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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...

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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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What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 
• By Neena Brizmohun

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 
• By Eliza Slawther

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.