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A Challenging Q3 For Novartis, But Diovan Generic Delay Offers A Reprieve

 
• By Jessica Merrill

The unexpected delay of U.S. generic competition to Diovan helped pad some of the impact felt by Novartis from the loss of exclusivity on the blockbuster hypertension drug. Still, the impact of generics weighed on Novartis’ third quarter sales, and the delay is only a temporary reprieve of the inevitable sales erosion.

The FDA has yet to approve a generic version of Novartis AG’s blockbuster hypertension drug Diovan (valsartan), although the drug lost exclusivity Sept. 21, and the unexpected delay in competition helped to buffer Novartis’ third quarter sales. Nonetheless, Novartis is in the midst of a challenging year due to manufacturing issues that have slowed production and the launch of other generic drugs, including the first versions of a fixed-dose combination including valsartan, Diovan HCT (valsartan/hydrochlorothiazide), both of which weighed on sales.

Plus, any reprieve from the delay of generic Diovan is only temporary, and management was quick to remind investors during a third quarter conference call Oct. 25 that the impact will be felt more acutely in 2013

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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.

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• 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.