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European Commission (EC) - Articles and news items

cabometyx-rcc-drug

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 […]

designation-orphan-drug

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…

insulin-novo-nord

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…

eu hepatitis c european market

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…

Revlimid

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…

Revestive

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…

adcetris

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…

zinbryta

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…

kyprolis

EC approves extended indication for Kyprolis in multiple myeloma

Industry news / 4 July 2016 / 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…

Zavicefta

AstraZeneca’s new antibiotic Zavicefta approved in the EU

Industry news / 28 June 2016 / Victoria White, Digital Content Producer

The EC has granted marketing authorisation for Zavicefta for the treatment of patients with serious Gram-negative bacterial infections…

odefsey

EC grants marketing authorisation to Odefsey in HIV

Industry news / 23 June 2016 / Victoria White, Digital Content Producer

The EC has granted marketing authorisation for Gilead’s once-daily single tablet regimen Odefsey for the treatment of HIV-1 infection in certain patients…

Takeda & Seattle Genetics announce positive data from trial for cutaneous T-cell lymphoma 

EC approves Gazyvaro plus bendamustine in follicular lymphoma

Industry news / 16 June 2016 / Victoria White, Digital Content Producer

The EC has approved Gazyvaro in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma…

 

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