Prevision Policy Clips | 340B Ceiling Price Rule Will Be Delayed Another Year

First LPAD Crashes on Launch Pad: Achaogen’s Plazomicin Recommended For cUTI Indication But Not Precedent-Setting Blood Stream Infection

The End of Rebates? HHS Considers Ending “Safe Harbor” As Part Of Pricing Plan; FDA Role Will Include Guidance To Address REMS Abuse, Exclusivity “Parking”

Prevision Policy Clips | Sandoz Rituximab Biosimilar Receives "Complete Response" Letter From FDA

Prevision Policy Clips | Kymriah Gets Second FDA Approval, CMS Still Mum On Outcomes Models

Mallinckrodt’s Pediatric Jaundice Drug Stannsoporfin: Approval Depends On REMS – If Committee Can Get There

Advisory Committee Tracker: Where Are The Biosimilars?

Prevision Policy Clips | HHS Pain Management Task Force Inaugural Meeting Set For May 30-31

Achaogen Plazomicin Will Test LPAD Antibiotic Pathway: How Limiting Will “Limited Population” Labeling Be?

Pediatric Cancer Relevant Molecular Target Lists From FDA Advancing On Pace For August Deadline: More Concerns About Meaning Than Specific Targets

FDA Support For De-Risking Change To Continuous Manufacturing Gets Attention In Congressional, Policy Forums; Lilly’s Verzenio Is CM Regulatory Success Story

Opioid Legislation: First Bills Move Through Mark-Up, But A Lot Of Changes Still To Come; OTC Monograph Reform, Animal Drug Fees May Ride Along

Prevision Policy Clips | Spark Sells PRV for $110 Mil. to Jazz

FDA Office of New Drugs Reorg Will Create More Review Divisions; Create Openings For New Generation Managers; Unsettle Staff

Prevision Policy Clips | New York State Medicaid Board Recommends Supplemental Rebate for Vertex’ Orkambi

NTAP Scorecard: Achaogen, Melinta Will Test Climate For Add-On Antibiotic Payments Under Trump; Portola, Progenics Need FDA To Act First

Prevision Policy Clips | E&C Health Subcommittee Reports Out 56 Opioid Bills, ADUFA Reauthorization

The End Of The COX-2 Debate? PRECISION Trial Will Get In Celebrex Label As FDA Panel Votes In Favor Of Relative CV Safety

CAR-T Payment Policy: Kymriah, Yescarta May Get New Code Rather Than Add-On Payment; CMS Treats CAR-Ts As Single Class

FDA Plans “Structured” ANDA To Accelerate Generic Reviews; Budget Would Fund Labeling Updates, Includes $100 Million For Real World Evidence Effort

ODE II Director Curtis Rosebraugh to Retire at End of April, Creating Three Leadership Vacancies in One Review Office

Prevision Policy Clips | CMS Considering Separate Payment for CAR-Ts Rather Than “Add-On” Payment

Lilly Back To Square Two (2 mg, That Is) For Baricitinib: FDA Committee Says Lower Dose Has Better Benefit-Risk Than Lilly-Preferred 4 mg

Prevision Policy Clips | FDA’s Knowledge Management System: The Digital Bob Temple?

Prevision Policy Clips | Pfizer Herceptin Biosimilar Receives "Complete Response" Letter From FDA