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

Drug Quantity Reporting: FDA Encourages Manufacturers To Submit Despite Absence Of Firm Deadline; Data Will Prioritize Inspections, Mitigate Shortages

Prevision Policy Clips | CMS Advisory Committee Review Of CED Criteria Scheduled For Dec. 7

Biden As The Biotech President? Biomanufacturing Executive Order Fits Uneasily Alongside Price Reduction Rhetoric In “Moonshot” Events

IRA Has “Not Negated” Need For Part B Drug Pricing Reforms, MedPAC Says; Proposals Moving Forward, But Congress May Not Agree

Prevision Policy Clips | OTC Switch Of Contraception Drug Opill Goes To A Joint FDA Advisory Committee Nov. 18

COA Development “Reframed” By PFDD Draft Guidance: FDA Looking For “Evidence-Based Rationale,” Does Not Expect Major Changes In Supporting Data

Prevision Policy Clips | Short Term User Fee Extension? Congress Is Considering

CBER Brings In Former Merck Exec Kaslow To Lead Vaccines Office, Allowing Director Marks To Re-Prioritize

CDC and FDA Discuss Decolonization Data To Support Products To Prevent Healthcare-Associated Infections: CDC Is Pushing For Advice On Types Of Studies To Help FDA Accept Surrogate Endpoints