7 Biosimilars, 2 ATMPs Among 81 Medicines That Got EMA Nod in 2016
Executive Summary
In 2016, oncology drugs again topped the list of medicines for which the European Medicines Agency recommended a centralized marketing authorization.
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On The Rise In The EU: New Drug Applications, Conditional Approval Recommendations
Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.
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Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.
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