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Project Orbis Update: FDA Approves 23 Products Under Global Oncology Collaboration In 2024; Imfinzi Label Expansion Includes EMA As “Observer”
January 31, 2025
Prevision Policy Clips | Date Change: Prevision Policy/Friends Of Cancer Research Biopharma Congress Will Take Place April 7
January 31, 2025
HHS Vaccine Policy Stakes Made Clear During Senate HELP Hearing With RFK; Significant Adverse Impacts On Uptake Likely – Unless Issue Prevents His Confirmation
January 30, 2025
Prevision Policy Clips | Kennedy Confirmation Hearing Showcases Bipartisan Support For PBM Reform Legislation
January 30, 2025
RFK Confirmation Hearing Underscores Risks For Biopharma: “Overmedication” Is Key Theme, As Are Price Cuts; Kennedy Somewhat Softens Threatening Tone Towards FDA
January 29, 2025
Prevision Policy Clips | Federal Workforce Uncertainty Increases With “Buyout Offer”
January 29, 2025
Advisory Committee Tracker: Meetings Lost In Transition; Will Advisory Committee “Re-Set” Ever Occur?
January 28, 2025
Prevision Policy Clips | FDA Gag Order Now Extends To February 22
January 28, 2025
Prevision Policy Clips | FDA, NIH, CDC And CMS All Have “Acting” Directors
January 27, 2025
CMS “Fit-For-Purpose” RWE Guidance Includes Template For Study Protocols; Intended For Devices But Could Be Expanded To Drugs—If Administration Agrees
January 24, 2025
Prevision Policy Clips | It’s (Almost) Official: Sara Brenner Is Now FDA Principal Deputy Commissioner
January 24, 2025
BsUFA Regulatory Science Pilot Seeking Partners For Human Factors Research; Interim Report Coming Before Planned September Meeting; Update Event Happens Despite Communications Freeze
January 23, 2025
FDA Diversity Action Plans In Limbo, OCE “Project Equity” Webpage Goes Dark As Trump Executive Order On DEI Takes Effect
January 23, 2025
Prevision Policy Clips | HHS Confirmation Hearing Set For January 29: Robert Kennedy’s
January 23, 2025
“Acting” FDA Commissioner Brenner Brings Trump White House-Level COVID Response Experience, Expertise In Nanoscience To Interim Role
January 22, 2025
Prevision Policy Clips | Communication Blackout At FDA Amid Transition
January 22, 2025
Prevision Policy Clips | HHS Acting Head Is Dorothy Fink; FDA Leadership Still Unannounced
January 21, 2025
Price Negotiation Class Of 2027 Includes Four Oncologic Agents; GSK, AbbVie, BI And Pfizer Have Multiple Products Selected; Ozempic Is The Headliner
January 17, 2025
Prevision Policy Clips | GSK, BI, AbbVie and Pfizer Each Have Two Drugs Up For Negotiation In Year 2
January 17, 2025
FDA Rare Disease Hub “Policy & Portfolio Council” Is First Step In CBER/CDER Coordination; Hub Agenda For 2025 Includes Three Scientific Workshops
January 16, 2025
Prevision Policy Clips | FDA Draft Guidance On Peripheral Neuropathy Associated With Chemotherapy
January 16, 2025
Gene Therapy Policy Opportunities Under Trump: Will Sector Fit Well In “MAHA” Agenda?
January 15, 2025
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
January 15, 2025
Prevision Policy Clips | Democratic Roster For House Energy & Commerce Subcommittees: Health Subcommittee Ranking Member Will Be Colorado’s Diana DeGette
January 15, 2025
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
January 14, 2025
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