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EMA - Articles and news items

European experts meet with Afican regulators to discuss collaboration

Industry news, Ingredients, News, Quality Control / 10 March 2017 / Steve Bremer, Managing Editor

Representatives from the European Medicines Agency (EMA) met with medicines regulators from Africa last week to discuss how to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe. One of the tools discussed was the scientific assessment of medicines or vaccines for use outside the European Union that […]

FDA accepts Mylan and Biocon’s biosimilar biologics license application

Industry news / 12 January 2017 / Niamh Marriott, Digital Editor

This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers…

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New Marketing Authorisation Application submitted to EMA for Ibrutinib for the treatment of two forms of blood cancer

Industry news / 30 October 2013 / Johnson & Johnson

“The EMA Marketing Authorisation Application is an important milestone in the development of ibrutinib…”

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Alcon gains exclusive ex-US rights for ocriplasmin

Industry news, News / 16 March 2012 / Novartis

Potential first pharmacological treatment for symptomatic vitreomacular adhesion…