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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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EU approval for Sanofi’s type 2 diabetes treatment
19 January 2017 | By Niamh Marriott, Digital Editor
Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe
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EC approves Teva’s Acute Promyelocytic Leukaemia drug
28 November 2016 | By Niamh Louise Marriott, Digital Editor
It is the first time that a form of acute leukaemia can be effectively treated with a regimen that is entirely chemotherapy-free...
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Ferring receives positive CHMP opinion for IVF aid Rekovelle
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Non-inferiority was demonstrated in a Phase 3 trial for the co-primary endpoints of ongoing pregnancy rate and ongoing implantation rate for Rekovelle...
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TiGenix’s Crohn’s disease drug granted Swiss orphan drug designation
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Cx601 is a suspension of allogeneic adipose-derived stem cells for the treatment of complex perianal fistulas in patients with Crohn's disease that have...
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AbbVie receives CHMP positive opinion for Venclyxto (venetoclax) to treat chronic lymphocytic leukaemia
18 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The CHMP recommends approval of venetoclax monotherapy in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have...
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EC approves Ipsen’s cabometyx to treat advanced RCC following VEGF-targeted therapy
16 September 2016 | By Niamh Louise Marriott,
The European Commission has approved Ibsen’s cabometyx (cabozantinib) 20, 40, 60 mg tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx (cabozantinib) demonstrated significant clinical benefits across all three efficacy endpoints (OS, PFS, ORR) in a phase 3…
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Orphan drug designation granted to Boehringer Ingelheim’s systemic sclerosis drug
13 September 2016 | By Niamh Louise Marriott, Digital Content Producer
Senscis is specifically evaluating nintedanib to understand the disease process and potential benefit of the compound to treat SSc-ILD...
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Novo Nordisk’s insulin pen receives EU expanded use approval to treat more patients with type 2 diabetes
2 September 2016 | By Niamh Louise Marriott, Digital Content Producer
The approval is based on data from the phase 3b clinical trial, which examined the efficacy and safety of liraglutide versus placebo as an add-on to existing diabetes medication, to improve glycaemic control...
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MSD’s Hepatitis C drug given green light for EU market
9 August 2016 | By MSD
Following successful phase 3 clinical trials, in which MSD’s new Hepatitis C drug, Zepatier, performed well, achieving high virologic cure rates across the study, the European Commission has licensed the drug for sale in the European market, specifically for the treatment of chronic hepatitis C virus (HCV) in adults with…
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EC approves Revlimid for mantle cell lymphoma
15 July 2016 | By Victoria White, Digital Content Producer
Celgene’s Revlimid (lenalidomide) has been approved by the EC for the treatment of adult patients with relapsed or refractory mantle cell lymphoma...
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Shire gets extended Marketing Authorisation for Revestive
7 July 2016 | By Victoria White, Digital Content Producer
The EC has granted an extension of the Market Authorisation for Revestive for the treatment of patients aged one year and above with Short Bowel Syndrome...
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EC extends conditional marketing authorisation for Adcetris
6 July 2016 | By Victoria White, Digital Content Producer
The EC has extended the current conditional marketing authorisation of Adcetris as consodlidation treatment in post-transplant Hodgkin lymphoma...
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EC grants marketing authorisation for Zinbryta in multiple sclerosis
5 July 2016 | By Victoria White, Digital Content Producer
The approval of Zinbryta is supported by results from two studies, including DECIDE, the largest and longest head-to-head Phase III study ever conducted in MS...
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EC approves extended indication for Kyprolis in multiple myeloma
4 July 2016 | By Victoria White, Digital Content Producer
The EC has approved a variation to the marketing authorisation for Amgen’s Kyprolis (carfilzomib) to include use in combination with dexamethasone alone...
