Senate User Fee Bill Moving Quickly; Small Changes to Floor Version for Smooth Process

HIV Drug Price Hearing: Witnesses Preaching to a Very Small Choir, But Prize Proposal Worth Watching

CBO Score Out for Senate User Fee Bill

Biosimilars: Abbott Makes Waves With Real Challenge To Pathway At FDA Meeting

Gilead “Quad” HIV Therapy Clears FDA Committee, On Track For Approval; Pricing Pushback Could Be Longer Term Issue

Gilead Truvada HIV Prophylaxis Use For Uninfected Approved At Committee: REMS Refinement Necessary

Arena’s Lorqess Gets a Yes But Immediate Approval Unlikely; Vivus on Track for July Approval

User Fee Bill Passes Full Energy & Commerce Committee; Members Continue Work on Track-and-Trace Provision

Pfizer’s Tofacitinib in RA: It’s All About the Dose as FDA Panel Votes To Recommend Approval

Gilead’s Quad HIV Therapy On Track for Positive Panel Vote; Discussion to Focus on Post-Market Renal Safety Monitoring

Regeneron Arcalyst Gout Indication Rejected at Committee: Patient Population Too Broad; Safety Studies Too Short

FDA Describes Positive Environment for Gilead Truvada Pre-Exposure Prophylaxis Advisory Committee Review

Quick Energy & Commerce Health Subcommittee Markup Furthers Speedy Reauthorization Process

Arena’s Lorqess Returns to Committee: CV Outcomes Standard Likely to be Applied to Weight Loss Agent

Three-Month Review Extensions Tick Upward: Marqibo Latest Example

IOM Post-Market Study Report Sets Model for Life-Cycle Benefit-Risk: Not a Solution for 2012 But an Option for FDA’s Next Safety Crisis

Pfizer’s Tofacitinib in RA: Difficult Panel Coming As Malignancy Risk Appears Key To Up or Down Vote

House UFA Draft Update

FDA Seeking Input on REMS Assessments: Improving Surveys to Measure Patient and Provider Understanding

White House Bioeconomy Report Includes Coverage With Evidence Development

Regulatory Landscape for Obesity Drugs: A Path Forward is Taking Shape

Advisory Committee Tracker: A Big Month For Pfizer, But No Apixaban Panel After All

Line-Extension Rebate: CMS Proposal Draws Broad—But Not United—Opposition From Industry

Senate User Fee Markup Goes Smoothly; House Delays

Iressa (AstraZeneca) and Oforta (Sanofi) Accelerated Approval Withdrawals: Actions Reaffirm AA Process