EMA
J&J’s one-shot COVID-19 vaccine approved by European Commission
March 12, 2021Medical Communications COVID-19, EMA, Johnson & Johnson
The European Commission has granted Johnson and Johnson’s single-shot COVID-19 vaccine Conditional Marketing Authorisation (CMA), it was announced on Thursday. …
CHMP recommends Lilly’s bamlanivimab for COVID-19 patients
March 8, 2021Sales and Marketing COVID-19, EMA, Eli Lilly
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for Eli Lilly’s bamlanivimab …
Ipsen receives CHMP recommendation for Cabometyx in combination with Opdivo
March 1, 2021Sales and Marketing Cancer, EMA, ipsen
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Ipsen’s Cabometyx (cabozantinib) in combination with …
CHMP recommends marketing authorisation for Incyte’s pemigatinib
February 3, 2021Research 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, 2021Sales 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, 2021EMA, 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, 2020Manufacturing 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, 2020Sales 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, 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 …
Hackers breach EMA server to steal data on Pfizer/BioNTech’s COVID-19 vaccine
December 10, 2020Research 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, 2020Sales 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, 2020Business 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, 2020Sales 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, 2020Manufacturing 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 …
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