Prevision Policy Clips | Potency Assurance For Cell And Gene Therapies Draft Guidance Added To CBER Agenda

Ipsen’s Palovarotene For FOP: Challenges From Single-Arm Trial May Be Too Many For FDA Panel To Overcome But Agency Leaves The Door Open For A “Yes”

Prevision Policy Clips | Sarepta’s Elevidys: FDA Posts Summary Basis For Regulatory Action

CMS “Coverage Modernization Initiative” Will Increase Transparency In CED Process As Medicare Prepares For Lecanemab Coverage And Registry

Prevision Policy Clips | Preparing For Leqembi Coverage: CMS Provides New Details About Registry

Sarepta DMD Gene Therapy Starts As Product For 4–5-Year-Olds; Confirmatory Trial Due In Early 2024 Will Be Key To Possible Label Expansion

Prevision Policy Clips | AI Framework Unveiled By Senate Majority Leader Schumer To Include “New Legislative Approach” Of AI Insight Forums In The Fall

Prevision Policy Clips | Bluebird Bio Receives FDA Priority Review For “Lovo-Cel” Sickle Cell Gene Therapy, Dec. 20 PDUFA Date

Pediatric Oncology Clinical Studies Should Not Wait For Identification Of Optimal Adult Dose, FDA Advisory Committee Advises

Prevision Policy Clips | Oncology Drug/Companion Diagnostic Pilot Unveiled By FDA Through Guidance, Agency Will Take Nine Sponsors

FDA Tells Vaccine Manufacturers To Start Producing Monovalent XBB.1.5 COVID Vaccines After Unanimous VRBPAC Vote; CBER’s Marks Says Agency Will Stick To Annual Update Strategy

FDA Advanced Manufacturing Technology Pathway: Initial Launch At Year End Will Likely Be Updated With Experience, Agency Indicates

Prevision Policy Clips | VRBPAC Unanimously Supports Switch to Monovalent XBB COVID Vaccines

FDA Takes First Steps To Highlight Pediatric Dose Optimization For Targeted Oncology Drugs With Advisory Committee Meeting

Prevision Policy Clips | Senate Finance Leadership Introduces PBM Bill With Bipartisan Sponsors Headed By Chair Wyden And Ranking Member Crapo

Prevision Policy Clips | Partisan Disagreement On Inclusion Of Supply Chain Transparency Measures Dominates E&C PAHPA Legislative Hearing

FDA Supports Move To Monovalent Omicron XBB-Lineage COVID Vaccine For Coming Year With VRBPAC Likely To Go Along; Specific Sublineage Is Yet To Be Determined

Prevision Policy Clips | Senate HELP Committee Chair Sanders To Block Health Agency Nominees Until White House Produces Comprehensive Drug Pricing Strategy

Eisai/Biogen’s Leqembi For Alzheimer’s Gets Unanimous Endorsement From FDA Committee Clearing Way For CMS Coverage; Caution Expressed About Subgroups

FDA Rare Disease Endpoint Pilot Will Apply Public Disclosure Lessons From CID Pilot; Applicants Should Prepare For Time, Resource Commitment

Prevision Policy Clips | Chamber Of Commerce Sues HHS Over IRA Drug Price Negotiation Program Making It The Second Challenge

AstraZeneca/Sanofi’s Nirsevimab For RSV Shines During FDA Panel Review; Four Novel Prevention Options Could Be Available This Winter

Prevision Policy Clips | Iilun Murphy Is Permanent OGD Director, CDER's Corrigan-Curay Will “Assume Oversight” Of Generic Drugs

Prevision Policy Clips | Intarcia Continues Fight For Exanatide Twice-Yearly: FDA Will Hold September Endocrinologic And Metabolic Drugs Advisory Committee Hearing

Eisai/Biogen’s Leqembi Headed Toward “Full” Approval In Alzheimer’s: FDA Support Is Unequivocal; Committee Makeup All But Assures Positive Vote