Save the Date - BIOPHARMA CONGRESS IV - November 14, 2018

Prevision Policy Clips | ICER To Evaluate Unsupported Drug Price Increases

PAHPA Reauth May Revive Antibiotic Incentives; Discussion Draft Reported Out of House E&C Subcommittee

CMS Says States Have To Exit Medicaid Drug Rebate Agreements To Implement Closed Formularies; State Outcomes-Based Rebate Demo Gets Green Light

HHS Secretary Azar Urges Hearings On PBM Resistance To “Voluntary” Rx Price Cuts: Immigration Debate Distracts From Drug Pricing “Blueprint” Details

Prevision Policy Clips | Genentech’s Baloxavir Flu Antiviral Granted Priority Review

Remoxy And The Future Of ADFs: FDA Still Ready To Approve New Formulations, But Where Is The “Real World” Data?

Remoxy Rejected By FDA Panel, Headed To Fourth (And Final?) “Complete Response”: Shadow Of Opana Dooms ER Oxycodone Formulation

Pediatric Oncology Molecular Target Lists: Definition Of First-In-Class, Frequency Of Updates Still Open Questions For FDA

Prevision Policy Clips | GW Pharma Epidiolex Approved, But CBD Scheduling Still TBD

Prevision Policy Clips: Gene Therapy Guidances for Retinal Disorders, Rare Diseases Planned

Remoxy Heads To Second FDA Advisory Committee With New Intranasal Abuse Study

Prevision Policy Clips | Biosimilars Analytical Similarity Guidance Withdrawn, FDA Signals Lowering Bar For Lot-to-Lot Comparisons

Prevision Policy Clips | Keytruda, Tecentriq Use Restricted in Urothelial Cancer

Non-Traditional Antibiotics Preview: FDA Engaging Publicly in Early Stages With Phages, CRISPR, MABs, and Lysins; Payment Concerns Remain A Challenge

FDA Major Depressive Disorder Guidance Updated After 40 Years; Includes Considerations For Novel “Rapid-Acting” Antidepressants

HRSA Supports 340B Legislation To Clarify Entity Use Of Drug Savings, But Does Not Provide Detailed Suggestions; 60% Of Audited Entities Owed Repayments

Prevision Policy Clips | Senate Finance Drug Pricing Hearing June 26

BARDA Continues To Feature Antibiotic Resistance Projects At House Energy & Commerce Preparedness Hearing: $1 Billion Invested Over Eight Years

FDA Sees Recent Brand Approvals As Harder To Copy As Future Generics; FDA Plans To Start Generic Research Projects Earlier For Complex Products

Prevision Policy Clips | New Generic Drug Review Platform, Drug Label Updating Initiative Coming

Prevision Policy Clips | Senate HELP Health Care Cost Hearing June 26

Prevision Policy Clips | PTO Inter Partes Review Reform A Priority For Sen. Hatch

CREATES Act Clears Judiciary Committee And Heads To Senate Floor; CBO Score Comes In Higher At $3.8 Bil. In Savings

Prevision Policy Clips | Advair Generic from Mylan Likely Delayed Until 2019 Post-CRL