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European Commission approves ocrelizumab for RMS and PPMS
Ocrelizumab provides a new treatment option for adults with active relapsing forms of multiple sclerosis...
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European Commission (EC)
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EC extends license for Zytiga to treat early stage prostate cancer
The EC has granted approval to broaden the existing marketing authorisation for Zytiga to include early stage metastatic prostate cancer...
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Methodology developed for assessing the value of new medicines
The Advance Value Framework has addressed the pitfalls of current approaches assessing the value of new medicines...
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Novartis combination targeted therapy receives FDA approval
The FDA has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer.
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Sandoz receives EU approval in Europe for Rixathon (biosimilar rituximab)
The EC has approved Sandoz’ Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine...
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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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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...
