Prevision Policy Clips | FDA Commissioner Califf Highlights Patient Engagement Efforts At Digital Health Event

Prevision Policy Clips | CDC Overhaul Will Be Led By New Director: Walensky To Step Down

Sarepta DMD Advisory Committee Has High-Profile Audience: FDA Commissioner Pressed To Allow More Public Speakers During Senate PAHPA Reauthorization Hearing

Gene & Cell Therapy Postmarket Surveillance: “Lifelong” Follow-Up, Multi-Sponsor Registries Pique FDA Interest; Guidance Coming

Opill OC Non-Prescription Switch Unlikely To Win Committee Support Based On List Of FDA Concerns; New Study Plus “ACNU” Rule May Be Enough, But FDA May Prefer New Product – Or Sponsor

“Anti-Aging” R&D? One Drug To Prevent Many Diseases Is Possible, But Endpoints First Need Outside Work To Find Scientific Consensus, FDA’s Califf Says

Prevision Policy Clips | Intercept OCA For NASH: FDA Grants Three Waivers For Advisory Committee Members, Including Chair

NASH Drug Coverage Issues Trigger Memories Of Hepatitis C Among Payors; ICER Panel Unimpressed By Intercept’s OCA, Sees Madrigal Agent More Favorably

Prevision Policy Clips | FDA Commissioner Califf On Lilly’s Donanemab: An “Interesting Day” For Alzheimer’s

Decentralized Trials Are Here To Stay: FDA Draft Guidance Offers Ways To Reduce Variability In Data, Affirms Agency Support For The Approach

Prevision Policy Clips | Another Beta-Amyloid Therapy Shows Clinical Benefit In Alzheimer’s: Lilly Donanemab TRAILBLAZER-ALZ 2

HELP Hearing Showcases Bipartisan Interest In Generic Competition, PBM Reforms – And Lack Of Legislative Acumen From New Leadership; Votes Postponed Pending Upcoming CEO Hearing

Prevision Policy Clips | AstraZeneca/Sanofi RSV Antibody Nirsevimab Heads To Advisory Committee June 8

Long COVID PFDD Meeting Focuses On Trial Participation Considerations; FDA Hears Significant Risk Tolerance In Comments From Patients

AZ/Merck Lynparza Headed To Narrow First-Line Prostate Cancer Label After ODAC Supports FDA Push For BRCA-Only Use

Prevision Policy Clips | FDA RFI On Patient Experience Data Kicks Off PDUFA VII Process

Prevision Policy Clips | Nonclinical Biodistribution Gene Therapies Guidance Finalized By FDA

Value-Based Purchasing For Gene Therapies, PBM Transparency Are Points Of Interest At Energy & Commerce Health Subcommittee Hearing

Prevision Policy Clips | Medicaid Payment For Gene Therapies: Energy & Commerce Health Subcommittee Chair Guthrie Highlights Proposed Legislation

ODAC To Consider Restricting First-Line Use Of Lynparza In Metastatic Prostate Cancer To Patients with BRCA Mutations; “Possible Harm” To Those Without

Alzheimer’s Coverage Expansion: CMS Envisions Light Touch For Registry Once Leqembi Is “Fully” Approved

Prevision Policy Clips | Sanders/Cassidy Release Bipartisan PBM Transparency, Drug Pricing Reform Package

Advisory Committee Tracker: Landmark Meetings On DMD (Sarepta), NASH (Intercept), RSV (Pfizer) And OTC OC (Perrigo) Highlight Blockbuster May

Prevision Policy Clips | Paul Lee Is Acting Director Of FDA’s Division Of Neurology II

Prevision Policy Clips | Insulin Manufacturer CEOs, “Top Executives” From Major PBMs Will Testify May 10 At Senate HELP Insulin Affordability Hearing