ICER Hemophilia Gene Therapy Reviews: FDA Labels Watched For Impact On Coverage; Uptake May Be Slowed By Patient Caution/Payer Controls

Prevision Policy Clips | Genentech Pulls Tecentriq Urothelial Carcinoma Indication, Following Through On Timeline

Advisory Committee Tracker: “Non-Inferiority” Will Be Theme Of Early 2023 Reviews Of Eylea Pediatric Trial And Cidara/Melinta Antifungal

FDA “Project FrontRunner” Case Study: Can Agency Move Multiple Myeloma Drug Development To Earlier Disease Stages?

Prevision Policy Clips | Sarepta DMD Gene Therapy BLA Gets Priority Review, May 29, 2023 Action Date

Prevision Policy Clips | A New Drug Pricing Milestone: $3.5 Million Per Dose Will Be List Price For Hemgenix

“Project FrontRunner” Is Oncology Center’s Push For Culture Change In Treating Earlier-Stage Disease With AA – And Guaranteeing Timely Confirmatory Studies

Prevision Policy Clips | GSK Will Withdraw Blenrep At FDA’s Request; Compassionate Use Will Be Available

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