Vertex “Breakthrough” Non-Opioid Pain Treatment Journavx Breaks Through FDA Communication Blackout; Pregnancy Safety Will Be Post-Market Activity

CMS Prepares For Oz: Former Finance Staffer Carlton Is “Acting” Administrator And Expected To Be Chief Of Staff; Trump 1.0 Veterans Brooks, Brandt And Sutton Return

Kennedy Keeps It Vague: HHS Nominee Moving Forward Without Much Clarity On Drug Pricing Plans Or How “MAHA” Will Translate To Policy

Prevision Policy Clips | CMS Prepares For Oz: New Leadership Posted Online Includes Acting Administrator

FDA Guidances Have Been Edited To Comply With “DEI” Orders – But With No Notice Of Updates; HHS-Wide Communications “Pause” Continues

Prevision Policy Clips | Kennedy Confirmation Vote For HHS Set For Feb. 4 In Finance Committee

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