CMS Price Negotiation Listening Session For Eliquis Sets Template For Patient Input Events: Pro-Negotiation Patients, Formulary Placement Are Themes

Prevision Policy Clips | Sarepta Elevidys Confirmatory Trial Misses Primary Endpoint, But Company Will Seek Label Expansion

Prevision Policy Clips | Vertex/CRISPR “Exa-Cel” Advisory Committee Meeting Will Be Targeted Discussion Of Potential Off-Target Effects

Vertex/CRISPR Exa-Cel Advisory Committee Will Be Lesson On Off-Target Effects In Genome Editing: Sickle Cell Efficacy Is Clear; No Vote On Approvability

Advisory Committee Tracker: ODAC “Deliquent” AA Reviews Resume With Acrotech’s Folotyn, Beleodaq; Shutdown Threat Overhangs Future Schedule

Prevision Policy Clips | FDA Receives Stinging Criticism On Rare Diseases From Patients, Promising Pathway Act Gets Spotlight At Senate Aging Committee Hearing

FDA Is Concerned That CMC Work On BLAs For Cell/Gene Therapies May Not Be Keeping Pace With More Rapid Demonstrations Of Clinical Efficacy

Prevision Policy Clips | 340B Drug Discount Program Outpatient Pharmacy Registration Requirements Restored With End Of COVID Public Health Emergency

“Resilient” Trials: FDA Trial Disruption Workshop Stresses Implementation And Preparation; Industry Notes That Business Case For Decentralized Trials Is Yet To Be Proven

Prevision Policy Clips | FDA Hepatology Division Director Joseph Toerner Returns From Detail, Frank Anania Resumes As Deputy

Prevision Policy Clips | Senate HELP Committee Chair Bernie Sanders (I-Vt.) Urges HHS Inspector General To Investigate Proposed NIH Grant For Cervical Cancer Treatment

If The “SIUU” Fits: FDA Updates Off-Label Reprint Guidance With Broader Scope, Five Clearly Stated Principles, And New Acronym—Scientific Information On Unapproved Uses (SIUU)

Prevision Policy Clips | FDA Revises Draft Guidance On Manufacturer Communications Of Scientific Information To Health Care Providers Regarding Unapproved Uses

Menopausal Status Is Another Focus For FDA Trial Inclusion Efforts; Chronological Age Alone Is Not Enough To Rule Out Potential Drug Effects

FDA Benefit/Risk Framework: Final Guidance Affirms Decade-Old Tool As Central To Drug Reviews; Revisions From Draft Emphasize FDA’s Role As Decider—With Suggestions For Better Sponsor Input

Prevision Policy Clips | Net Prices Instead Of Gross Sales In Determining IRA Negotiation Selected Drugs? Energy & Commerce Health Subcommittee Chair Guthrie Expresses Interest

NIH Nominee Bertagnolli Is Noncommittal On “March-In” For High Drug Prices; Major Changes In Policy Seem Unlikely – But Will “Pricing” Clauses Return?

Generic Drugs In Part D: MedPAC Digging Into Claims Data, Supply Chain To Understand Price Variability

Prevision Policy Clips | FDA Benefit-Risk Assessment Final Guidance Includes Minor “Clarifying Language” Changes

“Project Pragmatica” Update: Lung Trial Accruing Well; Stakeholders Agree Explicit Assurance From FDA On Data Collection Will Encourage More Pragmatic Studies In Oncology

Prevision Policy Clips | NurOwn In ALS: “Only Path Forward” Is Second Phase 3 Study; BrainStorm Withdraws BLA

Prevision Policy Clips | Vertex/CRISPR Therapeutics Exa-Cel FDA Advisory Committee Review Is “Sensitive” But “Not Controversial"

Prevision Policy Clips | Medicare Part B Biosimilar Payment Enhancement Bill Is On Agenda For House Hearing

Prevision Policy Clips | CMS Expects “Consistent Coverage” Of Beta Amyloid PET Scans In Medicare, Following Removal of a 2013 National Coverage Decision

Orchard Arsa-Cel Gene Therapy For MLD Could Be Cost Effective At $2-$4 Million Per Treatment, ICER Review Suggests; Durability Is Key Variable In Value Assessment