Price Negotiation Year Two: CMS Revamps Patient Input Process In Final Guidance, But Leaves Key Policies Unchanged, Including Hands-Off Approach To 340B

Prevision Policy Clips | CMS Revamps Patient Input Process For Price Negotiation Round Two

Prevision Policy Clips | FDA’s Office Of Inspections And Investigations Is Official

Realigning Drug R&D: FDA’s Cavazzoni Sees No “Magic Wand” To Encourage Innovation For More Common Diseases, Suggests IRA Is One Factor To Weigh

Prevision Policy Clips | AZ Andexxa Confirmatory Trial Will Be Reviewed By CBER Advisory Committee Nov. 21

FDA’s Global Strategy Needs To Be “Revitalized” With A More Transparent Global Supply Chain And Better Purchasing Behavior From Drug Companies, Califf Says

ATTR-CM New Entrants: ICER Impressed With Activity Of BridgeBio’s Acoramidis, Alnylam’s Vutrisiran; High Costs Are Concern, Especially For Combination Use

Prevision Policy Clips | HRSA Threatens Sanctions On J&J Over Proposed 340B “Rebate” Program

Advisory Committee Tracker: Stealth Bio Barth Syndrome Resubmission Heads To Panel; Applied Sciences Galactosemia NDA Will Not Need GeMDAC After All

PDL-1 “Negative” Patients Likely To Be Cut From Checkpoint Inhibitor Labels In GI, Esophageal Cancer; Keytruda (Merck), Opdivo (Bristol), Tevimbra (BeiGene) Affected

Merck, Bristol, BeiGene Urged To Support Biomarker Collaboration By OCE Director Pazdur During ODAC Review Of Proposed Label Restrictions

Prevision Policy Clips | Bristol-Myers Cobenfy Schizophrenia Approval

Gene Therapy “Now” Or “Die Waiting”? CBER Patient Listening Session Underscores Difficult Choices, FDA Focus On Long-Term Follow-Up And “Timely” Communications

FDA Rare Disease “Hub” Organization Builds On Existing Review Divisions Within CBER, CDER; Stability Will Benefit Application Reviews, CBER’s Tierney Says

Prevision Policy Clips | Pfizer Withdraws Sickle Cell Disease Drug Oxbryta Due To “Totality Of Clinical Data”

Senate HELP Chair Sanders Springs PBM Surprise On Novo At Hearing, But CEO Gives Strong Performance Under Pressure; International Reference Pricing Gets Cameo

Prevision Policy Clips | CBER AA For Rare Disease Gene Therapies Guidance Will Offer “Clear Expectations” On Data Required To Support Endpoints

Checkpoint Inhibitor Cut Points: ODAC Will Hear Case For Biomarker-Based Indications; Esophageal Relabeling May Be More Likely Than GI; Merck, Bristol, BeiGene To Present

Prevision Policy Clips | Rare Pediatric Disease Priority Review Voucher Reauthorization Bill Passes House

Medicaid Rebates: CMS Drops Price “Verification,” Rebate “Stacking” Proposals; “Misclassification” Policy Finalized Along With Other Technical Changes

Pertussis Challenge Models Are “Promising,” FDA Panel Agrees, But May Not Be Ready For Pivotal Efficacy Trials; Increasing Vaccination In Pregnancy May Be More Immediate Priority

Prevision Policy Clips | FDA Pediatric Voucher Program Would Be Extended To December 20 Under Continuing Resolution

Prevision Policy Clips | Patent Reform Bill Votes Postponed In Senate Judiciary Committee, Chair Dick Durbin (D-Ill.) Says

Re-Aligning R&D Incentives: CMS NTAP Program Offers Model For Encouraging Clinical Superiority Data, NASEM Committee Told

FDA Oncology Office Cautions Sponsors About Pitfalls Of Open-Label RCTs In Journal Article; Lumakras Is One Object Lesson