Clinton Rx Pricing Plan Includes $250 Copay Cap, and Plug For Hep C Cures; Silver Linings For Biopharma Amid Attacks

Democratic Pricing Policies: CAP Proposals Emphasize CER And Transparency; Candidate Clinton Likely To Follow Suit

Priority Review Vouchers: Buyers Beware! FDA Is Not Enthusiastic About Selling Faster Reviews

Senate Biosimilars Hearing: FDA, CMS Discussing “Coding Modifiers”; FDA Pushed On Interchangeability, Labeling

ICER: What Does It Actually Mean For Drug Pricing and Market Access?

Senate Bill Revives Idea Of “Platform Approvals” As Part Of “Cures” Legislation; NORD, Duchenne Advocates Back Proposal

CDER Clarifies “Breakthrough” Authority: Medical Policy Council Advises, But Review Division Decides Who Qualifies

Biosimilars Process, Progress To Get Senate Review Sept. 17; HELP Subcommittee Appears Like Safe Forum For FDA

Collegium’s Xtampza ER Clears FDA Committee; OxyContin Competitor Likely To Win FDA Approval Next Month

Sanders Drug Affordability Bill Prods Democrats To Stoke Anti-Pharma Rhetoric; Exclusivity Cuts For Fraud Violations

Purdue Avridi Oxycodone Formulation Rejected By Committee; Collegium Xtampza May Fare Better On Day 2

Payor Environment Is Major Challenge for Genetic Database Co-Developed Drug/Diagnostics

Collegium Xtampza: FDA Suggests Unit-Of-Use Packaging May Help Manage Food Effect Heading Into Advisory Committee

FDA Dispute Resolution Guidance Adds Biosimilar Applications, Clarifies When Not To Use Process

CMS VBID Model Will Test Value-Based Insurance for Five Years In Seven States; Broad Diseases Suggest Sizeable Patient Group

Purdue Avridi Heads To FDA Committee: Success Hinges On Strong Case For Unmet Need For Abuse Deterrent IR Oxycodone

HHS “Common Rule” Update Proposes One-Time Consent For Research On Bio-samples; Single IRBs Would Be New Standard

Hillary Clinton “Combatting Addiction” Initiative Includes More Access to Naloxone, Medication-Assisted Treatment

Accelerated Approval For Biomarkers? FDA Toys With Limited Context of Use Qualification As Effort To Set Standards Begins

Quality Metrics Have “High Priority” at FDA; Moving Ahead at Measured Pace, No Rush to Final Guidance

FDA Biosimilar Naming Policy: Unique Suffix For Each Product; No Surprise, But Disappointing For Payors And Some Sponsors

340B “Mega-Guidance” Sets Boundaries On Discount, Makes Big Changes For HIV Drugs, And May Signal Shift In Compliance Focus

Advisory Committee Tracker: Food For Thought On Abuse-Deterrent Formulations, No Sign of Remicade Biosimilar

FDA Workshop On Direct Oral Coagulation Tests: Focus Is Standards, Not Rolling Back Advantages Of Newer Therapies

FDAAA Trends: REMS Use Remains Low; Early Signs That Post- Market Study Requirements Easing Too