Prevision Policy Clips | FDA Exploring Limiting Risks in DTC Advertising to Severe, Serious or Actionable

Delay, Delay, Delay: 340B Ceiling Price Final Rule Effective Date Proposed For July 2018; HHS Signals More Pro-Biopharma Rulemaking

Cardiac Rehab Demo Rescinded, Part B Drug Payment Model Still Breathing?

Prevision Policy Clips | Bayer’s Baycol Tablets Approval Withdrawal by FDA

Prevision Policy Clips | HHS Inspector General Work Plan Update

Opioid Emergency Designation Could Permit Manufacturer Contracts, Stockpiling To Increase Access To Naloxone

Prevision Policy Clips | Purdue’s Butrans sNDA for Pediatric Indication Advisory Committee September 14

Prevision Policy Clips | Merck CEO Frazier Resigns From Trump’s American Manufacturing Council

Prevision Policy Clips | President Trump to Declare Opioid Crisis a “National Emergency”

Prevision Policy Clips | CAR-T Therapies ICER Scoping Document Posted

Zinplava and Stelara Get New Technology Add-On Payments; Blincyto NTAP Expires As Kite Withdraws Request For CAR-T

Prevision Policy Clips | FDA Generic Competition Working Group Created

Weekly Highlights: July 31-August 4

Pfizer’s Xeljanz Psoriatic Arthritis FDA Approval Likely; AdComm Questions Proposed Claim On Radiographic Progression

Right-To-Try Clears Senate; Modified Bill Assures Drugs Are Under FDA Purview – More Work For FDA, Not More Control

FDARA Clears Senate, With Right-To-Try On Separate Track; “Clean” User Fee Bill Still Adds To FDA To-Do List

Janssen/GSK Plivensia Safety Concerns Outweigh Efficacy: Death Imbalance, Lab Abnormalities Lead to Advisory Committee Rejection

HHS Deputy Team Clears Senate Committee; Preparedness, Opioid Response Are Key Themes – As Is Industry Partnership

Weekly Highlights: July 28-24

Pfizer Xeljanz For Psoriatic Arthritis: FDA Sees No New Safety Signals – But Radiographic Progression Efficacy Claim Unlikely

Part B Drug Spending: Gap Between Hospital And Physician Growth Rates Narrows In 2015; Eyelea Is Now Largest Line Item

White House Opioid Report: Greater Access To Addiction Treatment Urged; Support For Mandatory Prescriber Education

J&J/GSK Plivensia IL-6 Antibody For RA Faces Questions About Imbalance In Deaths; FDA Skeptical Of Dose, Maybe More Than Safety

FDA Advisory Committee Tracker: ODAC Winning Streak Continues; FDA Could Reach 40 NMEs Again In 2017

Dynavax Heplisav B Vaccine Clears Safety Hurdle At FDA Advisory Committee; Stronger Post-Market Study Needed For Approval