EMA
Guido Rasi steps down as EMA’s Executive Director, Emer Cooke to become first female in the role
November 13, 2020Medical 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, 2020Manufacturing 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, 2020Sales 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 …
CHMP recommendation for Janssen’s Tremfya in active psoriatic arthritis
October 19, 2020Sales and Marketing CHMP, EMA, Janssen, Tremfya
Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) has scored a recommendation from the EMA’s Committee for Medicinal Products for Human Use …
EMA launches rolling regulatory review of Pfizer and BioNTech’s COVID-19 vaccine
October 7, 2020Research and Development, Sales and Marketing BioNTech, COVID-19, EMA, Pfizer, Vaccine
European Medicines Agency has launched a “rolling review” of the promising COVID-19 vaccine candidate BNT162b2 currently in development from BioNTech …
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 …
Kyowa Kirin’s Crysvita secures CHMP support in rare X-linked hypophosphataemia
July 28, 2020Manufacturing and Production, Sales and Marketing CHMP, EMA
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has given its backing to Kyowa Kirin’s …
Two CHMP recommendations for AstraZeneca: Imfinzi in first-line lung cancer, Calquence in chronic lymphocytic leukaemia
July 27, 2020Sales and Marketing AstraZeneca, CHMP, Calquence, EMA, Imfinzi
AstraZeneca has secured two new recommendations for approval of its products from the European Medicines Agency’s Committee for Medicinal Products …
EMA gives market authorisation application to epilepsy treatment from Arvelle Therapeutics
March 30, 2020Sales and Marketing EMA, EMA approvals, approvals, epilepsy
The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for a cenobamate adjunctive treatment of focal-onset seizures …
Ameluz approved by European Commission for treatment for actinic keratosis
March 11, 2020Research and Development EC, EMA, Europe, Lesions
Biofrontera AG has announced the European Commission has approved the use of their drug Ameluz in combination with photodynamic therapy …
Positive CHMP approval for Takeda’s Alunbrig in ALK+ advanced non-small lung cancer
March 4, 2020Research and Development CHMP, EMA, Takeda, lung cancer, pharma
Takeda’s Alunbrig (brigatinib) has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human …
Takeda’s subcutaneous vedolizumab nabs CHMP nod for maintenance of ulcerative colitis and Crohn’s
February 28, 2020Medical Communications, Sales and Marketing CHMP, EMA, Takeda, vedolizumab
Takeda’s subcutaneous formulation of its gut-selective biologic vedolizumab has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal …
AbbVie’s Venclyxto pins down CHMP approval for treatment-naive chronic lymphocytic leukaemia
February 3, 2020Sales and Marketing AbbVie, CHMP, EMA, Venclyxto, pharma
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has awarded recommendation to AbbVie’s Venclyxto (venetoclax), …
Novartis’ Beovu scores CHMP recommendation after proving non-inferior to Eylea in wet age-related macular degeneration
December 13, 2019Medical Communications, Sales and Marketing Beovu, EMA, Novartis, pharma
Novartis’ single-chain antibody fragment Beovu has secured recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use …
Jazz Pharma sleep disorder drug secures CHMP backing for treatment of excessive daytime sleepiness in Europe
November 18, 2019Research and Development, Sales and Marketing EMA, jazz pharma, narcolepsy, pharma, solriamfetol
Jazz Pharma’s solriamfetol has secured a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human …
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