Prevision Policy Clips | Novartis Readying To Compete With Gilead With Kymriah sBLA in Adult Patients with Relapsed Refractory Diffuse Large B-cell Lymphoma

Braeburn Buprenorphine Injection: Novel Dosing Poses Issues For FDA, But Urgency Of Abuse Epidemic Should Carry The Day

Prevision Policy Clips | ACA Exchange Proposed Rule for 2019 Includes Intent To Pursue Future Drug Pricing Measures, More EHB Flexibility

Indivior’s Buprenorphine Injection Headed for Positive Meeting; Committee Will Weigh In On Dosing Options, REMS Details

Prevision Policy Clips | President Trump Declares Opioid Crisis National Public Health Emergency

Prevision Policy Clips | FDA Patient Focused Drug Development Workshop Announced

FDA Considering “Population-Based” Indication For Medication-Assisted Treatments; Labeling Changes Planned

Prevision Policy Clips | Bulk Drug Substances for 503A List to be discussed at Pharmacy Compounding Advisory Committee November 20

“Breakthrough” Devices Guidance Lays Out Designation Criteria; Drug/Biologic Alternatives Will Be Considered

Prevision Policy Clips | Drug-Drug Interaction Draft Guidances Announced

GDUFA II Off To A Flying Start: Wave of Approvals, Guidances and Positive Headlines; Complex Generics Meeting Showcases New Attitude

Prevision Policy Clips | GlaxoSmithKline’s Shingrix Approved by FDA

Prevision Policy Clips | White House Policy “Wish List” Includes FDA, HRSA and CMS/CMMI Objectives

FDA RSV Draft Guidance Incorporates Points From May 2016 Workshop, Reinforces Effort To Revive RSV Field

Prevision Policy Clips | Gilead/Kite’s Yescarta Becomes First FDA-Approved CAR-T Therapy For Non-Hodgkin Lymphoma

Novo’s Semaglutide Overcomes Retinopathy Concerns To Secure Approval Recommendation; CV Benefit Claim Debate Previewed

FDA’s Gottlieb Defends Accelerated Approval Pathway As Meeting Gold Standard, Watching For Access Limitations By Payors

Butrans Gets Minimal Pediatric Labeling

Prevision Policy Clips | Former HHS No. 2, Lilly Exec Azar the Choice at HHS?

Research Networks, Screening Programs Proposed For NIH/Industry Partnership On Pain and Addiction Treatments

What’s the Right Pain Population? FDA’s Hertz Reflects on Lessons of Anti-NGFs

No More Rebates? Senate HELP Chairman Alexander Says Idea Is Worth “Exploring”

Prevision Policy Clips | AstraZeneca’s Imfinzi sBLA Gets FDA Priority Review, Breakthrough Therapy Designation

Novo Nordisk’s Semaglutide: Diabetic Retinopathy Risk Gets Attention From FDA – But Efficacy, CV Safety Likely To Win Over Committee

Prevision Policy Clips | Novo’s Semaglutide: Diabetic Retinopathy Gets FDA’s Attention