FDA “Safe Import Action Plan” Sets Bad Precedent For Pharma, But Buys Time To Reframe Debate; First Step Is Positive, Rulemaking Will Delay Bigger Changes

Prevision Policy Clips | FDA “Safe Import Action Plan”: Immediate Focus Allows Manufacturers To Bring Lower-Cost Alternatives

Gene Therapy Installment Payment Model For Medicaid Included In Senate Finance Pricing Bill

RWE Duplication: FDA Strategy To Replicate Clinical Results Begins In Diabetes Space—Replicating Sentinel Start-Up Plan?

Prevision Policy Clips | CMS Proposes To Continue 340B Payment Cut While Appeal Is Pending

Dose Of Reality For Real-World Evidence: Pfizer Ibrance Supplement Relies On RWE – But FDA Approval Relies On Traditional Study

Advisory Committee Tracker: Opioid Policy Shifts Mean Setback For Nektar; Intra-Cellular Committee Cancellation Further Thins Summer Schedule

Prevision Policy Clips | House Oversight Committee Plans Drug Pricing Hearing With Pharma Execs

The New Part D Discount: Break-Even Point For Brands Is At Price Of $31,000

Prevision Policy Clips | Pfizer’s Xeljanz Adds Boxed Warning On Blood Clots And Death With High Dose; UC Indication Narrowed

BI Ofev Use In Scleroderma Wins Narrow Positive Vote From FDA Committee; “Modest” Benefit Good Enough For Most Panelists

“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