Epizyme Benefits From ODAC With Added Sarcoma Specialists; 11-0 Vote Accepts Single-Arm Trial; Pazdur Puts Sponsor On Notice For Confirmatory Trial

Prevision Policy Clips | A Pretty Substantial Update: FDA Draft Guidance On “Demonstrating Substantial Evidence of Effectiveness”

FDA Self-Importation Guidance: Re-Pricing Work Around Moving Faster Than Broader Rule; Should Some Drugs Be Given “Special” Consideration?

State-Sponsored Import Plans Take One Step Forward With HHS Proposed Rule: Onerous Approach Could Yet Sink Under Its Own Weight – Or In Litigation

Prevision Policy Clips | State-Sponsored Canadian Drug Import Plans Are One Step Closer

ODAC Surprisingly Tight For Keytruda In High Risk Bladder Cancer Due To Delay Of Surgery Risk; FDA “Point/Counterpoint” Briefing Document “A Keeper”

AstraZeneca’s Lynparza Approval In Pancreatic Cancer Based On PFS Looks Favorable Despite Close Committee Vote; sNDA Benefits From “Pazdur Moment”

FDA Cancer Drug Approval Standards: Criticisms About Being “Too Fast” Are Really About The Price, Pazdur Says

CMS New Technology Payment Candidates For 2021: First-in-Class Treatments, And Two FDA-Pending CAR-Ts Plead Their Cases At Town Hall

Drug Price Debate Ends With A Whimper In 2019: CREATES Ready To Move With Year-End Funding Bill – Everything Else Carries Over

Prevision Policy Clips | 2019 Drug Price Debate Ends With Whimper: REMS “Abuse” (CREATES Act) Is Only Significant Provision

Epizyme’s Oral Tazemetostat For Rare Sarcoma Earns FDA Praise For Biologically Rational Approach, But Evidence Of Efficacy Is Low

Adherence Label Claims May Be On Horizon: FDA Reflects On How Sponsors Could Win Claims For New Formulations, Device/Drug, Patient Programs

Horizon Teprotumumab Easily Clears Committee For Rare Eye Disease: Label Will Include Warnings For Hearing Loss, GI Adverse Events; Glucose Testing Likely

Prevision Policy Clips | Senate Judiciary Opioid Hearing Dec. 17

FDA Drug Development Tool Guidance Outlines New Qualification Pathway; Timelines Sharpened, But Still Flexible

Keytruda For Bladder Cancer: ODAC Will Test “Point/Counterpoint” Briefing Document; Approvability Looks Set

AstraZeneca Lynparza For Pancreatic Cancer: FDA Asks Committee Whether “Modest” PFS Benefit Is Enough When OS Is Preferred Endpoint

Prevision Policy Clips | Sarpeta Golodirsen Approval Follows Successful Appeal, New Neurology Office Launch

Prevision Policy Clips | Hahn, HR 3 Votes This Afternoon

FDA Core Outcome Assessment Program Will Test Whether Academic Developers Working With FDA Grants Can Cut Duplication in Assessment Tools

House Price “Negotiation” Would Cut Global Sales For New Launches By 19%, CBO Estimates; Inflation Penalty, Part D Cap Estimates May Matter More

NASH Liver Disease Receives High-Level FDA Attention At Duke-Margolis Meeting; Reviewers Ready To Engage On First-Ever Treatments

Horizon Teprotumumab Likely Headed To Approval; Advisory Committee Focus Will Be Uncertainty On Duration Of Effect and Adverse Events In Rare Eye Disease

Correvio Vernakalant No Closer To US Approval After Committee Rejection; Enthusiasm For Further Studies Diminishes During Discussion