European Commission (EC) - Articles and news items

Brilique (ticagrelor) new formulation gains European approval

Industry news / 25 May 2017 / Niamh Marriott, Junior Editor

The European Commission has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new formulation…

Biosimilar medicines: Dramatic increase in patient access across Europe

Industry news / 23 May 2017 / Niamh Marriott, Junior Editor

Biosimilar medicines have dramatically increased patient access to biological medicines, according to the recently published QuintilesIMS report…

EC opens formal investigation into Aspen Pharma’s cancer drug price hikes

Industry news / 17 May 2017 / 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…

Market pressures and inadequate production restrict access to antibiotics

Industry news / 15 May 2017 / Niamh Marriott, Junior Editor

Antibiotics are becoming more difficult to access, mostly because the drugs are less profitable for manufacturers to produce and market…

EC extends approval for Janssen’s daratumumab to include multiple myeloma patients

Industry news / 3 May 2017 / 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)…

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

 

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