CMMI Will Look To More Drug Demos In Future Years, Sickle Cell Gene Therapy Model May Be Blueprint For Drugs That Get At “Root Causes” Of Conditions

Prevision Policy Clips | Finance Committee PBM Legislation Will Advance Following Reconciliation Process, Sen. Grassley (R-Iowa) Says

CMS Outlines Medicare Drug Price Re-Negotiation Process; Few Of First 25 Products Likely To Be Eligible – But Xarelto And Tradjenta May Be

Medicare Price Negotiation Year 3: CMS Proposes Tweaks But No Major Revisions, Suggests Biologic SubQ Combos May Not Be Separate From Original Brand

CBER Touts Cell/Gene Therapy “Platform Technology,” CMC Pilot To Speed Development; Others Float Public Cost Recovery Model For Rare Diseases

Prevision Policy Clips | Price Negotiation For Year 3: CMS Leaves Key Product Selection Criteria Unchanged In Draft Guidance

Drug Manufacturers Get Some Of What They Want In House Reconciliation Bill: Orphan Drugs Get A Reprieve; PBM Reforms Are Present, “Pill Penalty” Fix Is Absent

MFN Policy 2.0: Manufacturers Have 30-Day Window To Avoid New Pricing Rules Via Direct-To-Consumer Sales; International Price “Equalization” Is Goal

Prevision Policy Clips | MFN Policy 2.0: Manufacturers Have A Chance To “Negotiate”

Prevision Policy Clips | FDA TV? Commissioner Makary, CBER Director Prasad

Pushing AI At FDA: Agency Plans “Aggressive” Rollout For AI Platform To Aid “Scientific Review”; Commissioner Cites First “AI-Assisted” Review Milestone

Prevision Policy Clips | PDUFA Reauthorization Kick Off Meeting Set For July 14

Opioid Post-Marketing Studies Praised For “Rigor,” But FDA Committee Wary Of Labeling Changes; Discussion Highlights Ongoing Concerns About Long-Term Efficacy

HHS Deputy Nominee O’Neill Cites Value Of AI, Support For Medicare Drug Price Negotiation And Vaccines During Confirmation Hearing; RFK “Doing A Great Job”

Prevision Policy Clips | FDA Schedules Last-Minute ODAC Review Of Four Oncology Drugs May 20-21

CBER Director Vinay Prasad Solidifies FDA’s Anti-Industry Identity, Brings Increased Scrutiny To Use Of Accelerated Approval In Cancer, Gene Therapies

White House Drug Manufacturing EO Seeks To Streamline Domestic Site Inspections, Accelerate Foreign Audits – But RIFs, Long-Standing Challenges Will Be Reality Check

Prevision Policy Clips | FDA Directed To Streamline Domestic Inspections, Accelerate Foreign Ones

Prevision Policy Clips | FDA Not Mentioned In “Skinny Budget” Unveiled By Trump Administration May 2

BIOSECURE Likely to Be Reintroduced Soon In Modified Form; China-Focused Biotech Bills Could Proliferate In 2025

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