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How To Spur Antibiotic Development? Higher Reimbursement, Govt. Funding Proposed By PCAST

 
• By Brenda Sandburg

President’s Council of Advisors on Science and Technology calls for establishment of infrastructure to support clinical trials and initiation of special medical use pathway; government to award $20 million prize for diagnostic to detect highly-resistant bacteria.

The federal government could provide higher reimbursement for new antibiotics as a way to incentivize companies to develop new therapies, the President’s Council of Advisors on Science and Technology (PCAST) recommends in its report on combatting antibiotic resistance.

PCAST offers several other suggestions for boosting commercial development, including that the government subsidize R&D programs for antibiotics; provide companies with a financial reward, such as a one-time lump payment, for bringing a new antibiotic to market; provide a tradable voucher that extends the patent life of another drug; and impose an

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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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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.

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By Vibha Sharma

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.