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Roche’s Novel Ranibizumab Implant Among Myriad New Filings In EU

US Approval For Port Delivery System Expected Late 2021

 
• By Neena Brizmohun

The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.

Share close up view of human eye with data illustration, robotic concept
Age-related macular degeneration usually first affects people in their 50s and 60s • Source: Alamy

The European Medicines Agency has begun reviewing a new batch of EU marketing authorization applications (MAAs) covering a raft of drugs, including the investigational ranibizumab-based, refillable eye implant that Roche is developing to treat neovascular or “wet” age-related macular degeneration (nAMD).

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The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

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FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart

 
• By Sue Sutter and Derrick Gingery

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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
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The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.