ICER Says Lecanemab Has Insufficient Net Health Benefit, “Low” Long-Term Value At Current Pricing; Post-Approval Evidence Will Be Key, But How?

“Conditional Approval” Redux? FDA Gives Advisory Committee “Two Scenarios” For Biogen/Ionis’ Tofersen In ALS: Accelerated Approval Or Full Approval

Prevision Policy Clips | CDER Office Of Compliance Annual Report

Biomarker Studies Proposed For Use In Labeling Require Subject-Level Data Submission, FDA Says In Revised PKG Guidance; “Voluntary” Program Ending

Opioid Overdose Treatments In Spotlight At FDA Workshop; Agency Hopes To Spread Message That Abstinence Is Not The Only Acceptable Endpoint

Paxlovid Endorsed For EUA-To-NDA Approval On Strength Of FDA Reassurances On Efficacy; DDIs Are Main Safety Concern

Prevision Policy Clips | Sarepta DMD Gene Therapy Will Go To Advisory Committee Ahead Of May 29 User Fee Deadline

CMS Casts Broad Net For Price Negotiation Targets: All NDAs With Same “Active Ingredient” Will Be Covered By “A Single Price”; Tight Timeline For Biosimilar Sponsors To Seek Delays

CMS Price Negotiation Benchmarks: Reference Pricing Tied To Therapeutic Alternatives Where Available, FSS Pricing Where Not; “Starting Point” Is Likely Key To Final Price

Prevision Policy Clips | CBER Gene Therapy “Super Office”: Witten’s Interim Director Role Likely To Run At Least Into Summer

Part B Inflation Rebate List Released By CMS: No Major Products Affected, First Year Collections May Not Reach $20 Million

Prevision Policy Clips | FDA Draft Guidance On Long-Acting Local Anesthetics Encourages Data Collection On Opioid Use

Pfizer Paxlovid NDA Conversion Complicated By Lack Of Efficacy In Vaccinated Populations; Approval Still Likely Heading To Panel Review

GAO Report Spotlights FDA Advanced Manufacturing Initiatives, Urges Agency To Flesh Out Metrics For ETP and FRAME

Prevision Policy Clips | Veterans Affairs Department To Cover Eisai/Biogen’s Leqembi For Alzheimer’s But Restricts Use To 65 And Older

Get Ready To DANCE: FDA/Duke RWE Negative Controls Meeting Features Two Projects, But Agency Says Activities Are Only At “The Start”

Prevision Policy Clips | GAO Advanced Manufacturing Report Spotlights FDA Efforts

FDA Proposes Emerging Pathogens Preparedness Program As PAHPA Add-On In Budget “Wish List”; LDTs Not Included In Requests To Congress

“Infected Trials,” Remote Inspection Guidances Among 18 CBER/CDER COVID Policies That Will Be Retained Post-Emergency; FDA Outlines Wind-Down Plan For Others

Genentech Polivy Wins Strong Support For First-Line DLBCL Claim Despite Skeptical FDA Review; ODAC Losing Streak Over

Prevision Policy Clips | FDA’s Gastrointestinal Drugs Advisory Committee To Review Intercept’s Ocaliva For NASH On May 19

HCV Subscription Model Is $11 Bil. Silver Lining For Drug Developers In White House Budget; Price Cuts Are Much Bigger Item, But Far Less Viable

Prevision Policy Clips | House Opioid Bill Would Require Manufacturers And Distributors To Report “Suspicious” Orders

Cell Therapy “Assessment Aid” Would Encourage Use Of Data Extrapolation For Next-Generation Oncology Indications; CBER Is Open To Idea

FDA Questions “Modest” Efficacy Of Genentech Polivy In First-Line DBCL Setting; Accelerated Approval Status For Refractory Disease Not At Issue For Panel Review