EMA: latest news - GoINPHARMA
Tuesday, 26 March 2019 - 13:38

EMA

Biogen’s Imraldi, biosimilar to Humira, approved in Europe

Biogen has announced that the European Commission has approved Imraldi, a biosimilar to Humira. The drug has been co-developed by a Biogen-Samsung Bioepis joint venture. It has been approved for the treatment of rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis…

European Commission approves Novartis’ Kisqali for breast cancer

Novartis announced that the European Commission approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer. The product is the first CDK4/6 inhibitor approved in Europe. The…

CHMP, positive opinions for new drugs

EMA CHMP recommended some medicines for approval at its November meeting. CSL Behring GmbH’s Afstyla (lonoctocog alfa) received a positive opinion for the prevention and treatment of bleeding in patients with haemophilia A.Gilead’s Vemlidy (tenofovir alafenamide)was recommended for the treatment…

CHMP gets OK for Sanofi’s fixed combination Lantus/lixisenatide

Sanofi has announced that EMA CHMP has adopted a positive opinion for the marketing authorization of Suliqua, the fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide. The Committee recommended the use of the product in combination with Metformin in…

EMA first authority worldwide to give access to clinical data on new drugs

The European Medicines Agency has decided to open access to clinical reports for new medicines authorized in the European Union. According to Vytenis Andriukaitis, European Commissioner for Health and Food Safety, transparency is an essential component in clinical research, hence…