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EU Marketing Authorisation submitted for Ebola vaccine regimen
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
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Public consultation on key principles for ePI of EU medicines
The European Medicine Agency has launched a six month consultation on the principles that will form the basis of the electronic product information (ePI)...
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EMA accepts Marketing Authorisation Variation for Forxiga in adults with type-1 diabetes
First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes...
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European experts meet with Afican regulators to discuss collaboration
10 March 2017 | By 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…
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FDA accepts Mylan and Biocon’s biosimilar biologics license application
12 January 2017 | By 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
30 October 2013 | By 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
16 March 2012 | By Novartis
Potential first pharmacological treatment for symptomatic vitreomacular adhesion...
