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Elusive EU Clinical Trial Rules Slip Again -This Time To Late 2018

 
• By Ian Schofield

The schedule for getting the EU's clinical trial portal and database up and running seems to have slipped again, this time by almost a year compared with earlier estimates. As currently forecast, the new system is not likely to be in place, or the provisions of the new Clinical Trial Regulation (CTR) in effect, until the autumn of 2018.

The schedule for getting the EU's clinical trial portal and database up and running seems to have slipped again, this time by almost a year compared with earlier estimates. As currently forecast, the new system is not likely to be in place, or the provisions of the new Clinical Trial Regulation (CTR) in effect, until the autumn of 2018.

It's not clear why the new "delivery time frame", which has just been endorsed by the European Medicines Agency's management...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

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• By Nielsen Hobbs

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Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

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Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

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• By Bridget Silverman

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Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.