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Too Late For Amyloid: Bill Would Prevent Future Class-Wide Coverage Decisions By Medicare

 
• By Sarah Karlin-Smith

House Energy and Commerce health subcommittee easily clears a bill that would prevent another class-based national coverage determination from Medicare, but with an amendment clarifying it is for prospective decisions only, making it too late for new Alzheimer’s drugs.

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A bill cleared by a House subcommittee would prohibit class-wide NCDs by Medicare. • Source: Shutterstock

Medicare would be prevented from making a national coverage determination that applies to an entire class of drugs or biologics under a bipartisan bill that easily cleared the House Energy and Commerce health subcommittee, but despite the bill’s authors indicating the recent Alzheimer’s NCD was the inspiration for the legislation, an amendment was made to clarify that the policy would not apply to past decisions.

H.R. 133,

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.