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First biosimilar mAb in oncology granted EU approval
23 February 2017 | By Niamh Marriott, Digital Editor
The European Commission has approved Truxima (biosimilar rituximab) for all indications of reference rituximab in the European Union.
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European Medicines Agency (EMA)
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EMA validates Gilead’s marketing application for their Hep C therapy
23 January 2017 | By 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...
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FDA extends review period for Eli Lilly’s rheumatoid arthritis drug
16 January 2017 | By Niamh Marriott, Digital Editor
The US Food and Drug Administration (FDA) has extended the review period for Eli Lilly and Incyte’s new drug application for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA).
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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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Phase II trial for F2G’s antifungal drug following EU approval
11 January 2017 | By 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
13 December 2016 | By 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.
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EMA to review Janssen’s plaque psoriasis monoclonal antibody
5 December 2016 | By 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...
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Novartis’ acute myeloid leukaemia drug granted FDA priority review
18 November 2016 | By Niamh Louise Marriott, Digital Content Producer
The FDA granted priority review to the PKC412 (midostaurin) new drug application as treatment for acute myeloid leukaemia...
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EC approval for Lilly’s soft tissue sarcoma drug Olaratumab
18 November 2016 | By 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...
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Mabion sign supply and commercialisation agreement with Mylan
10 November 2016 | By 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.
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FDA grants priority review for Novartis’ first-line treatment of HR+/HER2- advanced breast cancer
7 November 2016 | By 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)...
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Mundipharma announces EU regulatory submission for Nyxoid
4 November 2016 | By 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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Sanifit launches Phase II calciphylaxis study
20 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Calciphylaxis is a serious and rare condition characterised by vascular calcification and thrombosis leading to necrosis of the skin and fatty tissue...
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EU approval for Abeona’s gene therapy to treat Sanfilippo Syndrome Type A
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Gene therapy program ABO-102 for the treatment of patients with Sanfilippo syndrome type A (MPS IIIA), a rare autosomal recessive disease...
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‘Game-changing’ immunotherapy doubles head and neck cancer survival
10 October 2016 | By Niamh Louise Marriott, Digital Content Producer
An immunotherapy drug has been hailed as a ‘game changer’ after being found to greatly improve survival for patients with relapsed head and neck cancer...
