Prevision Policy Clips | FDA Oncology Center of Excellence Deputy Director Amy McKee Leaves FDA For Parexel

FDA Continuous Manufacturing Draft Guidance Offers Reassurance, Encouragement For Sponsors To Adopt New Approach

Prevision Policy Clips | FDA Issues Drug Safety Alert After Xeljanz Post-Marketing RA Trial

FLAT Prices Act Would Impose Reductions In NDA-Linked Market Exclusivities: 6-Month Cut When Annual Price Increase Hits 10%; Additional 30-Day Penalties For Further Hikes

Prevision Policy Clips | FDA Appropriations Hearing Scheduled For Feb. 27

Senate Finance Questions To Insulin Makers Show Interest in Rebate Data, Value From Product Improvements, Patient Support Programs

Karyopharm’s Selinexor Fourth-Line Multiple Myeloma Drug Faces Likely Delay As FDA Finds Issues With Single-Arm Trial Development Ahead Of ODAC

Prevision Policy Clips | Catalyst Pharmaceuticals’ Defense Of Ultra-Orphan Pricing To Sen. Sanders

CMS Trims Rx Spending Projections; Now Sees Drug Trend In Line With Overall Health Cost Growth For Next Decade—But Doesn’t Say So

Prevision Policy Clips | CBER Plans to Finalize Gene Therapy Guidances This Year on Rare Disorders, Hemophilia, Retinal Disorders, and Long Term Follow-Up

Digging Into The HHS Rebate Rule: Net Prices Will Increase For Brands In Short Term; Destabilizing Part D Is Palpable Risk

Prevision Policy Clips | The Pre-Shutdown Filing Rush May Make For A Busy Week In Mid-August

Prevision Policy Clips | House Measles Outbreak Hearing Set For Day After Pharma CEOs Testify On Drug Pricing

“Competitive Generic Therapies” Guidance Outlines When CGTs Can Get Expedited Review – and When They Can Get Exclusivity

CAR-T Proposed NCD Sets Strict On-Label, Appropriate Setting Requirements

Prevision Policy Clips | CMS Proposes Onerous Coverage With Evidence Development For CAR-Ts

Gene Therapy Payment Test Case: Massachusetts And AveXis Developing Performance-Based Annuities Pilot

Sen. Cassidy’s Formula For Gene Therapy Payment: First, Get The Price Right; Then Socialize The Costs

From PBM To ORBM? Orphan Reinsurance Benefit Managers Could Emerge To Help Finance Curative Therapies; Medicaid Rebate Rules Remain Barrier

Prevision Policy Clips | FDA Appropriations Boosted Nearly 10%

FDA Office Of Generic Drugs To Be Headed By Sally Choe: Uhl’s Successor Joins OGD At Time Of Record Approvals, Rise Of Complex Generics

DTC Tax Deductibility Joins Short-Term Congressional Options In Ways & Means Drug Pricing Hearing; Part B Inflation Rebates May Have Bipartisan Support

FDA Kicks Off Opioid Guideline Development With NASEM; “Do Not Use” List Could Be One Approach

Prevision Policy Clips | Dsuvia Approval Draws Congressional Inquiry

J&J Esketamine Breezes Through Committee: “Breakthrough” Antidepressant Will Enter Large Market; Will REMS Work Commercially?