Prevision Policy Clips | NIH “Generation Gold Standard” Vaccine Initiative Targets 2029 FDA Submissions For Two Universal Flu

Price Negotiation Year Two: CMS Town Hall Shows Little Change In Tone Under Trump; Ozempic, Trelegy Ellipta, And Xifaxan Get Mixed Comments

FDA Opioid Advisory Committee Will Consider Labeling Changes To “Quantify” Risks Based On Post-Marketing Trials; First Panel Of Kennedy/Makary Era Will Still Include Industry Rep

House Energy & Commerce Committee Advances Six Bipartisan Health Bills; PBM And PRV Measures Remain TBD

FDA Deadline Tracker: Missed Deadlines Make News In April After Layoffs To Start The Month

Prevision Policy Clips | Alliance For A Stronger FDA Applauds Commissioner Makary’s Decision To Drop Reorg Plan

Prevision Policy Clips | HHS Deputy Nominee O’Neill Confirmation Hearing Set For May 6

FDA Reorg Plan Will Not Move Forward, Commissioner Makary Says; “Single Center” Idea Appears Dead For Now: Possible Turning Point For FDA Under Trump?

Advisory Committee Tracker: COVID Booster Panel Could Be Tone-Setter For Makary’s Tenure – If It Happens; FDA Public Meeting Cancellations Continue Into Spring

Prevision Policy Clips | No FDA Reorganization Planned, Commissioner Makary Says

Prevision Policy Clips | Novavax COVID Vaccine Delay: Commissioner Makary Confirms Demand For Clinical Trial

Prevision Policy Clips | Merck, Bristol Reassure Investors That FDA Reviews Are Proceeding On Time For Now

340B Contract Pharmacy Restrictions’ Impact Is Waning, Manufacturers Tell Sen. Cassidy; Report Quantifies Effect On Lilly, J&J, And Amgen, Fuels Cassidy’s Call For Reforms

FDA Expands Catalogue Of Rare Disease Case Studies: New Examples Look At Surrogate Endpoints (Qalsody, Nexviazyme, Livdelzi), Externally Controlled Trials (Amvuttra) And Novel COAs (Bylvay)

Making “Cost-Effective” Drugs “Affordable”: ICER Obesity White Paper Offers Options To Expand Access To GLP-1s For Insurers, Policymakers To Consider

Prevision Policy Clips | FDA Rare Disease Case Studies Include Biogen’s Qalsody And Alnylam’s Amvuttra

FDA Layoff Impact On Review Activities Detailed By CDER In Letter To Vanda; Message In Context Of Dispute May Have Broader Audience In Mind

Prevision Policy Clips | Novavax COVID BLA Review: Company Asked For Post-Marketing Commitment “To Generate Additional Clinical Data”

MASH Histology Assessment AI-Assisted Tool Approved In Europe; Biomarker’s Qualification Is Ongoing At FDA

Nanoscope Retinitis Pigmentosa Treatment Would Benefit From Value-Based Contracting, ICER Says; Panel Revisits Ophthalmic Gene Therapy Seven Years After Luxturna

Prevision Policy Clips | OCE Loses Two More: Associate Director For Biomarkers And Precision Oncology Reena Philip

Conditional Approval Pathway For Ultra-Rare Conditions Based On “Plausible Mechanism” Floated By FDA Commissioner Makary

Prevision Policy Clips | CMS Center For Medicare Director Is John Brooks

FDA Advisory Committee Industry Reps Sacrificed To “Radical Transparency”; Commissioner Makary Defends FDA Cuts In On-Line Interview

Prevision Policy Clips | No More Industry Reps: FDA Advisory Committees Will No Longer Have Company Executives