Prevision Policy Clips | First Topical Gene Therapy: Krystal Biotech’s Vyjuvek Approved By FDA For Rare Skin Disease

CBER Will Take “More User Friendly” Approach With Clinical Holds, Offer “Alternatives” To Sponsors; OTP Staffing Progressing Well

Pfizer’s Abrysvo RSV Vaccine In Infants Clears VRBPAC Despite Concerns About Premature Deliveries, Co-Administration; CBER’s Marks Chimes In At The End

Prevision Policy Clips | OTP Hiring Update: Acting Director Witten Estimates 40 Employees Hired At New Super Office Since Mid-February

Intercept OCA For NASH: Advisory Committee Review Pits Modest Efficacy In Unmet Need Against “Substantial” Safety Risks Seen By FDA

Prevision Policy Clips | Medicaid VBP Agreements For Gene/Cell Therapies Bill Goes To Full Committee

Prevision Policy Clips | Pediatric Drug Development Draft Guidances Provide Regulatory, Scientific Recommendations

Pfizer’s Abrysvo For RSV: FDA Has Overall Favorable View Of Vaccine In Infants With Strong Efficacy; CBER’s Marks To Participate

“Step Therapy” Regulations Added To Sanders/Cassidy PBM Bill; “De-Linking” Has Bipartisan Support: Pharma-Friendly Start To New Health Committee Era

ARS Intranasal Epinephrine Wins Strong Advisory Committee Support Despite Tough FDA Review; “Yes” Votes Swayed By Unmet Need For Needle-Free Alternative To EpiPen

Prevision Policy Clips | Oncology Center Of Excellence’s Project ASIATICA

Sarepta’s DMD Gene Therapy Wins Close Vote On Accelerated Approval; Advisory Committee Members Cite Patient Videos As Important Factor In Decision

Accelerated Approval Coverage Policy: House GOP Broadens Campaign For Access To Include CMMI; CMS “Clarifies” Position On Status Of AA Drugs

Prevision Policy Clips | ICER to Assess Merck’s Sotatercept for PAH

Prevision Policy Clips | Senate Finance Pharma Tax Hearing Lacks Bipartisan Goodwill

Senate HELP Hearing With Insulin Manufacturers, PBM Execs Produce Some Bad Optics And Scolding – But No Long-Term Policy Solutions

AI In Drug Development: FDA Discussion Paper Asks For Case Studies, Best Practices On Human Intervention, Data Quality, Model Development

Prevision Policy Clips | The Post-COVID Era Begins? Formal End Of “Public Health Emergency”

Opill OTC Switch Vote May Be Tough For FDA To Swallow: Committee Supports Broader Access Despite Starkly Negative Agency Review Of Perrigo/HRA “Actual Use” Data

Sarepta Showdown: FDA Review Of Gene Therapy For DMD Underscores Uncertain Benefit; CBER Leadership Role May Be Critical To Outcome

ARS’ Neffy Epinephrine Nasal Spray: Will New Route Of Administration For EpiPen Alternative Outweigh Uncertainties With PK/PD Approach?

Prevision Policy Clips | “Optimus” For Kids: Pediatric Oncology Committee Will Discuss Dose Optimization

Prevision Policy Clips | FDA Commissioner Califf Highlights Patient Engagement Efforts At Digital Health Event

Prevision Policy Clips | CDC Overhaul Will Be Led By New Director: Walensky To Step Down

Sarepta DMD Advisory Committee Has High-Profile Audience: FDA Commissioner Pressed To Allow More Public Speakers During Senate PAHPA Reauthorization Hearing