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

Prevision Policy Clips | Covis Admits Defeat On Makena, But Still Hoping To Set Timeline For Withdrawal

Prevision Policy Clips | $200 Bil. More: Biden Budget Proposal Would Increase Number Of Medicare Negotiation-Eligible Drugs, Speed Up Timelines

Return Of The IPI? MedPAC Members Urge More Work On Part B Pricing After Current Set Of Recommendations Is Done; “Excessive Price” Authority Is Theme To Watch

Prevision Policy Clips | Leqembi Advisory Committee Review Will Be Another Accelerated Approval Milestone

GSK RSV Vaccine Arexvy: Two Strong Votes By FDA Committee Are Tempered By Repeated Suggestions To Wait For Second Year Data

Prevision Policy Clips | FDA's Revamped Manufacturing Inspections Platform Will Launch In 2024

FDA Artificial Intelligence In Drug Manufacturing Discussion Paper Raises The Issue That Data Management Practices May Affect Inspections

PBM Formulary Design Is One Focus Of Broad Request By GOP House Committee To CVS, Express Scripts And Optum; GPO Affiliates Also Draw Questions

Prevision Policy Clips | CMS Updates Drug Spending Dashboards With 2021 Data But Cautions Against Direct Read-Through For “Negotiations”

Advisory Committee Tracker: AZ/Merck Lynparza Prostate Cancer Review Extended For ODAC; Paxlovid NDA Conversion Heads To Panel

Pfizer RSV Vaccine Clears FDA Committee By Narrow Margins: Discomfort On Safety, Limited Case Counts And “Rushed” Process Is Warning For FDA

Prevision Policy Clips | AstraZeneca/MSD’s Lynparza Goes To FDA Advisory Committee For First-Line Metastatic Prostate Cancer

Prevision Policy Clips | CDER Liver Drug Division Acting Director Is Frank Anania

FDA AI/ML Discussion Paper Will Clarify Issues Around Use Of Artificial Intelligence In Drug Development; FDA Device Effort Provides Model

FDA Neurology Office Deputy Buracchio Is Acting Head Following Dunn’s Exit; Consistency A Plus – But Another Neurologist Bites The Dust

FDA Evidence Generation Taxonomy, Gene-Editing Information Sharing Initiatives Unveiled By Commissioner Califf As Second Year Priorities

Prevision Policy Clips | CDER Office Of Compliance Director Jill Furman Will Stay On

Pfizer, GSK RSV Vaccine Candidates: Tandem Reviews To Showcase FDA Post-COVID Vaccine Work And Leadership

Gene Therapy BLA Review Teams Will Stay Together As Office of Therapeutic Products Launches Feb. 26; Communication Pilot Will Be Early Highlight

Prevision Policy Clips | Pfizer Paxlovid EUA-To-NDA Conversion Heads To Advisory Committee March 16

Prevision Policy Clips | Alzheimer’s Medicare Coverage Policy Will Not Be Reconsidered

Prevision Policy Clips | Long COVID Patient-Focused Drug Development Meeting: FDA Sets April 25 Date

The New Part D: CBO Estimates Net Drug Spending Will Decline By $42 Billion With All IRA Changes Factored In; Savings Estimates Assume Average 50% Cut For “Negotiated” Prices