Europe
EC approves combination treatment for kidney cancer
March 31, 2021Research 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 …
Janssen’s esketamine nasal spray gets Europe approval for new indication
February 9, 2021Manufacturing 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 Pharmaceuticals becomes member of Medicines for Europe
January 21, 2021Europe, 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, 2020Sales 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 …
EMA panel recommends label extension of AstraZeneca’s Imfinzi in non-small cell lung cancer
December 15, 2020Manufacturing 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 approval for AstraZeneca’s Trixeo Aerospace in moderate to severe COPD
December 14, 2020Sales 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 …
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, 2020Medical 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 …
European approval for Janssen’s Tremfya in active psoriatic arthritis, either alone or in combo
December 2, 2020Research 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, 2020Sales 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 …
First recombinant influenza vaccine approved in the European Union
November 20, 2020Medical 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 …
European Commission stands by €1bn remdesivir supply deal despite disappointing COVID-19 benefit
October 19, 2020Manufacturing 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 …
Gilead to meet rising remdesivir demand in Europe with new supply deal
October 8, 2020Manufacturing 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 …
Jyseleca secures European approval in rheumatoid arthritis
September 28, 2020Research 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’s Imbruvica secures label expansion in Europe in chronic lymphocytic leukaemia
September 7, 2020Sales 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, 2020Research 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 …
Latest content
Long-acting therapies set to reshape HIV treatment market
MHRA approves Romvimza for tenosynovial giant cell tumour
