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Managing The World’s First Blockbuster Generic: An Interview With Sandoz’s George

 
• By Nielsen Hobbs

Jeff George, global head of Sandoz, talks about enoxaparin, a commitment to quality manufacturing, and investing in differentiated products.

Blockbusters are usually treated as the crowning achievement for pharmaceutical firms; discovering, developing and marketing a product with more than a billion dollars in annual sales is indeed profoundly difficult and rewarding. But sustaining that success can be even more challenging, as firms that have grown large on great products must work even harder to maintain their trajectory.

The difficulty of sustaining growth is felt even more acutely by generic firms, for whom exclusivity is usually measured in...

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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 Critical Medicines Act May Include Investigational Products & Mandatory Redistribution Measure

 
• By Neena Brizmohun

The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.

EU HTA Regulation: Key Gaps Identified In Support For Small Companies And Experts

 
• By Eliza Slawther

A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.