Drug Pricing Complicates “Cures” In Senate; Rx Industry May Face Choice: Accept Pro-Generic Provisions, Or Wait For 2017

AstraZeneca’s Lesinurad For Gout: “Modest” Efficacy Enough To Get Positive Vote But Surrogate Endpoint Could Be An Issue

CMS Medication Therapy Management Demo Draws Bipartisan Praise; Only Issue Is Whether CMS Can Expand MTM Faster

Fluoroquinolone Safety Review: FDA Seeking Input On Whether To Cut Indications, Internal Disagreement On New Black Box

FDA Preparing For NDAs For Inhaled Antibiotics For NTM; Patient Meeting Includes Discussion Of Clinical Trial Challenges

FDA Combination Products Report Calls For Resource-Sharing Across Centers; Promising Subject For User Fee Fix?

340B Orphan Drug Exemption Ruling Opens Up Potential Area For Legislative Compromise; Marginal Positive For Sponsors

ICER Posts Draft “Scoping” Documents on Novo Nordisk’s Tresiba, GSK’s Nucala – Ahead of Nucala FDA Approval

BioMarin Drisapersen Going To Panel First And Alone; Nov. 24 Date Includes 2 Hours For Public; Sarepta Two Months Later

Repatha and Praluent Launches Earn Praise, Formulary Coverage From Express Scripts; ICER Overshadowed By PBM

“Frank” Talk On Drug Pricing: HHS Official Sees Value-Based Pricing As Area Of Common Interest

Opioid Abuse Bills: Legislative Hearing Ends Up Highlighting Executive Action On Treatment Caps, Prescribing Guidelines

FDA REMS “Platform” Model Unveiled At Public Meeting; Pilot Test Using Structured Product Labeling Is First Step

Part D “Enhanced” MTM Model: Latest CMS Demo Includes New Payments, New Strategies To Promote Rx Adherence

Alpha-1 Antitrypsin Patient Community Seeks To Push FDA, Sponsors Away From Placebo Trials For Augmentation Changes

FDA Recruiting New Biologics Center Director Ahead Of Gene, Cell Therapy Wave; Midthun Retiring At End Of Year

Trans-Pacific Partnership Deal: “At Least Five Years” Exclusivity for Biologics

Antibiotic Resistance Presidential Council Asked To Weigh In On Incentives For Rx Developers, Updates On National Plan

FDA Advisory Committee Tracker: Long-Shots Will Test Pro-Approval Climate In Final Months of 2015

Advisory Committee Trends: Panels Voting “Yes” 88% of the Time; NMEs Have Perfect Record So Far In 2015

Petitions Aren’t Delaying Approval for Many ANDAs or 505(b)(2)s, But FDA Still Concerned About Resources, Validity

FDA Turns To Novartis Exec Kopcha To Head Quality Office; Industry Perspective Adds To FDA’s New GMP Models

Anti-infective Tax Credit Proposal Would Provide “Push” Incentive for QIDP Antibiotics, Rapid Diagnostics

HHS to Lift Caps on Buprenorphine Prescribing; Timing, Process Unclear, But End Of Administration Is De Facto Deadline

Drug Pricing and Executive Action: Think Scapegoats, Not Systemic Change