Oncology Immunotherapy Resistance Is Key Area Of Interest For FDA, Cancer Researchers; National Cancer Policy Forum Workshop Focuses On Need For Early Proof-Of-Concept

Prevision Policy Clips | FDA Commissioner Seeking Senior Advisors On Chronic Disease And Mental Health

GOP Takes The House: Biopharma-Related Oversight Likely To Hit CMS Harder Than FDA

FDA “Project Pragmatica” Kicks Off With Merck, Lilly Lung Cancer Combo Trial; Streamlined Design Gives Fast Answers On Overall Survival, OCE’s Pazdur Says

Prevision Policy Clips | CMS Coverage With Evidence Development Criteria Update: MedCAC Meeting Pushed Back To February

How To Inspect Decentralized Manufacturing Facilities Is Priority For FDA To Develop Advanced Manufacturing Frameworks

Ardelyx Tenapanor Wins At Advisory Committee; FDA Approval For Phosphate Reduction In Dialysis Patients Likely In Coming Months, But Patient Selection May Be Key Labeling Issue

Prevision Policy Clips | Sen. Bill Cassidy (R-La.) Is Likely Next Senate HELP Committee Ranking Member

FDA Details Quality Assessment Processes For Expedited Review Products In New MAPP; Sponsors Need More Than Priority Review Or AA “Alone”

OTAT Gene Therapy Patient Listening Session: Placebo-Controlled Trials Discourage Industry Investment, Advocates Say

Prevision Policy Clips | Sentinel Expands To Include Medicaid Data; Surveillance System Now Covers One-Third Of US Population

Prevision Policy Clips | Save The Date: Biopharma Congress To Take Place Feb. 13; CMS Principal Deputy Jon Blum Confirmed

Ardelyx Tenapanor Path Forward Likely Requires Responder Analysis; Combo Use With Phosphate Binders Could Be Consolation Prize If Advisory Committee Agrees

Prevision Policy Clips | GSK Restricts Zejula Second-Line Maintenance Indication After ODAC Meeting Scrubbed

Senate Stays Under Democratic Leadership; Committee Changes May Mean Tougher Oversight For FDA, Brand Industry

AZ/Avillion Budesonide/Albuterol Rescue Inhaler Headed For Approval In Adults After FDA Committee Review; Pediatric Indication Likely Needs More Data

Veru Sabizabulin EUA Turned Down By FDA Advisory Committee: Small Database Outweighs Large Mortality Benefit In COVID Trial

Prevision Policy Clips | FDA Planning Spring 2023 Workshop With AACR On Use Of Overall Survival Analyses

Prevision Policy Clips | NCATS Director Rutter Will Continue As Head of the National Center for Advancing Translational Sciences

Prevision Policy Clips | Part B Discarded Drug Rebate Deadline Will “Align” With Inflation Rebates, CMS Says

Veru Sabizabulin Severe COVID Mortality Benefit Likely Strong Enough To Support EUA – But FDA Wants Repeat Of Study As Condition For Authorization

Prevision Policy Clips | Verve’s Gene-Editing Drug For Hypercholesterolemia Placed On Clinical Hold By FDA

Avillion/AstraZeneca Asthma Rescue Inhaler Combo (Budesonide/Albuterol) Appears Headed To Approval; FDA Wants Advisory Committee Input On Pediatric Use

FDA To Expand KASA Quality Risk Assessment Platform To NDA/BLA Reviews Over Next Five Years After Public Endorsement From Advisory Committee

Prevision Policy Clips | Gene Therapy “Umbrella Trials” Guidance Finalized By FDA