Prevision Policy Clips | Aduhelm Price Cut Prompts HHS To Re-Evaluate Part B Premium Increase With Coverage Policy Imminent

RMAT Expedited Designation Showing Appeal To AAV Gene Therapy Development Projects: Grounding In Clinical Benefit And Range Of Post-Market Alternatives Appear Well-Suited

Prevision Policy Clips | OCE Takes Capability Of Sponsors To Complete Confirmatory Trials Into Accelerated Approval Decisions, FDA Chief Of Medical Oncology Julia Beaver

Part D Point-Of-Sale Pricing Rule Would Save Manufacturers Almost $15 Billion Over 10 Years; CMS Starts With Pharmacy Payments To Lower Beneficiary Costs, Not Rebates

Prevision Policy Clips | Part D “Pharmacy Rebate” Rule Would Save Manufacturers Almost $15 Billion

Prevision Policy Clips | Lilly's Tirzepatide Would Be Cost-Effective If Priced Between $5,500 and $5,700

FDA Advisory Committee Trends: Non-COVID Meetings Are Very Rare – And Very Negative – In 2021

Prevision Policy Clips | Omicron Halts FDA Domestic Inspections, Further Delays Foreign Inspections

Advisory Committee Tracker: ODAC Tackles China-Only Trials In Upcoming Review Of Lilly/Innovent PD-1 Inhibitor; ALS Meeting Looms For Spring

Omicron-Specific Vaccine May Be Unnecessary, But “We’ll Be Ready,” FDA Says

Prevision Policy Clips | FDA Commissioner Nominee Robert Califf To Get Senate HELP Committee Vote January 5

Prevision Policy Clips | 50 NMEs Again: FDA Approval Of Leo Pharma Adbry December 27

Prevision Policy Clips | Pfizer Paxlovid Authorized By FDA, While Merck’s Molnupiravir Still Awaits Decision

Drug Price Debate In 2022: Could A Bipartisan Bill Be Enacted?

FDA “Virtual” Trials Guidance Outlines Importance of Verification/Validation Of Digital Health Tools

Prevision Policy Clips | “Virtual” Trials Take A Step Forward With FDA Draft Guidance

NTAP Class Of 2023: CMS Asks Companies To Help Triage New Technology Payment Reviews By Flagging Products That Won’t Clear FDA In Time

Prevision Policy Clips | FDA Final Guidance For Biologic CMC Manufacturing Minor Postapproval Changes

Prevision Policy Clips | Drug Pricing Bill In Jeopardy: Sen. Manchin Says “No” To Build Back Better Act

Prevision Policy Clips | Pazdur Says “Dangling”/Delinquent Accelerated Approval FDA Panel Reviews To Be Routine

Accelerated Approval Arm Twisting: OCE’s Pazdur On How He Gets Results When He Goes After “Dangling” Or “Delinquent” AAs – And Says More To Come

China-Only Oncology Studies Are “Problematic,” FDA’s Pazdur Says Ahead Of Landmark Review For Lilly/Innovent PD-1 Inhibitor; Diversity Is Overarching Goal

Prevision Policy Clips | FDA Wants To Rein In “Wild West” Of Checkpoint Inhibitor Development: Efforts To “Corral Enthusiasm”

Prevision Policy Clips | FDA Commissioner Nominee Robert Califf Commits To Prioritize Opioids, Pandemic Preparedness If Confirmed

Real World Issues Compete With Real World Evidence On Califf’s Agenda; Confirmation Hearing Goes Smoothly, But Opioids, COVID Come First