Europe

Showing 15 posts of 198 posts found.

EC approves combination treatment for kidney cancer

March 31, 2021
Research and Development Cancer, Europe, oncology

The European Commission (EC) has approved Ipsen’s Cabometyx in combination with Opdivo as a first-line treatment for advanced renal cell …

spravato

Janssen’s esketamine nasal spray gets Europe approval for new indication

February 9, 2021
Manufacturing and Production Europe, Janssen

The European Commission (EC) has authorised the expanded use of Janssen’s Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in …

xellia

Xellia Pharmaceuticals becomes member of Medicines for Europe

January 21, 2021
Europe, xellia

Xellia Pharmaceuticals, a manufacturer of specialty anti-infective treatments, has become a member of Medicines for Europe. Medicines for Europe represents …

European approval for Kite’s CAR-T therapy Tecartus in elapsed or refractory mantle cell lymphoma

December 17, 2020
Sales and Marketing CAR-T, Europe, Gilead, Kite, Tecartus

Gilead-owned Kite Therapeutics has secured marketing authorisation from the European Commission for its chimeric antigen receptor (CAR) T cell therapy …

astrazeneca_building_white

EMA panel recommends label extension of AstraZeneca’s Imfinzi in non-small cell lung cancer

December 15, 2020
Manufacturing and Production, Sales and Marketing AstraZeneca, Europe, Imfinzi, NSCLC

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed a new dosing regimen of AstraZeneca’s …

european_commission

European approval for AstraZeneca’s Trixeo Aerospace in moderate to severe COPD

December 14, 2020
Sales and Marketing AstraZeneca, COPD, EMA, Europe, Trixeo Aerosphere

The European Medicines Agency (EMA) has announced the approval of AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) in the European Union …

spravato

Janssen’s esketamine nasal spray secures CHMP recommendation in Europe for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder

December 11, 2020
Medical Communications EMA, Europe, Spravato, depression

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has moved to recommend Janssen’s …

janssen_latest_logo_on_sign

European approval for Janssen’s Tremfya in active psoriatic arthritis, either alone or in combo

December 2, 2020
Research and Development, Sales and Marketing Europe, Janssen, Tremfya

The European Commission has authorised Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) in the treatment of active psoriatic arthritis (PsA), either …

Dupixent becomes first systemic medicine approved in Europe for children with severe atopic dermatitis

November 30, 2020
Sales and Marketing Dupixent, EU, Europe, Sanofi

The European Commission has moved to expand the existing authorisation of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union …

influenza

First recombinant influenza vaccine approved in the European Union

November 20, 2020
Medical Communications, Sales and Marketing Europe, influenza, pharma

The European Commission (EC) has just approved its first recombinant influenza vaccine for the European Union, awarding marketing authorisation to …

eu_member_flags

European Commission stands by €1bn remdesivir supply deal despite disappointing COVID-19 benefit

October 19, 2020
Manufacturing and Production, Sales and Marketing COVID-19, Europe, Gilead, remdesivir

As Europe continues to face down a rising second wave of COVID-19, the European Commission quickly moved to secure a …

shutterstock_2

Gilead to meet rising remdesivir demand in Europe with new supply deal

October 8, 2020
Manufacturing and Production COVID-19, Europe, Gilead

The European Commission (EC) has signed a new joint procurement agreement (JPA) with pharma firm Gilead to improve access to …

european_commission_web

Jyseleca secures European approval in rheumatoid arthritis

September 28, 2020
Research and Development, Sales and Marketing Europe, Jyseleca, arthritis, pharma

The European Commission has awarded approval to Gilead and Galpagos for their oral JAK inhibitor Jyseleca (filgotinib) as a treatment …

janssen_latest_logo_on_sign

Janssen’s Imbruvica secures label expansion in Europe in chronic lymphocytic leukaemia

September 7, 2020
Sales and Marketing Europe, Janssen, imbruvica, pharma

The European Commission (EC) has moved to expand the existing approval of Janssen’s Imbruvica (ibrutinib) in chronic lymphocytic leukaemia (CLL) …

EMA expands label for UCB’s Cimzia in axial spondyloarthritis

August 5, 2020
Research and Development, Sales and Marketing Cimzia, EMA, Europe

The European Medicines Agency has expanded the existing approval of UCB’s Cimzia (certolizumab pegol) to cover the treatment of axial …

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