OTAT’s Bryan Offers Broad Framework For Accelerated Approval For Gene Therapies: Biomarker + Evidence Of “Clinical Effect”

ODAC Votes Secura’s Duvelisib Has Unfavorable Benefit-Risk Profile As FDA Sets Stage For Withdrawal; OCE’s Pazdur Silent, Gormley Takes Lead

Prevision Policy Clips | RMAT Designation Success Rate Is 37% For Cell/Gene Therapies, CBER/OTAT Director Wilson Bryan Says

ODAC Votes Down Spectrum Poziotinib For Rare NSCLC Subtype; Efficacy And Safety May Be Acceptable, But FDA Dosing, Confirmatory Trial Concerns Prevail

Prevision Policy Clips | User Fee Deal Reached For A Clean Five-Year Reauthorization To Be Attached To Continuing Resolution

OncoPeptides Pepaxto Withdrawal Endorsed By FDA Committee, But Sponsor Seems Likely To Resist; Pomalyst Caught In The Crossfire?

ICER Obesity Class Review Could Impact Potential Changes To Coverage Rules, Advocates Say; Panel Does Not See Novo’s Wegovy As Cost Effective

Prevision Policy Clips | Accelerated Approval “On-Ramp”/“Off-Ramp” Strategies, “Uncertain Relationship” Of Response Rate To Survival

CREATES Act Path For Obtaining Brand Samples Outlined In FDA Draft Guidance; “Covered Product Authorization” Replaces “Safety Determination Letter”

Bluebird Opens AA Pathway For Gene Therapies With Skysona CALD Approval; FDA Appears To Have Pushed Accelerated Route

Secura’s Copiktra: FDA “Re-Evaluation” Of Benefit-Risk Profile In Light Of Adverse Survival Data Aimed At Pulling “Regular” Approval

Rebiotix Microbiome Enema Rebyota: FDA Asks Committee To Review Bayesian Attempt To Make Single Phase 3 Study Adequate

Biosimilar Development: Comparative Clinical Studies Are A “Blunt Tool” That Is Still Needed, Though FDA Sees A Future Without Them

Prevision Policy Clips | FDA Reviewing Status Of GSK Zejula Recurrent Ovarian Cancer Indication

Spectrum Poziotinib Faces Tough Review From ODAC; FDA Declares Drug Would Be “Least Effective Targeted Therapy For Lung Cancer” If Approved

OncoPeptides’ Pepaxto Future In US Hinges On Finding Lower Effective Dose; ODAC Review May Set-Up Fight With FDA To Delay Withdrawal

Prevision Policy Clips | FDA Pushes Back Veru Sabizabulin COVID Antiviral Advisory Committee Review

Prevision Policy Clips | Accelerated Approval Comes To Gene Therapy: Bluebird Skysona

The Future Of Patient-Focused Drug Development: FDA’s Mullin Proposes “National Catalogue” Of COAs

PREVENT Pandemics Act Pushed By Senate HELP Leadership: Monkeypox Response Shows Need For “Clear, Consistent” Authority, Sen. Burr Says

FDA Commissioner Califf In Hot Seat Over Monkeypox Response: Delayed Jynneos Vaccine Doses Topic At Senate HELP Hearing

FDA Outlines Labeling Applications For “Functional Medical Queries” At Duke Meeting; Standardization For Pre-Market Safety Analytics Is Key Goal

Prevision Policy Clips | Continuing Resolution Expected To Be Introduced Next Week, With User Fees Attached

Prevision Policy Clips | Medicare Advantage Prior Authorization Overhaul Clears House; Part D Drugs Exempt

Prevision Policy Clips | FDA Wants More Notice Before Advisory Committee Members Appear On Behalf Of Individual Sponsors