340B Cuts Will Expand In 2019 Under Proposed Rule; Exparel Doing Fine In Bundle, CMS Says – But Will Be Carved Out In ASCs

Part B Competitive Bidding Demo Floated: Re-Inventing CAP As “VAPA” – With Value Focus, Potential Inclusion of Medicaid

GSK Nucala For COPD Turned Down By FDA Advisory Committee; Phase III Trials Undercut By Trying To Do Too Much

Prevision Policy Clips | CMS Seeks Ideas For Reviving Competitive Bidding Program In Part B, Proposes To Expand 340B Payment Cut

New Focus For FDA Competition Efforts: Incentives For Second And Third Entrants In Specialty Drug Classes; “Cures” Hearing Testimony Shifts Focus From Unmet Need

Biologics Patent Settlement Reporting Provision Added To Pharmacy “Gag Clause” Bill Heading To Senate Floor

CMS Policy On “Indication-Based Utilization Management” Points Towards Indication-Based Pricing – And Shows More Activist Pricing Tone At Medicare Agency

Prevision Policy Clips | CMS Staffs Up: New Principal Deputy Paul Mango

FDA Biosimilars Hearing In September Seeks To Flesh Out Ideas In Action Plan; Evergreening And “Umbrella Exclusivity” Among Key Topics

Prevision Policy Clips | FDA Sets Part 15 Hearing Date For Ideas To Enhance Biosimilar Competition

GSK Nucala COPD Indication Lacks Replicated Trial Support and Is Based On Unconfirmed Mechanism Of Action, FDA Says In Advisory Committee Preview

Prevision Policy Clips | GSK’s Tafenoquine Approved; 60 Degrees Pharma’s Product To Adcomm This Week

FDA Encouraging Companies to Submit Cross-Labeling Applications for Oncology Products: To Reduce Checkpoint Jam And To Help Bring Older Oncology Product Labeling Up To Date

Prevision Policy Clips | Merck “Responsible Pricing” Statement Features 60% Cut To List On Zepatier, Draws Praise From HHS Secretary

FDA To Explore “Temporary, Narrow” Importation To Address Drug Price Spikes Aimed At Off-Patent Price Outliers; Longer Term Implications Could Be Much Broader

FDA Commissioner Office Reorg: Center Directors Will Report Directly To Gottlieb; “Flattened” Structure Intended To Make Future Political Transitions Easier

Prevision Policy Clips | Rebate Reform Rule Coming Soon

FDA Biosimilar Action Plan Does Not Break New Ground: Agency Points To FTC, Medicare Changes As Key; Interchangeability Not Emphasized

First Principles For Real World Evidence: FDA Final Guidance On EHR Use Emphasizes Need To Cite “Data Originator”

Prevision Policy Clips | FDA Finalizes Biosimilar Labeling Guidance As It Prepares For “Action Plan”

FDA Restarts Path Toward NSURE: Draft Guidance Invites Sponsors To Submit Apps, Videos With OTC NDAs

NIH Keeps Close To FDA On Nanoparticle and Prototype-Pathogen Influenza Vaccines; Counting On Familiarity To Shorten Regulatory Reviews

FDA Taking Active Role On Localized Prostate Cancer Trial Design; Floats “Prevent/Delay” Model For Studies In Early-Stage Population

Prevision Policy Clips | Next Step For “Wildcard” Patent Bill Comes In House Mark-Up

Prevision Policy Clips | SIGA Smallpox Drug Awarded First Medical Countermeasure PRV