Infliximab Biosimilar Approval: Taking Stock At an Important Milestone

President’s Antibiotic Advisory Council Accepts Draft Report for HHS; Development Incentives, Encouraging Rapid Diagnostics Are Themes

Intercept’s OCA Goes To Committee: FDA Analysis Should Help Sponsor Justify Surrogate Endpoint For Accelerated Approval

CMS Final Part D Call Letter: Watchful Waiting On Drug Prices

Limited Use Pathway Bill For Senate Markup Ties Program More Firmly To Antibacterials; Narrow “PATH” For Other Uses

ClinicalTrials.Gov Compliance Is New Theme In Senate Innovation Bills; Data Sharing Language Also Added

HHS Proposes New Tier of Buprenorphine Caps; Obama “May Have to Take a Look at” Mandatory Prescriber Education

CMS Risk Adjustment Rx Drug Data Models Include Better Access As Key Benefit But Gaming A Concern

Weekly Highlights: March 28-April 1

FDA’s Message To Patient Advocates: Efforts On Engagement Are Only The Beginning

Biosimilar Labels Will Be Highly Similar: Originator/Copy Will Share Clinical Data; FDA Issues Biosimilar Labeling Guidance

PATH Antibiotic Approval Pathway Gets Into Senate Queue, With FDA Hiring, Intercenter Institutes; April 6 Exec Session Set

Acadia Nuplazid Parkinson’s Psychosis Drug Survives One Negative FDA Review; Label Issues Include Class Warning

Target Validation Highlighted For Collaborative Appeal By Biopharma Sponsors At NAS Genetic Bioresource Workshop

Astellas/Medivation Xtandi March-In Pressure Has 2004 Precedent; Abbott Norvir Faced Perfunctory Hearing, No Action

Acadia’s Nuplazid for Parkinson’s Psychosis: Advisory Committee Outcome Hinges on Clinical Meaningfulness

Weekly Highlights: March 21-25

Generics to Abuse-Deterrent Opioids Must Be “No Less Abuse-Deterrent” On All Routes of Abuse, FDA Draft Guidance Says

Part B Drugs At Risk Under Reference Pricing: Medicare Dashboard Suggests Logical Targets In AMD, PAH

FDA’s Next Step to Real-World Evidence: Prove That Real-World Studies Can Match Known RCT Results

Amphastar Naloxone Price Under Scrutiny On Capitol Hill; Opioid Abuse Response May Veer Into Rx Marketing Attacks

FDA Opioid Relabeling Reinforces New Treatment Guidelines: Use Alternative Pain Therapies First

FDA Advisory Committee Tracker: Prepare For An Epidemic Of Opioid-Abuse-Themes; DMD, Diabetes Product Reviews Too

Psoriasis Patient-Focused Drug Development Meeting: Burning, Itching, Fatigue Symptoms for Potential New Endpoints

Weekly Highlights: March 14-18