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European Commission (EC) - Articles and news items

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 […]

Orphan drug designation granted to Boehringer Ingelheim’s systemic sclerosis drug

Industry news / 13 September 2016 / 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…

Novo Nordisk’s insulin pen receives EU expanded use approval to treat more patients with type 2 diabetes

Industry news / 2 September 2016 / 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…

MSD’s Hepatitis C drug given green light for EU market

Industry news / 9 August 2016 / 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 genotype 1 and 4 infection…

EC approves Revlimid for mantle cell lymphoma

Industry news / 15 July 2016 / 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…

Shire gets extended Marketing Authorisation for Revestive

Industry news / 7 July 2016 / 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…

EC extends conditional marketing authorisation for Adcetris

Industry news / 6 July 2016 / Victoria White, Digital Content Producer

The EC has extended the current conditional marketing authorisation of Adcetris as consodlidation treatment in post-transplant Hodgkin lymphoma…

EC grants marketing authorisation for Zinbryta in multiple sclerosis

Industry news / 5 July 2016 / 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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