VA Review Of Sovaldi Research Is Headache For Gilead; Broader Message Is Bipartisan Appeal Of Taxpayer Rights In Price Debate

Lilly, Anthem Singing Same Tune On Value-Based Pricing, Communication Policy; Prime Prospects for CMS Pilot

The 21CC Problem: Searching for Six Democrats In The Senate

FDA Boosted By Cancer “Moonshot”: Oncology “Center of Excellence” Proposal May Fuel Broad Reorganization Push

Takeda’s Vortioxetine for Cognitive Dysfunction in MDD: Condition and Application Face FDA Committee on Feb. 3

HHS Generic Pricing Trends Report Defends FDA, Finds Big Price Increases Insignificant To Overall Value of Generics

Cancer Moonshot Task Force Gets High Visibility, But Low Impact Given Timing Of Report, Funding

GDUFA Senate Hearing: FDA Mounts Strong Defense Of Performance; Drug Pricing Debate Takes Heat Off Agency

Buprenorphine Cap Relief: Proposed Rule Coming Soon, SAMHSA Tells Senate Committee; FDA Actions Criticized

FDA Advisory Committee Tracker: Big Month For Biosimilars; Remsima Review Will Set Precedents For Humira

CDER Guidance Agenda: Additions And Subtractions For 2016

IOM Joins Drug Pricing Policy Development; Pew and CAP Moving Forward On Pricing

Wyden-Grassley “Is-Anyone-Listening?” Letter on Sovaldi Offers Further Chance to Push Premarket Transparency

CMS Medicaid Rebate Rule Leaves Line Extensions Undefined: Manufacturers Still In Limbo, But Narrower Scope Assured

CBER Director Peter Marks Has Four-Year Training for Center Top Job; Academic and Clinical Background, Stint in Industry

Senate Picking Up The Pieces From “Cures” Process; Bill-By-Bill Mark-Up Strategy Acknowledges End Of Broader Push For 2016

Sanders’ “Medicare for All” Program Comes In At $14 Trillion Over 10 Years; Platform To “Negotiate” Lower Rx Prices

GAO Report On Fast-Track, Breakthrough Highlights Gaps In FDA Post-Marketing Safety Surveillance; Key PDUFA Theme

FDA Ends DMD Panel Suspense Early: Sarepta Eteplirsen Review Is Negative On All Counts; Higher Dose May Be Path Forward

Infliximab Biosimilar FDA Ad Com Rescheduled for February 9; Celltrion Still Seeking Extrapolation to All Remicade Indications

FDA Launches Pilot Clinical Outcome Assessment Compendium; Division Breakdown Shows Pulmonary, Neurology As Leaders, Oncology Lagging

Drug Pricing Détente: State of the Union Sets Collaborative Tone But Policy Options Still on the Table

Obama’s Legacy Agenda: Curing Cancer, HIV, Malaria and Addiction – Not Capping Prices

Titan/Braeburn Probuphine Addiction Implant: FDA Panel Again Supports Approval, Clarity Still Needed on “Stable” Population

Senate Biomedical Innovation Bill Receives Acknowledgement; Califf FDA Nomination Not Out of the Woods Yet