Showing 15 posts of 383 posts found.


CHMP recommends marketing authorisation for Incyte’s pemigatinib

February 3, 2021
Research and Development EMA, Incyte

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the conditional marketing authorisation of Incyte’s pemigatinib for …

EMA grants marketing authorisation for Amarin’s heart attack treatment

February 1, 2021
Sales and Marketing Amarin, EMA

Amarin have been granted authorisation from the EMA to market a treatment that will reduce the chance of heart attacks …


COVID-19 vaccine data leaked online by hackers, EMA says

January 14, 2021
EMA, Pfizer, Vaccine, data

The EMA has confirmed that data relating to COVID-19 medicines and vaccines that was stolen by hackers in December have …


EU gives green light to Pfizer-BioNTech COVID-19 vaccine

December 22, 2020
Manufacturing and Production COVID-19, EMA, Pfizer, Vaccine

The EMA has recommended the Pfizer-BioNTech COVID-19 vaccine for use across the EU’s 27 countries, with the first doses set …


Pfizer and Merck KGaA secure CHMP recommendation for Bavencio in Europe for first-line maintenance of urothelial carcinoma

December 14, 2020
Sales and Marketing Bavencio, CHMP, EMA, Merck, Pfizer, pharma, urothelial carcinoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given its recommendation for …


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 …


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 …


Hackers breach EMA server to steal data on Pfizer/BioNTech’s COVID-19 vaccine

December 10, 2020
Research and Development COVID-19, EMA, Vaccine

Pfizer and BioNTech’s jointly-developed COVID-19 vaccine, which this week began to rolled out to elderly patients in the UK after …


EMA receives filing for Janssen’s twice-yearly schizophrenia jab

December 7, 2020
Sales and Marketing EMA, Janssen, schizophrenia

The European Medicines Agency (EMA) has received Janssen’s Marketing Authorisation Extension for paliperidone palmitate six-monthly (PP6M), an injectable therapy administered …


Top Ten most popular articles on Pharmafile.com this week

December 4, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Dupixent, EMA, UK, Vaccine, top ten

As the year winds to a close, excitement is rising around the efficacy and availability of COVID-19 vaccines around the …


Neurogene secures EMA orphan designation for gene therapy in rare, inherited aspartylglucosaminuria

December 3, 2020
Sales and Marketing EMA, Neurogene, aspartylglucosaminuria

The European Medicines Agency (EMA) has bestowed Orphan Drug Designation (ODD) to Neurogene’s adeno-associated virus vector (AAV) gene therapy in …


EMA receives Pfizer and BioNTech’s filing for conditional approval of COVID-19 vaccine in Europe

December 1, 2020
Manufacturing and Production, Sales and Marketing BioNTech, COVID-19, EMA, Pfizer, Vaccine

Pfizer and BioNTech have officially submitted their application to secure conditional marketing authorisation to the European Medicines Agency (EMA) for …


Guido Rasi steps down as EMA’s Executive Director, Emer Cooke to become first female in the role

November 13, 2020
Medical Communications, Research and Development, Sales and Marketing COVID-19, EMA, EU, pharma

Professor Guido Rasi, Executive Director at the European Medicines Agency (EMA), serves his final day at the European regulator today, …


EMA’s CHMP recommends conditional approval for Kite Pharma’s CAR T therapy for mantle cell lymphoma

October 20, 2020
Manufacturing and Production, Sales and Marketing CAR T, CAR-T, CHMP, EMA, kite pharma, lymphoma

Kite Pharma’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy known as KTE-X19 has received positive recommendation from the EMA’s …


Sanofi’s Dupixent chalks up CHMP recommendation for paediatric severe atopic dermatitis

October 19, 2020
Sales and Marketing Dupixent, EMA, Sanofi, atopic dermatitis

Sanofi’s interleukin-4 and -13 inhibitor Dupixent (dupilumab) has been given the recommendation of the European Medicines Agency’s Committee for Medicinal …

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