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Prevision Policy Clips | Potency Assurance For Cell And Gene Therapies Draft Guidance Added To CBER Agenda

June 27, 2023

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”

June 26, 2023

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

June 26, 2023

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

June 23, 2023

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

June 23, 2023

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

June 23, 2023

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

June 22, 2023

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

June 21, 2023

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

June 21, 2023

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

June 20, 2023

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

June 16, 2023

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

June 16, 2023

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

June 16, 2023

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

June 15, 2023

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

June 15, 2023

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

June 14, 2023

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

June 13, 2023

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

June 13, 2023

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

June 12, 2023

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

June 12, 2023

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

June 12, 2023

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

June 9, 2023

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

June 9, 2023

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

June 8, 2023

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

June 7, 2023
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