Naloxone Availability, Access to Medication Treatment Stressed at Senate Opioid Hearing; Naloxone Pricing Questioned

Teva Asthma Biologic Faces Narrower Indication and Two Safety Issues at Dec. 9 FDA Panel Review; Good Climate Likely Prevails

FDA Seeking Clinical Data In More Diverse Patients; Large Studies May Be Needed To Better Understand Subpopulations

IND Sponsor Communication Draft Guidance Published Following 2014 Docket; Fulfills PDUFA V Commitment

FDA Panel Meetings Still Prerequisite For “At Least One” Biosimilar of Each New Reference Product

Putting Substance In “Substantial Evidence”: FDA Standards of Efficacy Take Center Stage In Panel Rejection of Gepirone

Senate Sovaldi Price Investigation Ends With A Whimper; “Transparency” Case Study Cuts Both Ways For Biopharma

PDUFA VI Update: “Breakthrough” User Fee Unlikely; FDA Focusing On Fewer Obligations Rather Than Greater Resources

FDA Advisory Committee Tracker: IMPROVE-IT Review Caps Big Year For LDL Therapies; Where Are The Biosimilars?

340B Entity Part B Earnings In 2013 Were $1.3 Billion; OIG Analyzes Changes In Part B Payment Formulas

BioMarin Drisapersen Review: Negative Votes On Clinical Evidence Likely Mean Rejection By FDA

Biosimilars Could Impact Part B Payment Formula: More Options Make Formularies More Attractive, McClellan Tells HHS Forum

Friends Of Cancer Research Proposes Joint Drug/Device Review Team Pilots; Cures/PDUFA VI Could Be Vehicles

HHS Price Forum Features New Pharma Contracting; Good Context For Proposing Regulatory Changes

BioMarin Drisapersen: Negative FDA Review Sends Clear Message That “Flexibility” Still Requires Substantial Evidence

Telesta’s MCNA for Bladder Cancer: FDA Panel Says More Studies Needed To Identify Role Of Therapy In Subpopulations

Merck CEO Frazier, Novartis US President Shaw At White House Forum: Chance To Argue For More Payment Flexibility

DEA Delays Bill Headed to President; Includes Controlled Substance European Export Provision from 21st Century Cures

HHS/CMS Internal Drug Cost Working Group Likely Looking First At Part D and Medicaid Prices, Not Part B Injectables

PBM Effectiveness As Drug Price Restraint Questioned At House Judiciary Hearing

Oncology Approvals Booming: FDA May Clear Five More Novel Cancer Therapies Before the End of the Year

House LDTs Hearing: FDA, CMS Agree on FDA Premarket Review of Lab-Developed Tests; FDA Cites Case Studies

Califf Senate Hearing: On Prices, FDA Sensitive to Monopoly Positions; On Evidence, Interested In Broader Sources

Estrogen Low-Dose Labels for VVA: FDA Needs More Evidence on Reduced Risks Before Removing Boxed Warnings

Can An Advisory Committee Salvage A Failed Development Program? Telesta’s MCNA Bladder Cancer Drug A Test Case