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Prevision Policy Clips | Potency Assurance For Cell And Gene Therapies Draft Guidance Added To CBER Agenda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