Pfizer Faces Skeptical FDA For Talzenna “All Comers” Prostate Cancer Indication, But Can ODAC Say No To Survival Benefit?

Janssen Darzalex Faspro For Smoldering Myeloma: PFS Benefit In “Precursor” Condition Doubted By FDA Ahead Of ODAC; New CBER Director Prasad Is Also A Skeptic

Genentech Columvi Confirmatory Trial Questioned By FDA; ODAC Will Be Asked If Positive Results Apply To US Population Given Impact Of China/Asia Patients On Efficacy Outcomes

Prevision Policy Clips | GDUFA IV Reauthorization Kick-Off Meeting Set For July 11, FDA Formally Announces July 14 PDUFA VIII Public Meeting

Prevision Policy Clips | Biohaven Troriluzole For SCA Will Go Before An FDA Advisory Committee

RFK Embraces Streamlined Development Path For New Drugs During Budget Hearings; Says Industry 340B Concerns Need Attention, But Pledges To Protect Rural Providers

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Prevision Policy Clips | Price Negotiation For Year 3: CMS Leaves Key Product Selection Criteria Unchanged In Draft Guidance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