Celltrion’s Rituximab Biosimilar Gets Unanimous Support From ODAC Eight Months After CRL

AcelRx Dsuvia Sufentanil Sublingual System Appears Ready For Approval – Assuming FDA Committee Agrees REMS And Inpatient Setting Will Minimize Abuse

Prevision Policy Clips | Register now for the Biopharma Congress on Nov. 14

The New OND Panel to Feature FDA’s Peter Stein, Merck’s Sandra Milligan, Greenleaf’s John Jenkins at Biopharma Congress

“Breakthrough” Bust: Trevena IV Oliceridine Appears Less Effective Than Morphine, May Cause QT Prolongation, FDA Tells Advisory Committee

Prevision Policy Clips | Akcea/Ionis’ Tegsedi (Inotersen) Approved

Celltrion’s Rituximab Biosimilar Headed for Clean Advisory Committee Review; Sponsor Not Seeking All Indications Due To “IP and Exclusivity Landscape”

Prevision Policy Clips | FDA Advisory Committee to Discuss Opioid-Sparing Outcomes in Acute Pain Trials

FDA Real World Evidence Demos Take On COPD, Juvenile Arthritis and Inflammatory Bowel; FDA Committed To Hands-On Learning About Registry Studies

The Next Step After “Right To Try”? Senate Hearing Includes Call To Reopen The Orphan Drug Act

Prevision Policy Clips | CMS New Technology Add-On Payment “Town Hall” Set For December 4

Prevision Policy Clips | Paratek’s Big Day: FDA Approves Antibiotic Nuzyra and Acne Treatment Seysara

FDA Defines Citizen Petition Abuse: Updated Draft Guidance Notes Corporate History Can Count Against Brand Sponsors

Prevision Policy Clips | Generic-Delay Tactics: FDA Updates Citizen Petition Draft Guidance

Charcot-Marie-Tooth Disease Future Therapies Should Help Improve Mobility And Reduce Falls; Lead Candidate Is In Phase 3

Center Directors Panel: CDER's Woodcock, OCE's Pazdur, CBER's Marks At The Biopharma Congress Nov. 14

Prevision Policy Clips | Drug Labeling Bill Introduced in Senate

FDA Adapting To Adaptive Trials: New Draft Guidance Treats Concept As Proven, Useful Tool – But Cautions Sponsors Not To Rely On SPA Process For Complex Designs

Master Protocols Draft Guidance: FDA Provides Advice For Dealing With Frequent Changes That Occur With Target Cancers, Compounds And Combinations

Advisory Committee Tracker: Raising The Dead? Zelnorm Relaunch, Rethinking Diabetes Standards, NDAs Seeking To Recover From CRLs

Prevision Policy Clips | FDA Issues Draft Guidances On Adaptive Trials And Master Protocols

Pain Management Task Force Likely To Recommend Disease Management Approach For Chronic Pain; Cardiac Rehabilitation, Diabetes Are Models

Prevision Policy Clips | Epidiolex Cannabidiol Placed in Schedule V

FDA Authority Expands In Opioid Omnibus: Final Bill Means Opioid Rx Will Keep Dropping; Anti-Addiction And Non-Opioid Pain Drugs Encouraged, But Less Directly

Prevision Policy Clips | Final Opioid Bill Released