Project Orbis Update: FDA Approves 23 Products Under Global Oncology Collaboration In 2024; Imfinzi Label Expansion Includes EMA As “Observer”

Prevision Policy Clips | Date Change: Prevision Policy/Friends Of Cancer Research Biopharma Congress Will Take Place April 7

HHS Vaccine Policy Stakes Made Clear During Senate HELP Hearing With RFK; Significant Adverse Impacts On Uptake Likely – Unless Issue Prevents His Confirmation

Prevision Policy Clips | Kennedy Confirmation Hearing Showcases Bipartisan Support For PBM Reform Legislation

RFK Confirmation Hearing Underscores Risks For Biopharma: “Overmedication” Is Key Theme, As Are Price Cuts; Kennedy Somewhat Softens Threatening Tone Towards FDA

Prevision Policy Clips | Federal Workforce Uncertainty Increases With “Buyout Offer”

Advisory Committee Tracker: Meetings Lost In Transition; Will Advisory Committee “Re-Set” Ever Occur?

Prevision Policy Clips | FDA Gag Order Now Extends To February 22

Prevision Policy Clips | FDA, NIH, CDC And CMS All Have “Acting” Directors

CMS “Fit-For-Purpose” RWE Guidance Includes Template For Study Protocols; Intended For Devices But Could Be Expanded To Drugs—If Administration Agrees

Prevision Policy Clips | It’s (Almost) Official: Sara Brenner Is Now FDA Principal Deputy Commissioner

BsUFA Regulatory Science Pilot Seeking Partners For Human Factors Research; Interim Report Coming Before Planned September Meeting; Update Event Happens Despite Communications Freeze

FDA Diversity Action Plans In Limbo, OCE “Project Equity” Webpage Goes Dark As Trump Executive Order On DEI Takes Effect

Prevision Policy Clips | HHS Confirmation Hearing Set For January 29: Robert Kennedy’s

“Acting” FDA Commissioner Brenner Brings Trump White House-Level COVID Response Experience, Expertise In Nanoscience To Interim Role

Prevision Policy Clips | Communication Blackout At FDA Amid Transition

Prevision Policy Clips | HHS Acting Head Is Dorothy Fink; FDA Leadership Still Unannounced

Price Negotiation Class Of 2027 Includes Four Oncologic Agents; GSK, AbbVie, BI And Pfizer Have Multiple Products Selected; Ozempic Is The Headliner

Prevision Policy Clips | GSK, BI, AbbVie and Pfizer Each Have Two Drugs Up For Negotiation In Year 2

FDA Rare Disease Hub “Policy & Portfolio Council” Is First Step In CBER/CDER Coordination; Hub Agenda For 2025 Includes Three Scientific Workshops

Prevision Policy Clips | FDA Draft Guidance On Peripheral Neuropathy Associated With Chemotherapy

Gene Therapy Policy Opportunities Under Trump: Will Sector Fit Well In “MAHA” Agenda?

FTC Keeps The Heat On PBMs With Second “Interim” Report; Unanimous Vote By FTC May Be More Significant Than Modest Cost Impact From “Specialty” Generic Pricing

Prevision Policy Clips | Democratic Roster For House Energy & Commerce Subcommittees: Health Subcommittee Ranking Member Will Be Colorado’s Diana DeGette

Ferring/Seikagaku Condoliase Approval Should Be Limited To Patients Who Fail Prior Radicular Pain Treatment, FDA Committee Says; Panel Predicts Overuse, But Majority See Benefits Outweighing Risks