Medicare Coverage Of Weight Loss Drugs: CBO Sees Slim Offsetting Savings From Use In Obese/Overweight Population; 10-Year Federal Cost Pegged At $35 Billion

Prevision Policy Clips | Medicare Coverage Of Obesity Agents Would Cost $35 Billion Through 2034, CBO Estimates

Stealth Bio Elamipretide For Barth Syndrome: Advisory Committee Is Last Chance To Head Off Rejection; FDA Says Data Do Not Support Efficacy

Re-Scoring The IRA: Part D Overhaul Costs Are Higher Than CBO Projected For 2025 – More Than Offsetting Higher-Than-Projected Price Negotiation Savings

Prevision Policy Clips | Hurricane Helene Underscores FDA Shortage Messages: Commissioner Califf

Prevision Policy Clips | Maximum Fair Price Based On Ex-US Pricing Would Reduce Rx Drug Prices By 5% “And Possibly Substantially More,” CBO Says

Rare Disease Project Proliferation At FDA: Agency Needs To Focus On Management Of Initiatives, National Academy Of Medicine Report Says

Prevision Policy Clips | FDA Women’s Health Research Roadmap

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