Prelaunch Problems: “Cancer MoonShot 2020” Initiative Unrelated to VP Biden Plan Expected In State of the Union

Titan/Braeburn Probuphine Implant Returns to FDA Committee; Key Issue Is Narrower Target Population For Addiction Therapy

IG Letters Flesh Out New Rules For Patient Assistance Programs

ICER Draft Reports: 25% Of New Drugs Studied Are Cost-Effective; GSK’s Nucala and Novo’s Tresiba Are Latest Test Cases

FDA Advisory Committee Trends 2015: Panels Voted “Yes” 78% of the Time, 83% for NMEs; FDA Actions Usually Consistent

CMS 2014 Drug Expense Dashboard Uses Transparency, Avoids Part D Rebates; 13 Products Cost More Than $50,000 Per Patient

FDA Innovative Manufacturing Process Review Program Will Offer Sponsors Early Feedback On New Technologies

FDA “Fixed Dose” Proposed Rule Outlines Alternatives To Factorial Study Designs, Including Waiver Process

FDA Advisory Committee Tracker: Round Two On DMD; Sarepta Unlikely To Fare Better Than BioMarin

BsUFA II Kick-Off: FDA Wants to Revisit Workload Assumptions: More Meetings, Fewer Applications Than Expected

Medicaid Inflation Rebate Would Have Raised At Least $1.4 Bil. Over Past 10 Years, OIG Report Says

CMS Final Rule on Line Extension Rebates and AMP In Medicaid Clears OMB

CDC to Get $70 Million for an Opioid Overdose Prevention Program; CDER $355 Million in Budget Authority in Omnibus Bill

21st Century Cures: Gone? Or Gone Elsewhere? Omnibus NIH Funding Likely Spells End of Senate Legislative Push

Congress Requests HHS Drug Price Report In Omnibus; Topics, Limitations, And Timing Work Well For Brand Companies

FDA’s Strategic Retreat On Pacira Case: Concedes On Broader Use of Exparel; But Gets Firm To Play By sNDA Rules

“Breakthrough” Transparency? Europe’s PRIME Could Offer “Backdoor” Insight Into FDA Designation Decisions

FDA’s Big NDA/BLA Approval Total Has Room To Grow; 42 NMEs To Date, Two Dozen Applications Still Pending

Merck IMPROVE-IT Claim Rejected By Panel, But May Still End Up In Label; FDA Faces Tough Challenge Given Califf’s Role

Advisory Committee Recommends Contraindicating Rx Codeine for Cough, Pain in Children, Removal from OTC Monograph

Room To Improve? Panel Review of Vytorin Outcome Claim Should Go Well For Merck, Leave Room For New LDL Therapies

Teva Cinqair Asthma Biologic Gets Strong Okay From FDA Panel For Adults; FDA Faces Negative Adolescent Vote Again

Let The Scapegoating Begin: Senate Price Hearing Focuses On Safe Themes For Innovators—But Tougher Ones For Generics

Phase 1 and Done: FDA Wary Of Ever-Expanding First-in-Human Trials; Breakthrough Pace Okay, But Protocols Must Be Clear

FDA Advisory Committees in Cancer: The “Pazdur Criteria”