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ICER Boosts ‘Cost-Recovery’ Benchmark Price For Remdesivir To Reflect Gilead’s Planned R&D

 
• By Cathy Kelly

But updated pricing model also suggests the more traditional ‘cost effectiveness’ benchmark price for remdesivir could be lower than previously estimated to account for use of dexamethasone in reducing the underlying risk of mortality in COVID-19 patients.

Coronavirus dollar bill
Price Modeling A Challenge In Rapidly Changing Environment

The Institute for Clinical and Economic Review has significantly increased its “cost recovery” benchmark price for Gilead Sciences Inc.’s antiviral remdesivir to account for the company’s planned research and development spending on the COVID-19 indication.

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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

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

 
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Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

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