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

FDA’s Sentinel Strategy: Starting Slow Move Toward “Active” Surveillance; Signal Detection Pilots Will Start In 2019, Take Many Years

Prevision Policy Clips | Nabriva's Contepo PDUFA Date Moves Up Two Months

Prevision Policy Clips | House Oversight Drug Pricing Hearing Will Precede Michael Cohen Testimony

Prevision Policy Clips | Drug Pricing Bills: Same Schtick, Different Day

Takeda’s Uloric: FDA Panel Will Include Previous High-Profile Drug Safety Figures (Nissen and Psaty) As FDA Considers CARES CV Outcomes Trial

Accelerated Approval Trends At FDA: New Uses For Marketed Drugs Drive Recent Use Of Pathway

Prevision Policy Clips | FDA Shutdown Needs To End Soon, Or Biopharma Industry Will Start To Feel The Pain

California Medicaid Could Be New Center For Drug Pricing Reform If Democrats Win White House In 2020

FDA Office Of Drug Evaluation Sciences Is Formally Unveiled; FDA’s Efforts To Stimulate Innovation Are Working – But Stimulating Biotech Investment Is Not