Acrotech Confirmatory Study Plan For Lymphoma Drugs Not “Reasonable,” ODAC Says; Changes Likely After Pazdur Arm-Twisting In Latest Accelerated Approval Showcase

Prevision Policy Clips | “Thank You And Have A Great Day”: CMS Ends J&J Xarelto Patient-Listening Session Abruptly With No Agency Comments On What’s Next

Post-Market Evidence Generation: FDA Commissioner Califf Says “Common Lexicon” Is Coming; Priorities Include Reducing Data Redundancies

Merck Cough Therapy Gefapixant Review Hinges On Whether Cough Reduction Is Large Enough To Be Clinically Meaningful; PROs May Be Key Support – If Committee Agrees

FDA’s Pragmatic Approach To Pragmatic Cancer Trials: OS Is Only Viable Endpoint For Now, But Pared-Down Eligibility Criteria, Safety Data Can Be More Broadly Applied

Project Optimus Update: Discussion Has Shifted From “Why” To “How” To Do Dose Optimization, FDA Says; Friends Of Cancer Research White Paper Emphasizes Role For PROs

Prevision Policy Clips | FDA Shutdown Deadline Pushed To January 19 Under House Continuing Resolution

“Tough Love” On Accelerated Approvals: Acrotech's Folotyn, Beleodaq Delays Will Not Prompt Withdrawal – But FDA Is Declaring "Never Again" In ODAC Review

Prevision Policy Clips | Another PI3K-Inhibitor Goes Down: Bayer Pulls NDA Of Aliqopa After CHRONOS-4 Confirmatory Trial Fails To Meet Primary Endpoint

Prevision Policy Clips | Clinical Trial Diversity, Embracing “Learning-Based Analytical Tools,” Leveraging “Commonalities Across All Diseases” Are Key Priorities For NIH Director Bertagnolli

Prevision Policy Clips | Office Of Pharmaceutical Quality Reorganization To Take Effect January 14

Prevision Policy Clips | Jardiance CMS Patient-Listening Session Features Talk Of Benefits, More Concerns About Access After Negotiations

Rebate Pass-Through Bill Heads To Senate Floor: Amendment Directs GAO To Study Impacts Of New Policy; CBO Still Sees Costs Going Up; Biosimilar Tiering Provision Needs More Work

Prevision Policy Clips | NIH Director Bertagnolli: Senate Confirms Nominee 62-36 Despite Two “No” Votes From Democrats

Rare Disease Review Flexibility Will Be Focus Of National Academies Report; Kick-Off Meeting Highlights Disconnect Between FDA’s Perceptions And Those Of Patients

Prevision Policy Clips | Real-Time Oncology Review Final Guidance Includes Modest Changes To 2022 Draft Version, FDA Says

Prevision Policy Clips | Novo Nordisk’s Novolog/Fiasp Insulin/Device CMS Patient Listening Session Features Overwhelmingly Pro-Negotiation Themes

Continuous Manufacturing Adoption Is Steady, But Slow; FDA Updates CM Progress, FRAME And QMM At Pharmaceutical Quality Symposium

Cardiovascular, Respiratory Drugs Would Test Rebate Pass-Through In Part D Under Senate Finance Bill; Would Also Require Favorable Formulary Status For Low-Cost Biosimilars

Prevision Policy Clips | CMS Finalizes 340B Drug Repayment Plan: $9 Billion Lump Sum Payment Will Go To Providers

The Personal Touch: FDA Continues To View In-Person Inspections As More Efficient Than Remote Alternatives; “Third-Country” Inspections Will Continue

Prevision Policy Clips | Entresto CMS Patient Listening Session Has Fewer Patient Speakers, Half Are Repeats, With Themes Of Pro-Negotiation And Concerns Over Formulary Restrictions

Vertex Exa-Cel Off-Target Effect Screening Approach Convinces FDA Committee; First Gene Editing Therapeutic On Track To Approval

Prevision Policy Clips | Vertex Exa-Cel Sickle Cell CRISPR Gene Therapy Off-Target Safety Analysis Affirmed

FDA Enters A Critical 12 Months: Califf’s Legacy Year Starts With Shutdown Threat And Ends With Presidential Election