Achondroplasia Clinical Study Review By FDA Advisory Committee: Does Snow-Delay Mean No-Delay For Biomarin Vosoritide Program?

Prevision Policy Clips | Novartis to Acquire AveXis

Vertex’ Orkambi Triggers NY Medicaid Drug Price Law As First Test Case In Public Utilization Review, Supplemental Rebates Recommendation

Prevision Policy Clips | Incyte's Epacadostat Combo with Keytruda Fails in Late-Stage Melanoma Study

Prevision Policy Clips | Energy & Commerce Health Subcommittee to Discuss 34 Medicare- and Medicaid-Related Opioid Bills April 11

Part D and Opioids: CMS Finalizes 7-Day Supply Limit, Implements “Lock-In” Program

FDA’s Gottlieb Favorable On House “Right-To-Try” Legislation: Patient Protections, Agency Oversight Are Important Tweaks

PBM Consolidation: Implications For Medicare And Drug Pricing Policy

FDA Proposes Broader Public Visibility For Benefit-Risk Assessments; Hints At Potential For Quantitative Approaches

Prevision Policy Clips | Liposome Drug Product Final Guidance

CDER Web Portal For Stakeholder Meeting Requests Well Received By Patient Advocates; Meetings Scheduled Within A Few Months

CMS Puts Off Rebate Pass-Through In Part D; Separate Rule Could Be Showcase Event – And Leverage To Encourage More Plans To Act On Their Own

Genentech’s Hemlibra: When Less Is Still Too Much; ICER Review Finds Lower Cost, Better QoL Versus High Cost Segment Of Hemophilia Care

Prevision Policy Clips | CMS Finalizes Part D “Call Letter,” Defers Action On Rebate Pass-Through

Advisory Committee Tracker: Spring Schedule Is Filling Up, With Baricitinib And Celebrex Cardiovascular Safety Among Highlights

Prevision Policy Clips | Alkermes Hits The Limit Of FDA’s Flexibility: “Refuse-to-File” Letter

Prevision Policy Clips | CVSHealth’s Daniel Best Is HHS Senior Advisor on Drug Pricing, Assistant Secretary for Health Brett Giroir Will Head Opioid Policy

FDA Push For Biosimilars: Tightening Biologic Manufacturing “Drift” Is Among Dozen Coming Policies To Drive Investment

Prevision Policy Clips | NIH Director Francis Collins to Testify at Appropriations Committee Hearing April 11

US WorldMeds Lucemyra (Lofexidine) Gets FDA Advisory Committee Okay for Mitigation of Opioid Withdrawal Symptoms; Lower Dose Urged By Committee

Prevision Policy Clips | Insys Buprenorphine Sublingual Spray Advisory Committee Meeting

Prevision Policy Clips | Senate Opioid Discussion Drafts Address Areas of Interest for FDA

Combination Products: FDA Delays FAERS Reporting Compliance By One Year; Draft Guidance Includes Specific Examples

Prevision Policy Clips | ICER Final Report on CAR-T Therapies Calls for Changes to Ensure Affordability and Access

Compounding Guidance Puts Drug Approval Process and Approved Products First, Sets Narrow Parameters Around Bulk Substances For Outsourcing Facility Compounding