Weekly Highlights: June 27-July 1

Presidential Council Discusses Antibiotic Incentives; But Administration Not Ready To Bring Forward

Oncology Launch Prices, NIH Clinical Trials Blasted By VP Biden; Cancer “Moonshot” Initiative Needs To Effect “Culture Change”

FDA Oncology “Center of Excellence” Will Be Led By Pazdur; Structure Of Cross-Center Collaboration Will “Evolve” Over Time

BI Adapts To Complicated CV/Diabetes Regulatory Review: Edges Out 12-11 Yes Vote For Jardiance From FDA Committee

Part B Demo Will Change, But CMS Signals It Will Move Forward

IPAB Trigger More Certain In 2017; Next HHS Secretary Could Recommend Savings Beyond Target Overlap

BI/Lilly Jardiance Impresses FDA On CV Death; Sponsor Narrows Indication, Appears Headed for Panel Okay June 28

Weekly Highlights: June 20-24

HHS 2015 Part D High-Spend Report Emphasizes Compounded Topicals; Opioids Exceed $4 Billion, But Upward Curve Slows

Senate CREATES Act Would Address Brand REMS Blocking Tactics; Judiciary Hearing Showcases Bipartisan Support

Xtandi “March-In” Petition Rejected As NIH Uses “In Short Supply” Standard – Not Price

Former CMS Principal Deputy Administrator Blum Has Advice For Phase II Of Part B Demo: Build Physician/Patient Coalition

FDA Drafting Guidance On “Non-Traditional” Trials; Oncology Group Moving Forward On “Real-World Evidence”

Real-World Tests Of “Real-World Evidence”: PD1 In MSI-High Tumor Types May Be First Example

FDA Peripheral Neuropathic Pain Treatment Strategies and Improvement Sought in FDA Patient-Focused Drug Development Meeting

Weekly Highlights: June 13-17

FDA Oncology Product Review Consolidation Announcement Coming Soon

House “Superbug” Hearing: Antibiotic Resistance in Headlines Again, Limited Population Pathway Still Not Law

Humira Biosimilar Heads to Committee; Amgen Seeks Major Indications, Avoids Three Orphan-Protected Indications

OTC User Fees Supported By Stakeholders, But Industry Wants FDA Overhaul Of Monograph Program, Exclusivity For New Data

Weekly Highlights: June 6-10

Merck Bezlotoxumab Wins On Preferred Indication: Prevention of C. Diff. Recurrence Clears FDA Committee 10-5

Senate Finance Committee Part B Demo Hearing Likely To Show How Far Democrats Are Willing To Go

Sandoz Enbrel Biosimilar Heads To Committee; Approval Likely Before End Of Summer, Launch Depends On Patent Fight