MedPAC Data Dump: Medicare Drug Rebate Information Will Fuel New Analyses To Test Arguments About Impact On Premiums, Point-Of-Sale Prices

J&J COVID-19 Vaccine Booster Expected To Clear FDA Committee Despite Data Limitations; Will Second Shot Be After Two Months, Six Months (Or Both)?

Prevision Policy Clips | BIO Head As FDA Nominee? Public Citizen Thinks The Chance Is Real, Urges Biden Administration Not To Do It

Moderna Will Likely Avoid Population Pitfalls In FDA COVID-19 Vaccine Booster Review; Miss On Co-Primary Endpoint Could Cause Committee To Go Off Track

MedPAC Turns To Part B: Reference Pricing, Accelerated Approval Value Assessments Among Policy Options That May Be Pursued

Treating PML: FDA/NIH Workshop Highlights Study Population, Endpoint Choice As Major Unresolved Issues For Drug Development

Prevision Policy Clips | Genentech Alzheimer’s Drug Gets FDA “Breakthrough Therapy” Designation

Takeda’s Maribavir Antiviral For Transplant CMV Treated As Tolerability Breakthrough; FDA Committee Accepts Contribution Of Tolerability To Efficacy

Prevision Policy Clips | FDA Adds MSK Tumor Mutation Database To Public Human Genetic Variant Database

Prevision Policy Clips | Proposed Rare Disease Center Of Excellence Is Premature: CBER Director Marks, OCE Director Pazdur Say

Proposed Rare Disease Center Of Excellence Is Premature; CBER Director Marks, OCE Director Pazdur Say Necessary Science, People Not Yet In Place

Lessons Learned From COVID EUAs: FDA Center Directors Say Statute Is Sound, But Want More Disclosure Authority; Device Center Response Plays Better To NAM Audience Than CBER Or CDER

Prevision Policy Clips | Drug Payment Models Ready To Go “If The Time Is Right,” But Still Waiting For Congress

Takeda Antiviral Maribavir: FDA Concerns About Pivotal Trial May Mean Narrow Indication For CMV; Unmet Need Should Win Approval Vote

Prevision Policy Clips | NIH Director Collins’ Departure Could Have Ripple Effects On Drug Pricing Debate

Prevision Policy Clips | Trick Or Treat: With CBER Director Marks In Charge, October Dates Set For Pediatric, Moderna/J&J Booster Advisory Committee Reviews

Can Too Costly Still Be A Good Deal? ICER Panel Weighs Argenx Pricing Plan For Pending Myasthenia Gravis Therapy Efgartigimod Versus Alexion’s Soliris

Putting The Placebo In Placebo-Control: Rough Lessons Learned From COVID-19 Therapeutic Development; FDA Explains HHS/DoD Learnings Document To RUF (Reagan-Udall Foundation)

Prevision Policy Clips | Patent-Themed Four-Pack Of Drug Pricing Bills Ready For Full House Consideration

Advisory Committee Tracker: Oncology Accelerated Approval Reviews Continue Into Fall; Can Oncopeptides Save Pepaxto?

Gene Therapy Umbrella Trials: Guidance Lays Out IND Structure For Early Studies Of Multiple Product Versions With Examples

Prevision Policy Clips | Anti-“Product Hopping” Legislation Is Most Controversial Of Three Drug Pricing-Related Bills, But Passes House Judiciary Committee

FDA Benefit-Risk Assessment Is Based On Overall Population – Not Tolerance Of Individual Patients, Agency Says In New Guidance On Core Regulatory Actions

Pulmonary NTM Drug Developers Should Not Depend On “Microbiological Endpoints” For Primary Efficacy Claim, FDA Says In Draft Guidance

Prevision Policy Clips | Gene/Cell Therapy Guidance Describes Regulatory Framework For Early Studies