone Does Not Suffice

Boehringer Ofev Supplement Will Test Whether Lung-Function Surrogate Can Apply To New Setting (SSc-ILD); Replay Of IPF Experience Could Help Sponsor

Part D Overhaul Would Set 20% “Catastrophic Discount” From Pharma; Beneficiary OOP Capped At $3,100 By Senate Finance; Part B Spread Capped At $1,000

House Drug Price Negotiation Bill Will Focus On Post-Patent Brands; Proposal Coming In September – But Impact Is Likely To Come In Future Administration

Prevision Policy Clips | Democratic Drug Negotiation Proposal To Be Unveiled In September: Focus Is On Late Lifecycle Single-Source Drugs

LPAD Questions Persist: Industry, Stakeholders Ask for Clarification On Anti-Infective Pathway

Prevision Policy Clips | Patients To Testify At House Oversight Committee Drug Pricing Hearing July 26

Prevision Policy Clips | Register Now For The Biopharma Congress

Prevision Policy Clips | METRIC Price Justification Bill Moves To House Floor

FDA’s Temple Leaves Skeptical Impression On Role Of RWE: What's The "Real World" Application?

Senate HELP Drug Pricing Provisions Would Deliver Modest But Measurable Savings, CBO Says; PBM Transparency Will Have Short Term Impact That Erodes Over Time

Prevision Policy Clips | Drug Pricing Measures In Senate HELP Bill Would Reduce Deficit By $4.6 Bil.

Cures II: What To Watch In The Years Ahead

HHS Management Of Medicare Does Not Give It Authority To Control Drug Prices: DTC Ad Ruling May Carry Broader Implications

Prevision Policy Clips | E&C Committee To Mark Up Drug Price Transparency Bill Package July 17

Prevision Policy Clips | Register Now For The Biopharma Congress October 7 In Washington, DC

Prevision Policy Clips | Grassley Weighs In On Rebate Rule Withdrawal, Not A Fan

Drug Pricing Transparency “METRIC” Act Clears E&C Health Subcommittee With Full Committee Markup Slated For The Week Of July 15

Rebates Redux: Rebate Rule Withdrawal Opens Drug Price Reform To Less Appealing Options For Pharma, Including Non-US Reference Prices, Arbitration

Prevision Policy Clips | International Pricing Index, Importation Emerge As Rebate Rule Is Officially Withdrawn