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Proteus Digital Health’s Ingestible Sensor Reports When Granny Takes Her Meds

 
• By Shirley Haley

A signal transmitted by the embedded sensor when a pill dissolves is picked up by a Bluetooth-enabled skin patch and sent to a remote phone app, notifying a designated caregiver that dosing is on track – or not. Both Novartis and Otsuka are trying the technology, and Proteus is developing its own line of digitized generics.

Proteus Digital Health Inc. won FDA approval July 30 for technology that helps patients stay on track with their medicines by building sensors into the pills they swallow, but the medical device is bound for pharma as part of an integrated solution to one of health care’s knottiest problems: compliance.

The ingestible sensor will help the pharma industry bridge the “efficacy-effectiveness gap,” George Savage, Proteus co-founder and chief medical officer, said in an interview. Many wonderful drugs have been proven efficacious, but they are not effective because patients, who by and large want to be compliant, get busy or aren’t sure of what they’re doing after they leave the doctor’s office, he said

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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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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.