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Comparison Study Of Lucentis, Avastin And Eylea In DME Starts With NIH Funding

 
• By Cathy Kelly

The study’s sponsor, the NIH-funded Diabetic Retinopathy Clinical Research Network, highlighted the cost disparity between treatments for diabetic macular edema in a summary of the study’s purpose.

The NIH-funded Diabetic Retinopathy Clinical Research Network is starting patient enrollment in August for a clinical study on the comparative effectiveness of Genentech Inc.’s products Lucentis (ranibizumab) and Avastin (bevacizumab) and Regeneron’s Eylea (aflibercept) in diabetic macular edema (DME), a sight-threatening complication of diabetes.

While the study will focus on the clinical effectiveness and safety of these treatments and is not designed as cost-effectiveness trial, the disparity in cost for these treatments is cited as a key driver in conducting the study, and it should provide clinicians with more definitive answers than currently available as to how well the

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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 Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.