European Medicines Agency (EMA)

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The Success Story of Biosimilars

With their triumphant advance, biosimilars are also setting in motion the usual market mechanisms. Biopharma interest groups warn against the automatic substitution of originator drugs.

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EMA Reviewing Approval of Novartis’ Adakveo

The European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use (CHMP) has begun reviewing its marketing authorization for Novartis’ Adakveo, a medicine to prevent vaso-occlusive pain crises in patients with sickle cell disease.

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EMA’s CHMP Greenlights Omicron-1 Vaccines

The human medicines committee (CHMP) of EU drug regulator European Medicines Agency (EMA) has recommended approval of the updated Covid-19 vaccines of Pfizer-BioNTech and Moderna, combining protection against the original Omicron variant as well as the wild type that emerged in China in early 2020.

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