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European Medicines Agency (EMA) - Articles and news items

First biosimilar mAb in oncology granted EU approval

Industry news / 23 February 2017 / Niamh Marriott, Digital Editor

The European Commission has approved Truxima (biosimilar rituximab) for all indications of reference rituximab in the European Union (EU)…

EMA validates Gilead’s marketing application for their Hep C therapy

Industry news / 23 January 2017 / Niamh Marriott, Digital Editor

The application is supported by data from two Phase 3 studies, which evaluated 12 weeks of the fixed-dose combination in antiviral-experienced patients…

FDA extends review period for Eli Lilly’s rheumatoid arthritis drug

Industry news / 16 January 2017 / Niamh Marriott, Digital Editor

Baricitinib is also being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus, and a phase 3 trial for patients…

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…

Phase II trial for F2G’s antifungal drug following EU approval

Industry news / 11 January 2017 / Niamh Marriott, Digital Editor

F901318 is the first member of a novel class of systemic antifungal agents targeting life threatening mould infections and acting through a target…

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EMA to review Sanofi and Regeneron’s dermatitis drug application

Industry news / 13 December 2016 / Niamh Louise Marriott, Digital Editor

The European Medicines Agency (EMA) has accepted for review the marketing authorisation application for Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. The investigational biologic therapy Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) […]

guselkumab

EMA to review Janssen’s plaque psoriasis monoclonal antibody

Industry news / 5 December 2016 / Niamh Louise Marriott, Digital Editor

Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which has been shown to play a key role in the development…

Novartis’ acute myeloid leukaemia drug granted FDA priority review

Industry news / 18 November 2016 / Niamh Louise Marriott, Digital Content Producer

The FDA granted priority review to the PKC412 (midostaurin) new drug application as treatment for acute myeloid leukaemia…

EC approval for Lilly’s soft tissue sarcoma drug Olaratumab

Industry news / 18 November 2016 / Niamh Louise Marriott, Digital Content Producer

This conditional marketing authorisation is based on data from the Phase 2 portion of the pivotal JGDG trial and followed a positive recommendation from…

Mabion sign supply and commercialisation agreement with Mylan

Industry news / 10 November 2016 / Niamh Louise Marriott, Digital Content Producer

Mabion signed a long-term development and commercialisation agreement with Mylan Ireland a wholly owned subsidiary of Mylan N.V. for its biosimilar…

FDA grants priority review for Novartis’ first-line treatment of HR+/HER2- advanced breast cancer

Industry news / 7 November 2016 / Niamh Louise Marriott, Digital Content Producer

The US Food and Drug Administration (FDA) accepted Novartis’ new drug application (NDA) for filing and granted priority review for LEE011 (ribociclib)…

Mundipharma announces EU regulatory submission for Nyxoid

Industry news / 4 November 2016 / Niamh Louise Marriott, Digital Content Producer

Studies showed that Nyxoid is bioequivalent to injectable naloxone as a first line treatment for opioid overdose, with an intranasal 1.8 mg dose…

 

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