Drug Pricing Timeline: A Speculative Look At 2019 Milestones

Prevision Policy Clips | HHS Pain Management Task Force Report Cautions Against “Misapplication” Of CDC Opioid Guidelines

Daiichi Pexidartinib Strong ORR Effect In TGCT Comes With Clear Concerns On Liver Injury; ODAC Faces Unusual Decision In Benign But Debilitating Tumor

FDA Interchangeable Biosimilars Final Guidance: Agency Softens Parameters On Ex-U.S. Switching Studies But Sets Strict Standard On Bridging Data

Daiichi Sankyo Quizartinib: FDA Questions “Credibility” Of Survival Benefit Heading To Panel; QT Safety May Doom Commercial Potential Even If Approved

FDA Ready To Listen To Alternative Strategies To Assess Renal Impairment Impact On Drugs, But Panel Concludes More Data Is Needed

Prevision Policy Clips | Gilead Truvada Donation Earns Positive Presidential Tweet

House Packages CREATES With ACA-Protection Riders, Complicating Consensus Approach To Drug Pricing Bills (For Now)

Orphan Drug Status And Gene Therapies: CBER Points To CAR-T Precedent, Suggesting Agency Will Allow Multiple Agents To Market Wherever Possible

FDA Panel Narrowly Recommends Approval Of Chiesi’s Bronchitol For CF Despite “Modest” Benefit, Negative Pulmonary Exacerbation Trend

FDA Flagging System For Real-World Data Submissions Is Another Small Step For Encouraging New Forms Of Evidence

Prevision Policy Clips | Therapeutic Equivalence Evaluations Draft Guidance Forthcoming

HHS Finalizes DTC Price Disclosure Rule: Impact On Ads and Prices Highly Uncertain – But Industry Now Agrees The List Price Matters

Senate Judiciary Chair Graham Accepts Consensus On CREATES; PhRMA Looks To Exclude Patents/IP Protections From Bill Riders

Prevision Policy Clips | DTC List Price Rule Finalized, Includes New Preemption Language

Generic Drug Legislation: Pricing Bills Could Complicate GDUFA III Negotiations

Tissue-Agnostic Oncology Drugs In The Real World: Proving Ground For RWE, But Access To Screening Is Key Commercial Barrier

Prevision Policy Clips | FDA to Study Accelerated Approval Disclosures in DTC Materials

CBER RMAT Update: 1/3 Of Requests Granted, Studies Of Small Populations OK, But Data Must Be “Compelling”

Chiesi’s Bronchitol For CF: FDA Appears Skeptical Despite New Positive Trial, Can The Pulmonary-Allergy Drugs Advisory Committee Resuscitate It?

Prevision Policy Clips | Orange and Purple Book Bills to House Floor May 8

Gene Therapy Facing Clinical Trial, Manufacturing Bottlenecks; Growing Pains Of Success In CNS Monogenic Disorders

CBO Rebate Rule Medicare Cost Projections Are Less Than CMS, But Confirm High Costs Of Dropping Rebates

Prevision Policy Clips | Pediatric ODAC Meeting, ADHD Drug Development Guidance, And House Tackles Drug Prices May 9

MedPAC “Drug Value Program” Gets Favorable Response During House Hearing As Alternative To International Pricing Index In Medicare Part B