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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...

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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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Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.