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BARDA Offering Vaccine Prizes Despite Opposition In Senate

 
• By Bowman Cox

US agency dangles $50m prize purse to reward development of the best COVID-19 vaccine patches even as Senate committee rebuffs chairman’s proposal on prizes for pandemic preparation reauthorization bill. But there are some key differences in approach.

crossing the finish line
when it takes prizes and patents to cross the finish line • Source: Shutterstock

The federal agency that develops medical countermeasures to quash pandemics will be handing out prizes to encourage the participation of an industry that objected even to studying the idea as part of the legislation reauthorizing pandemic preparedness.

The US Health and Human Services Department’s Biomedical Advanced Research and Development Authority is looking for a partner to manage a vaccine patch prize competition and perhaps others – and is seeking advice on how its Project NextGen initiative could use prizes more broadly as “pull

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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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US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.