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Isis Teams Up With Roche In Early-Stage Huntington’s Deal

 
• By Lisa LaMotta

The biotech’s latest tie-up is another validation of its technology that could help it garner further attention – and better economics – for some of its late-stage programs.

In another validation of its antisense technology, Ionis Pharmaceuticals Inc. announced April 8 that it has entered into a pre-clinical tie-up with Roche. The RNA therapeutics company already has partnerships with Biogen Inc., GlaxoSmithKline PLC, and AstraZeneca PLC, amongst others. The company is hoping that these early-stage partnerships will help bring interest to its later-stage programs.

Isis’ latest partnership will focus on therapeutics for the treatment of Huntington’s Disease (HD), a genetic brain disorder that manifests in people older than 30 and results in the loss...

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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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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.