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Preapproval Information Exchange With Payers: Guidelines Codified In Omnibus Spending Bill

 
• By Cathy Kelly

Legislation, known as PIE Act, does not force manufacturers to share information on pricing or economic models with payers but aligns with the requirements in US Food and Drug Administration guidance.

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Payers Hoping That Law Will Whet Manufacturers' Appetite For Sharing • Source: Shutterstock

Pharmaceutical manufacturers can feel more comfortable about proactively exchanging information with payers on drugs before they are approved now that legislation codifying the practice has passed in the US Congress.

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• By Cathy Kelly

The preliminary budget document supports legislation clawing back funds appropriated for the program.

Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 
• By Eliza Slawther

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EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
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Medicare Price Negotiation: Trump Order Adds Momentum To ‘Pill Penalty’ Fix

 
• By Cathy Kelly

Wide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions.

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ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 
• By Bridget Silverman

US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease