FDA Shared REMS Guidances Take Carrot-And-Stick Approach; “Benefits” Of Shared Model Emphasized – But Expect Liberal Use Of Waivers

Cassidy Healthcare Position Paper Suggests Time Is Approaching For Another “Grand Compromise” On Drug Exclusivity

Prevision Policy Clips | A New Voluntary Pricing Pledge Coming Soon?

FDA Recommends Continuous Blood Pressure Monitoring For All Chronic Use Drugs In Development In Draft Guidance

Prevision Policy Clips | FDA Guidance On Assessing Blood Pressure Effect Of Drugs

Prevision Policy Clips | Loxo Larotrectinib PDUFA Date Set for November 26

Insurers Explore New Payment Models For High-Priced Curative Therapies; New Risk-Bearing Entities, Premium-Based Fund Discussed

Prevision Policy Clips | Lifting Protected Classes In Part D, Moving B Likely Get First Political Test

Senate HELP Moves PAHPA With 22-1 Vote: Lingering Debate Over New Flu Vaccine Technologies Versus More Stockpile Purchases

Prevision Policy Clips | Toxicology Roadmap Highlighted by FDA Commissioner

Hemophilia Gene Therapy Guidance May Permit Accelerated Approval Based On Clotting Factor Levels; FDA Eager For Input On Other Specific Disease Areas For Future Guidance

Prevision Policy Clips | “Right To Try” Bill Heads To President Trump’s Desk For Signing

Insys Buvaya Pain Spray Rejected By FDA Committee: “Commendable Effort” For Less-Abusable Opioid Fails On Safety And Efficacy Grounds

Vertex “Withdraws” From ICER CF Review; NY State Review of Vertex Medicaid Pricing Changes Tone of Review; CF Foundation Cites Important Medicaid Role

Prevision Policy Clips | House To Vote On Senate "Right-To-Try" Bill Today

Merging Medicare Part B Into Part D: Arthritis Class Experience Suggests Savings May Not Be Clear Or Quick

Biosimilar Exclusivity Issues Left Behind Amid Drug Pricing Response; Litigation Rather Than Guidance Likely to Determine Key Issues, Especially For “Deemed” Products

Prevision Policy Clips | AstraZeneca's Hyperkalemia Treatment Approved

Insys Buvaya Faces Negative FDA Clinical Review Ahead Of Advisory Committee; Abuse Risk May Be Even Bigger Obstacle

Prevision Policy Clips | CMS to Part D Plans: Don’t Gag

FDA Opioid Policy Bills Head To House Floor – After Some Debate; Part B Changes For Non-Opioid Analgesics Clear Committee But Still Controversial

FDA “Name And Shame” List: Products Without A REMS May Have Most Vulnerability

Prevision Policy Clips | Lucemyra (Lofexidine) FDA Approval For Short-Term Opioid Withdrawal Symptom Treatment

CMS Opens National Coverage Analysis for CAR-Ts, MEDCAC Scheduled For August

Medicaid Drug Formulary Demo In Discussion Stages, HHS Secretary Azar Says