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Financings Of The Fortnight: Cutting-Edge Biomedical Technology Drawing Big Investments

 
• By Alex Lash and Stacy Lawrence

Juno Therapeutics and Moderna Therapeutics both leveraged promising technologies to bring home venture rounds of more than $100 million in recent weeks. Plus news on recent financings by Argos Therapeutics, Xencor, Sitari and 5am Ventures.

Digital future? Sounds both expensive and confusing! Instead, let’s talk about the recent past. What stood out for FOTF in this latest fortnight-plus – extended a bit to accommodate the Thanksgiving holiday – were two vast sums of money for companies plying cutting-edge biomedical technologies that, despite some successes in previous permutations, are still high-risk.

Let’s start with the second, because it’s a more obvious case. The company is Juno Therapeutics, which has rounded up a few programs of cancer immunotherapy under one corporate roof....

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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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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.