FDA Combo Exclusivity Policy: Federal Court To Review Whether Older Products Should Qualify For 5 Years

Drug Pricing Hearing May Refocus Activity On Restricted Distribution; Scapegoating Gets Sharper As Probe Continues

FDA “Intercenter Institutes” Legislation Headed For Senate Mark-Up; FDA Would Test Concept In At Least One Disease Area

340B Program In Drug Pricing Hearing: Turing Complaints May Undercut Broader Industry Effort To Rein In Discount

Is Part D Bundling An Answer To Rx Prices? CMS’ Cavanaugh Says Risk Sharing, Value-Based Outcomes Are Less “Complex”

March-In Rights, Cancer Moonshot Featured At House Hearing On NIH Budget

GLP-1/Insulin Combos Head To Committee: Test Of Current FDA Attitude On CV Outcomes, Priority Review Vouchers

Rx And Addiction: Political Climate Favors Treatments, But Putting Brakes On Opioids For Pain

Indication-Specific Pricing: ICER Recommends Against Starting With Part B; “Weighted-Average” Approach Easiest For US

Generic Priorities: FDA To Expedite “Sole Source” Competition; Senate Bill Would Use Vouchers As Incentive For ANDAs

FDA Qualifies Second Patient Reported Outcome Tool for COPD; Five Years Coming, FDA Guidance Notes Further Work Needed

NDAed Biologics: Products Transferred to BLAs Won’t Get New Exclusivity; Sponsors of Proteins Should Consider BLAs Now

Vaccine “Purchase-For-Access” Model May Be Option For High-Cost Drugs Like Hep C, Ex-FDA Deputy Sharfstein Says

Voucher Day at Senate Innovation Markup: Seven Bills, Three Review Vouchers; NIH Funding Remains Roadblock Ahead

Compounding Complexity: Split FDA Committee Vote On Quinacrine; Inhalers To Go On “Difficult to Compound” List

The Future of Part B: Value-Based Pricing Options Range From Intriguing To Ominous; Time To Merge Into Part D?

FDA Restructuring: “Range Of Options” For Medical Product Consolidation; Companion Diagnostics May Be Starting Point

CMS Part B Payment Demo: New 102%+$16.80 Formula; Phase II With Range of Value-Based Options, Reference Pricing

Amarin Settlement Assures Vascepa Off-Label Claims; FDA Ties Court Order To One Product But Off-Label Precedent Edges On

FDA Adjusts To Immunotherapy Reviews at CDER and CBER: High Response Rates Create New Hurdles

CMS “Retail” Insurance Model: How Prescription Drugs Fit In

Senate HELP Chair Keeps Hope Alive For Standalone Cures Bill In 2016

FDA Narrows Acceptable Sources for Fetal Microbiota for Transplantation to Treat C. Difficile

FDA Science Board Meeting Discusses How Best to Treat Pain; May Advisory Committee Will Look at ER/LA Opioid REMS

Califf Commits to Use Opioid Advisory Committees More; Tells Senate He Would Have Had Two Zohydro Public Reviews