CBO Rebate Rule Medicare Cost Projections Are Less Than CMS, But Confirm High Costs Of Dropping Rebates

Prevision Policy Clips | Pediatric ODAC Meeting, ADHD Drug Development Guidance, And House Tackles Drug Prices May 9

MedPAC “Drug Value Program” Gets Favorable Response During House Hearing As Alternative To International Pricing Index In Medicare Part B

Prevision Policy Clips | CBO Single-Payer Primer Includes Administered Pricing

Advisory Committee Tracker: ODAC Is Back With Daiichi Sankyo Facing An Unusual Back-to-Back Review

Common Themes In Rare Disease: FDA Workshop Brings Input On Novel Endpoints, Trial Design Considerations That Cut Across Orphan Indications

Bacitracin IV Likely To Be Withdrawn In “Unusual” Case Following Overwhelming Vote By FDA Panel On Negative Risk/Benefit Profile

CREATES, Pay for Delay, and “Sham” Citizen Petition Bills Pass House Judiciary Committee; FTC Study On PBM Practices Rides Along With Drug Pricing Package

Prevision Policy Clips | FDA Workshop For Adenoviral Infection Drug Development

Tissue-Agnostic Cancer Drug Development: First Approvals Show FDA Flexibility, But Still More Questions Than Answers On Pathway

Medicare Part D Out-Of-Pocket Cap Has Bipartisan Support In House E&C Hearing; MedPAC Testifies For Broader Reform Of Catastrophic Coverage

Prevision Policy Clips | AbbVie Wins Washington State Hep C "Netflix-Like" Bid

Gene Therapy Durability: Challenges For Long-Term Safety And Outcomes Assessments Posed By Highly Effective One-Time Treatments

Prevision Policy Clips | MedPAC Exec Director Mathews Will Testify At Medicare B And D Drug Pricing Hearing

Antimicrobial Drugs Panel Endorses FDA Approach To MAbs-For-Rabies Development Program, With Reservations About Recruitment

Prevision Policy Clips | Opioid Dose Limits: Role Of Higher Doses Will Be Advisory Committee Topic June 11-12

Pazdur Unleashed: FDA Oncology Head Having “Fun” In Provocative PD-1 Session; Is A Class Label For Checkpoint Inhibitors A Natural Progression?

Prevision Policy Clips | Lilly Withdrawing Lartruvo After Failed Confirmatory Trial

NTAP Class Of 2020: J&J Has Three Candidates For Hospital Add-On Payment, Including Esketamine; Eight More Biopharma Products In Line As Well

NTAP “Breakthrough”: FDA-Designated Devices Would Qualify For Add-On Status Under CMS Proposal – But Not Drugs, Given Pricing Concerns

CMS Proposing Higher Payment For NTAP Products In 2020; CAR-Ts Are Primary Focus, But Andexxa Could Be A Big Winner

Prevision Policy Clips | Medicare Part B and D Drug Payment Subject Of E&C Hearing

MAbs For Rabies: FDA Asks Antimicrobial Drugs Panel To Advise On Novel Approach To Development; Tropical PRV In Play

FDA Appears Ready To Work On New Assessment Tools For NTM Disease; Insmed’s Lessons Learned From Arikayce Highlight Need

Mitochondrial Disorder PFDD Alerts FDA To Need For “Better Day” Definition; Future Treatments Complicated By Wide Range Of Vitamin/Supplement Use