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European Commission (EC) - Articles and news items

Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment

Industry news / 28 April 2017 / 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…

AstraZeneca’s lung cancer drug receives full approval in the EU

Industry news / 27 April 2017 / Niamh Marriott, Junior Editor

The EC has granted full marketing authorisation for AstraZeneca’s Tagrisso for the treatment of mutation-positive non-small cell lung cancer (NSCLC)…

BioMarin receives positive CHMP opinion for fatal brain disorder treatment in children

Industry news / 26 April 2017 / 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…

Novartis’ lung cancer drug combination receives EU approval

Industry news / 5 April 2017 / Niamh Marriott, Junior Editor

The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat fnon-small cell lung cancer…

Novartis receives positive CHMP opinion for lung cancer combination

Industry news / 27 February 2017 / Niamh Marriott, Digital Editor

The EMA approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with non-small cell lung cancer…

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)…

EU approval for Sanofi’s type 2 diabetes treatment

Industry news / 19 January 2017 / 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

EC approves Teva’s Acute Promyelocytic Leukaemia drug

Industry news / 28 November 2016 / 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…

Ferring receives positive CHMP opinion for IVF aid Rekovelle

Industry news / 19 October 2016 / 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…

TiGenix’s Crohn’s disease drug granted Swiss orphan drug designation

Industry news / 18 October 2016 / 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…

AbbVie receives CHMP positive opinion for Venclyxto (venetoclax) to treat chronic lymphocytic leukaemia

Industry news / 18 October 2016 / 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…

EC approves Ipsen’s cabometyx to treat advanced RCC following VEGF-targeted therapy

Industry news / 16 September 2016 / 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 study in previously treated patients […]