Medicaid And Drug Pricing: Rebate Program Remains Key To Broader Debate, But Near Term Focus Is Federal Tweaks And State Experiments

Prevision Policy Clips | FDA "Back In Business" − But Don't Ask For Timelines

Prevision Policy Clips | Finance Committee Witness List

FDA REMS Assessment Guidance: Measure Burden Alongside Benefits Of Safety Programs; Overdue Draft Issued Amid Shutdown

MedPAC Undertaking “Broad” Review Of Drug Pricing Ideas; Commission Includes Launch Prices Among Areas That Need New Medicare Approaches

ICER Expanding Cost Effectiveness Evaluations To Existing Product Price Increases, Collaborating With NICE, Canada On New Benchmarks For Curative Products

Prevision Policy Clips | REMS Assessment Guidances Issued, But What Does It All Mean

Prevision Policy Clips | SEC Shutdown Affects Biotech IPOs

Prevision Policy Clips | White House Gets Grogan From OMB

Prevision Policy Clips | Accelerated Approval Labeling Guidance Finalized

CMS Proposes Brands Are Non-Essential When Generic Equivalent Exists For ACA Plans; Rule Ominously Asks About Reference Pricing

Part D Demo Will Test Alternatives To 80/20 Catastrophic Formula; Plans Will Have Incentive To Lower “List Prices” Of High Cost Drugs, CMS Says

Sanofi Sotagliflozin Wins Split Vote From Advisory Committee Despite Tough FDA Review: “Complete Response” May Be Next – But REMS Could Help

Prevision Policy Clips | Part D Payment Model Will Seek Lower Prices On High Cost Drugs

Rare Disease Drug Development Guidance Update Stresses Limits Of Historical Controls

Amgen Romosozumab Approval For Osteoporosis Appears Secure; How Best To Quantify Cardio Risk In Post-Market Setting Is Under Debate

Prevision Policy Clips | FDA Updates Rare Diseases Guidance, Public Meeting Coming At Some Point

Prevision Policy Clips | Mission Accomplished On IPI?

Gene Therapy Revolution Will Rely On Accelerated Approval, FDA Predicts, But Pathway Limited To Curative Therapies

FDA And Emerging Sponsors: Eighteen Companies With User-Fee Deadlines in 2019

Sanofi Sotagliflozin Faces Tough Review By Advisory Committee; Safety Profile, Composite Endpoint Both Trouble FDA And May Delay Approval

Prevision Policy Clips | Oversight Committee Hearing To Feature Academics and Patients Jan. 29

Takeda’s Uloric Likely To Stay On Market With Updated CV Labeling, Restriction To Second-Line Use After Advisory Committee Meeting

Louisiana Using Supplemental Rebates To Drive "Netflix Model" For Hep C Drugs; HRSA Must Approve 340B Approach For Prison Population

Amgen Romosozumab Advisory Committee Asked To Weigh Fracture Efficacy vs. CV Risk Of Osteoporosis Treatment; Narrowed Indication Possible