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Eylea, Avastin Both Get A Boost From NIH Comparative Study In DME

 
• By Cathy Kelly

The first head-to-head comparison of Eylea, Avastin and Lucentis in diabetic macular edema shows a superior benefit for Eylea in patients with more advanced vision loss and that Avastin is as effective as the other two drugs in other patients.

Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) will benefit from results of an NIH-funded study showing the drug was more effective than Roche/Genentech Inc.’s Lucentis (ranibizumab) or Avastin (bevacizumab) in diabetic macular edema patients with more advanced vision loss.

Payers are likely to welcome results showing that Avastin, which is far less expensive than the other two drugs, was...

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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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AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
• By Francesca Bruce

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
• By Xu Hu

China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.