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Sandoz receives EU approval for Erelzi (biosimilar etanercept)
The European Commission (EC) has approved Sandoz’ (a Novartis division) Erelzi (biosimilar etanercept) for use in Europe, to treat inflammatory diseases...
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European Commission (EC)
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EU approval for Regeneron and Sanofi’s rheumatoid arthritis drug
The European Commission (EC) has granted marketing authorisation for Regeneron and Sanofi’s Kevzara (sarilumab) for the treatment of rheumatoid arthritis...
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First treatment for 5q spinal muscular atrophy approved by EU
1 June 2017 | By Niamh Marriott, Junior Editor
The EC has granted marketing authorisation for Ionis Pharmaceuticals’ Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA)...
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New EMA guidelines on biosimilar medicines
1 June 2017 | By Niamh Marriott, Junior Editor
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines...
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Brilique (ticagrelor) new formulation gains European approval
25 May 2017 | By Niamh Marriott, Junior Editor
The European Commission has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new formulation...
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Biosimilar medicines: Dramatic increase in patient access across Europe
23 May 2017 | By Niamh Marriott, Junior Editor
Biosimilar medicines have dramatically increased patient access to biological medicines, according to the recently published QuintilesIMS report...
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EC opens formal investigation into Aspen Pharma’s cancer drug price hikes
17 May 2017 | By Niamh Marriott, Junior Editor
The EC has opened a formal investigation into concerns that Aspen Pharma has engaged in excessive pricing concerning five life-saving cancer medicines...
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Market pressures and inadequate production restrict access to antibiotics
15 May 2017 | By Niamh Marriott, Junior Editor
Antibiotics are becoming more difficult to access, mostly because the drugs are less profitable for manufacturers to produce and market...
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EC extends approval for Janssen’s daratumumab to include multiple myeloma patients
3 May 2017 | By Niamh Marriott, Junior Editor
The EC has granted approval to Janssen Daralex (daratumumab) for use in combination, for the treatment of adult patients with multiple myeloma (MM)...
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Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment
28 April 2017 | By Niamh Marriott, Junior Editor
The European Medicine Agency's CHMP has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ Kevzara...
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AstraZeneca’s lung cancer drug receives full approval in the EU
27 April 2017 | By Niamh Marriott, Junior Editor
The European Commission (EC) has granted full marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
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BioMarin receives positive CHMP opinion for fatal brain disorder treatment in children
26 April 2017 | By Niamh Marriott, Junior Editor
CHMP has adopted a positive opinion for the company's MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease...
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Novartis’ lung cancer drug combination receives EU approval
5 April 2017 | By Niamh Marriott, Junior Editor
The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat fnon-small cell lung cancer...
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Novartis receives positive CHMP opinion for lung cancer combination
27 February 2017 | By Niamh Marriott, Digital Editor
The EMA approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with non-small cell lung cancer...
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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.
