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Medicare Seeks Input On Dispute Resolution, Civil Penalties For Rx Pricing Program

 
• By Cathy Kelly

Calculating a ‘fair price’ for new versions of already negotiated moiety is also one of several that CMS is requesting input on in its recently released initial guidance on the negotiation program.

Medicare Guidance Explains How Price Negotiation Will Work In First Year • Source: Shutterstock

While one section of the initial Centers for Medicare and Medicaid Services guidance on the drug price negotiation program is final, the agency is actively seeking comment, if quickly, on several other elements.

The 91-page guidance was released 15 March with a narrow 30-day window for public comments, which are due by 14...

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German Pricing System Is Tougher On Drugs Targeting Smaller Patient Populations

 
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The proportion of AMNOG benefit assessments leading to a positive rating, which has a direct impact on drug pricing, has decreased in recent years, according to analysis from the VFA, the association representing the German pharmaceutical industry.

Pink Sheet Podcast: US FDA Involved In Drug Pricing Deal, DOJ’s Off-Label Promotion Policy

 
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ViiV Secures English Funding For First Long-Acting HIV Prevention Injection

 
• By Neena Brizmohun

The National Health Service said the roll out of ViiV Healthcare’s Apretude would bring England closer to its aim of becoming the first country in the world to end HIV transmissions by 2030.

More from Pink Sheet

Initial Medicare Price Offer For Ozempic, Wegovy Almost Half Off Net, Analysis Suggests

 
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Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.

Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown

 
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Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.

Gene Therapy Sponsors Seek More US FDA ‘Platform’ Guidance, Offer Master File Idea

 
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One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.