Rare Disease Priorities For 118th Congress: EveryLife Foundation Wants IRA Revision To Address Disincentive For Orphan Indications

Prevision Policy Clips | FDA Hostages Would Be Held An Extra Week Under Short Term Continuing Resolution

Prevision Policy Clips | Merck/Moderna Phase III Trial Of Melanoma Cancer Vaccine Combined With Keytruda

Cytokinetics Omecamtiv Faces Tough Vote On Efficacy In Heart Failure – And “Yes” From Panel May Still Mean More Work Ahead On Dosing Strategy

Prevision Policy Clips | Isotretinoin iPledge REMS Modifications Will Be Advisory Committee Topic March 28-29

Prevision Policy Clips | ICER Is Not On CMS “Radar” For Price Negotiation Input At This Point

“Development Safety Update Report” (DSUR) Proposed By FDA To Replace IND Annual Report; “Comprehensive” Scope, Harmonized With EU Approach

Prevision Policy Clips | “Development Safety Update Report” (DSUR) Proposed Rule Released By FDA: Overhaul Of IND Safety Update

Prevision Policy Clips | IRA Implementation: CMS Will Kick Off Monthly Calls With Manufacturers December 13

Prevision Policy Clips | CBER Director Peter Marks To Address PDUFA VII Implementation, OTAT Reorg At The Biopharma Congress Feb. 13

FDA Rewrites Bioequivalence Statistical Guidance: New Version Includes More Options Than Current (2001) Final Guidance

Prevision Policy Clips | FDA Finalizes Checkpoint Inhibitor PK-Based Dosing Guidance

Prevision Policy Clips | FDA Updating Generic Drug Bioequivalence Statistical Guidance

Prevision Policy Clips | Ferring Rebyota Milestones: First FDA Approval For Microbiota-Based Live Biotherapeutic

COVID Lessons Learned: FDA Oncology Office Encouraging Use Of Remote Trials Post-Pandemic; Friends/ACSO Collecting “Proof Of Concept” Data

Prevision Policy Clips | Bluebird Sells Priority Review Voucher To Argenx For $102 Million

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