Chemotherapy Hearing Loss Patient Meeting Reinforces FDA Interest In Otoprotectant Drugs, Strategies; PFDD Forum Has Seven Industry Sponsors

Xtandi and Erleada Pass the ICER Test But Zytiga Falls Short; Panel Questions Discounting, Length of Therapy Inputs in QALY Calculation

Prevision Policy Clips | Product Identifier Requirement Guidance Finalized

FDA Finalizes Opioid REMS; New Legislation Will Shift Focus To Packaging, Quantity Limits

Prevision Policy Clips | Opioid Response Bill: Final Version Could Ready For Votes Next Week

Alnylam’s Onpattro and Akcea’s Inotersen For Amyloidosis: High Cost Means Low Value for ICER Panel As Tensions Rise Over Price

Senate Opioid Omnibus Set For Passage: FDA Authorities Mirror House Bill, But Take Different Approach; Most Payment Provisions Are Not Included

Prevision Policy Clips | FDA Ready To Move On From CV Outcomes Study Requirements In Diabetes?

Cleveland Clinic Considering 503B Outsourcing Facility Status; Drug Shortages Are Driving Major Pharma Customers To Consider Options

FDA Floating Legislation For Diagnostics Oversight: Framework Would Exempt Most Tests From Pre-Market Review, Grandfather Already-Available LDTs

LPAD Pathway Still Uncertain, FDA Acknowledges In Antibiotic Policy Update; “Subscription” Purchase Model Still A Work In Progress

Prevision Policy Clips | Prices in DTC Ads Provision Not in HHS Appropriations Conference Report

House “Gag Clause” Bill Adds Pharmacy Benefit Education; Senate Version Ready To Pass With Biologic Patent Settlement Reporting Included

Prevision Policy Clips | Product-Specific Guidances Released

PBPK Final Guidance: Simulations For Dosing Need To Be “Discussed and Justified”

Prevision Policy Clips | Amended Gag Clause Bill to E&C Markup

Louisiana Purchase: State Rx Subscription Payment Model Will Require Federal Approval

HHS Deputy Secretary Hargan To Give Drug Pricing Priorities Keynote At Biopharma Congress

Prevision Policy Clips | Celltrion/Teva’s Rituximab Biosimilar Goes To Advisory Committee Oct. 10

Oncology R&D Requires “Outside The Box” Thinking For Preclinical Safety: New Modalities Should Not Follow Cytotoxic Model, FDA Official Says

Pfizer Bacterial Toxin Vaccines Highlighted At Research!America Forum; R&D Head Cites Close Work With FDA’s CBER

FDA Chief Counsel Cline Amin Cements Ties To Key Congressional Committees

Prevision Policy Clips | Zelnorm Reborn? US WorldMeds Application To Relaunch IBS Therapy Goes To FDA Advisory Committee

Essential Drug List For Shortages On Agenda For FDA Nov. 27 Public Hearing; ASPR Looking Ahead To New Distributed Manufacturing Solutions

Loose Lips? Pharmacy “Gag Clause” Bill Advances In House – Along With Bill To Allow CMS To Share Rebate Data With MedPAC